{"id":"AIBD-1068","title":"China's CMDE finds that Tencent's MY-CJ-01 software raised first-pass polyp detection in the maker's randomized colonoscopy trial","summary":"China's CMDE found that first-pass polyp detection was superior in group B of Tencent's randomized MY-CJ-01 trial. The polyp miss rate was 23.39%, against 44.67% in group A.","date_observed":"2023-05-18","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Tencent Healthcare (Shenzhen) built MY-CJ-01, software that uses deep learning to mark suspected polyps in real time during colonoscopy. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the company's application for Class III registration. The trial was the maker's own, a prospective randomized superiority trial at two centers that enrolled 296 patients and analyzed 265. CMDE reports that group B outperformed group A on first-pass polyp detection, with a lower 95% confidence bound of 13.67% for the difference. The polyp miss rate was 44.67% in group A and 23.39% in group B. The report does not say how each group used the software. Group B presumably used it in the first examination, since CMDE counted its advantage as the product's superiority. The polyp detection rate was 62.50% in group A and 63.57% in group B, and withdrawal took slightly longer with the software. On 18 May 2023, CMDE judged that “该产品的上市为适用人群带来的受益大于风险” (marketing the product brings its intended patients more benefit than risk). It recommended approval, which NMPA announced on 1 June 2023.","category":"aggregate result","unexpected":false,"purpose":"Tencent Healthcare (Shenzhen) built MY-CJ-01 to mark suspected polyps in real time in the video of adult colonoscopies for endoscopists.","system":"MY-CJ-01 (结肠息肉电子内窥镜图像辅助检测软件)","model_version":"Release V2 (full version V2.0.0_build001)","developer":"Tencent Healthcare (Shenzhen) Co., Ltd. (腾讯医疗健康（深圳）有限公司)","deployer":"Tencent Healthcare (Shenzhen) (prospective randomized trial with 296 patients at two centers)","location":"Two trial centers that the report does not name, for a registration in China","domain":"Healthcare","segment":null,"benefit_type":"Improved Task Accuracy","work_activities":["4.A.1.b.1","4.A.1.a.2"],"taxonomy_note":null,"registry_ids":{},"ratings":[{"group":"organizational","depth":null,"reason":"The gain was measured in the maker's pre-market trial, and the report gives no outcome of care and does not say how each group used the software."}],"ai_role":{"status":"assessed","statement":"The randomized trial compared two groups of patients to test the software for superiority, so it isolates the software's part. The report does not say how each group used the software. Group B is presumed to have used it in the first examination because CMDE found its result superior. The trial was the maker's own."},"evidence":[{"kind":"regulatory document","citation":"Center for Medical Device Evaluation (CMDE), National Medical Products Administration, China. 医疗器械产品注册技术审评报告：结肠息肉电子内窥镜图像辅助检测软件 (technical review report for the registration of colon polyp electronic endoscope image detection-aid software), acceptance no. CQZ2200455, applicant 腾讯医疗健康（深圳）有限公司. 18 May 2023. Section 三、临床评价概述 (clinical evaluation), pp. 6-7.","title":"医疗器械产品注册技术审评报告：结肠息肉电子内窥镜图像辅助检测软件（CQZ2200455）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1686295172757009730.pdf","date":"2023-05-18","written_by":"independent","quote":"A 组息肉漏检率为 44.67% (95%CI:39.07%~50.42%)，B 组息肉漏检率为23.39% (95%CI:18.92%~28.54%)"},{"kind":"regulatory document","citation":"Center for Medical Device Evaluation (CMDE), National Medical Products Administration, China. 医疗器械产品注册技术审评报告：结肠息肉电子内窥镜图像辅助检测软件 (technical review report for the registration of colon polyp electronic endoscope image detection-aid software), acceptance no. CQZ2200455, applicant 腾讯医疗健康（深圳）有限公司. 18 May 2023. Section 四、产品受益风险判定 (benefit-risk determination), CMDE's own judgment.","title":"医疗器械产品注册技术审评报告：结肠息肉电子内窥镜图像辅助检测软件（CQZ2200455）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1686295172757009730.pdf","date":"2023-05-18","written_by":"independent","quote":"根据申请人提供的申报资料，经综合评价，在目前认知水平上，认为该产品的上市为适用人群带来的受益大于风险。"},{"kind":"regulatory document","citation":"National Medical Products Administration (NMPA), China. Computer-aided Detection Software for Electronic Endoscope for Colon Polyps Approved for Marketing. NMPA English website, 1 June 2023.","title":"Computer-aided Detection Software for Electronic Endoscope for Colon Polyps Approved for Marketing","url":"https://english.nmpa.gov.cn/2023-06/01/c_940345.htm","date":"2023-06-01","written_by":"independent","quote":"Recently, the innovative product computer-aided detection software for electronic endoscope for colon polyps of Tencent Healthcare (Shenzhen) Co., Ltd. is approved by China NMPA.","supports_benefit":false}],"replication":{"produced_by":["The software took the video stream from the endoscope's image processor and marked suspected polyps with a deep learning algorithm on a separate video client.","Patients at two centers were randomized to two groups in a prospective superiority trial."],"must_hold":["Patients are adults having colonoscopy in a medical institution.","The endoscope is a specified model used in white light mode.","Endoscopists judge polyps from the images and the patient's condition and do not decide on the marks alone."],"echoes":[]},"paired_incident":null,"headline":"*MY-CJ-01* raised first-pass polyp detection in Tencent's trial","metric":"The polyp miss rate was 23.39%, against 44.67% in group A","comparator":{"against":"Group A of the same randomized trial (the report does not say how each group used the software)","before":"Polyp miss rate 44.67% (95%CI:39.07%~50.42%) in group A","after":"Polyp miss rate 23.39% (95%CI:18.92%~28.54%) in group B","basis":"measured","quote":"A 组息肉漏检率为 44.67% (95%CI:39.07%~50.42%)，B 组息肉漏检率为23.39% (95%CI:18.92%~28.54%)","url":"https://www.cmde.org.cn/directory/web/cmde/images/1686295172757009730.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The gain was measured in the maker's pre-market trial, and the report gives no outcome of care, so no realized outcome is reported for any group.","brief_notes":null,"brief":null,"revisions":[{"date":"2026-11-01","change":"Added the record from the finding of the Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration.","source":"https://www.cmde.org.cn/directory/web/cmde/images/1686295172757009730.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: two independent regulatory documents. For the benefit itself, the cited sources include no independent study or report.","case_jurisdictions":["China"],"profile":{"case_id":"AIBD-1068","catalog_version":"1.0.0","source_fingerprint":"b3ee4f4c10c13a097a1661a4ef44cca43668e8cd4b328ed8eeeaaf931490f403","collection_refs":[{"collection_id":"aibd","version":"2026-10-31"},{"collection_id":"querist","version":"2026-10-25"}],"source_ids":["AIBD-1068-source-0001","AIBD-1068-source-0002","AIBD-1068-source-0003"],"families":{"strategic assessments":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"Editorial assignment.","review_state":"not_assessed","coverage":"partial","record_ids":[]},"evaluations":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"Editorial assignment.","review_state":"not_assessed","coverage":"partial","record_ids":[]},"monetary observations":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"Editorial assignment.","review_state":"not_assessed","coverage":"partial","record_ids":[]},"institutional decisions":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"Editorial assignment.","review_state":"not_assessed","coverage":"partial","record_ids":[]}},"fields":{"actors[]":{"state":"value_present","value":{"kind":"record_fields","fields":{"developer":"Tencent Healthcare (Shenzhen) Co., Ltd. (腾讯医疗健康（深圳）有限公司)","deployer":"Tencent Healthcare (Shenzhen) (prospective randomized trial with 296 patients at two centers)"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["developer","deployer"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"actors[].ownership_control":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"ai_contribution":{"state":"value_present","value":{"kind":"record_fields","fields":{"ai_role":{"status":"assessed","statement":"The randomized trial compared two groups of patients to test the software for superiority, so it isolates the software's part. The report does not say how each group used the software. Group B is presumed to have used it in the first examination because CMDE found its result superior. The trial was the maker's own."}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ai_role"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"ai_relationship":{"state":"value_present","value":{"kind":"record_fields","fields":{"category":"aggregate result","ai_role":{"status":"assessed","statement":"The randomized trial compared two groups of patients to test the software for superiority, so it isolates the software's part. The report does not say how each group used the software. Group B is presumed to have used it in the first examination because CMDE found its result superior. The trial was the maker's own."}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ai_role","category"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"assessments[].alternatives":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"assessments[].assessor_date":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"assessments[].depth":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"assessments[].display_confidence":{"state":"value_present","value":{"kind":"structured","data":{"confidence":"high","evidence_word":"found","claim_status":"Found by a regulator","basis":"Sources: two independent regulatory documents. For the benefit itself, the cited sources include no independent study or report.","interpretation":"Existing display rule preserved; the richer outcome-specific confidence question still needs review."}},"provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"assessments[].rationale":{"state":"value_present","value":{"kind":"record_fields","fields":{"ratings":[{"group":"organizational","reason":"The gain was measured in the maker's pre-market trial, and the report gives no outcome of care and does not say how each group used the software."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ratings"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"assessments[].rubric_version":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"assessments[].status_basis":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"assessments[].target":{"state":"value_present","value":{"kind":"record_fields","fields":{"ratings":[{"group":"organizational","reason":"The gain was measured in the maker's pre-market trial, and the report gives no outcome of care and does not say how each group used the software."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ratings"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"availability":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"brief":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"case_kind":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"case_links[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"claims[].evidence_links":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"claims[].evidence_strength":{"state":"value_present","value":{"kind":"structured","data":{"answer":"Found by a regulator. Sources: two independent regulatory documents. For the benefit itself, the cited sources include no independent study or report.","evidence_word":"found","claim_status":"Found by a regulator"}},"provenance":{"kind":"source_review","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":["AIBD-1068-source-0001","AIBD-1068-source-0002","AIBD-1068-source-0003"],"reviewed_on":"2026-10-29"},"review_state":"reviewed","coverage":"complete","display":{"answer":"Found by a regulator. Sources: two independent regulatory documents. For the benefit itself, the cited sources include no independent study or report.","inferred":false}},"claims[].missingness":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"claims[].proposition":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"cross_border_flows[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"decisions[].action_outcome":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"institutional decisions"},"decisions[].grounds":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"institutional decisions"},"decisions[].institution_task":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"institutional decisions"},"decisions[].success_criterion":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"institutional decisions"},"deployment_stage":{"state":"value_present","value":{"kind":"structured","data":{"classification":"pilot","answer":"The system was used in a pilot. The maker's prospective randomized trial enrolled 296 patients at two centers before approval.","scope":"The period and activity described in the case."}},"provenance":{"kind":"source_review","basis":"Editorial assignment.","record_fields":["account","evidence"],"source_refs":["AIBD-1068-source-0001"],"reviewed_on":"2026-10-29"},"review_state":"reviewed","coverage":"complete","display":{"answer":"The system was used in a pilot. The maker's prospective randomized trial enrolled 296 patients at two centers before approval.","inferred":false}},"economics[].amount":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].costs[]":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].counterfactual":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].currency_price_basis":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].gross_net":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].measure_type":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].period_unit":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].realization":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].recipient_payer":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].return_payback":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"economics[].valuation_method":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"monetary observations"},"evaluations[].ai_uplift":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].comparator":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].design":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].effect":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].exposure":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].id":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].measurement_method":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].metric":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].reproduction_materials":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].setting_sample":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"evaluations[].uncertainty_limitations":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"evaluations"},"external_references[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"follow_up[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"human_oversight":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"id":{"state":"value_present","value":{"kind":"record_fields","fields":{"id":"AIBD-1068"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["id"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"infrastructure_dependencies[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"outcomes[].beneficiaries":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"outcomes[].beneficiary_count":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"outcomes[].benefit_type":{"state":"value_present","value":{"kind":"record_fields","fields":{"benefit_type":"Improved Task Accuracy"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["benefit_type"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"outcomes[].claim":{"state":"value_present","value":{"kind":"record_fields","fields":{"account":"Tencent Healthcare (Shenzhen) built MY-CJ-01, software that uses deep learning to mark suspected polyps in real time during colonoscopy. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the company's application for Class III registration. The trial was the maker's own, a prospective randomized superiority trial at two centers that enrolled 296 patients and analyzed 265. CMDE reports that group B outperformed group A on first-pass polyp detection, with a lower 95% confidence bound of 13.67% for the difference. The polyp miss rate was 44.67% in group A and 23.39% in group B. The report does not say how each group used the software. Group B presumably used it in the first examination, since CMDE counted its advantage as the product's superiority. The polyp detection rate was 62.50% in group A and 63.57% in group B, and withdrawal took slightly longer with the software. On 18 May 2023, CMDE judged that “该产品的上市为适用人群带来的受益大于风险” (marketing the product brings its intended patients more benefit than risk). It recommended approval, which NMPA announced on 1 June 2023.","benefit_type":"Improved Task Accuracy"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["account","benefit_type"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"outcomes[].distribution":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"outcomes[].duration":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"outcomes[].id":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"outcomes[].stakeholder_group":{"state":"value_present","value":{"kind":"record_fields","fields":{"ratings":[{"group":"organizational","reason":"The gain was measured in the maker's pre-market trial, and the report gives no outcome of care and does not say how each group used the software."}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["ratings"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"outcomes[].status":{"state":"value_present","value":{"kind":"record_fields","fields":{"benefit_status":"intended"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["benefit_status"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"outcomes[].tradeoffs":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"outcomes[].unexpected":{"state":"value_present","value":{"kind":"record_fields","fields":{"unexpected":false,"purpose":"Tencent Healthcare (Shenzhen) built MY-CJ-01 to mark suspected polyps in real time in the video of adult colonoscopies for endoscopists."}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["unexpected","purpose"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"places[]":{"state":"value_present","value":{"kind":"record_fields","fields":{"location":"Two trial centers that the report does not name, for a registration in China","developer_country":"China","deployer_country":"China"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["location","developer_country","deployer_country"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"purpose":{"state":"value_present","value":{"kind":"record_fields","fields":{"purpose":"Tencent Healthcare (Shenzhen) built MY-CJ-01 to mark suspected polyps in real time in the video of adult colonoscopies for endoscopists."}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["purpose"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"record_dates":{"state":"value_present","value":{"kind":"record_fields","fields":{"date_observed":"2023-05-18","date_basis":"source publication","date_precision":"day","revisions":[{"date":"2026-11-01","change":"Added the record from the finding of the Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration.","source":"https://www.cmde.org.cn/directory/web/cmde/images/1686295172757009730.pdf","editor":"AIBD"}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["date_observed","date_basis","date_precision","revisions"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"replication.attempts[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"replication.conditions":{"state":"value_present","value":{"kind":"record_fields","fields":{"replication":{"produced_by":["The software took the video stream from the endoscope's image processor and marked suspected polyps with a deep learning algorithm on a separate video client.","Patients at two centers were randomized to two groups in a prospective superiority trial."],"must_hold":["Patients are adults having colonoscopy in a medical institution.","The endoscope is a specified model used in white light mode.","Endoscopists judge polyps from the images and the patient's condition and do not decide on the marks alone."],"echoes":[]}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["replication"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"revision_history[]":{"state":"value_present","value":{"kind":"record_fields","fields":{"revisions":[{"date":"2026-11-01","change":"Added the record from the finding of the Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration.","source":"https://www.cmde.org.cn/directory/web/cmde/images/1686295172757009730.pdf","editor":"AIBD"}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["revisions"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sector":{"state":"value_present","value":{"kind":"record_fields","fields":{"domain":"Healthcare"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["domain"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sources[].access_version":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"sources[].citation_locator":{"state":"value_present","value":{"kind":"record_fields","fields":{"evidence":[{"kind":"regulatory document","citation":"Center for Medical Device Evaluation (CMDE), National Medical Products Administration, China. 医疗器械产品注册技术审评报告：结肠息肉电子内窥镜图像辅助检测软件 (technical review report for the registration of colon polyp electronic endoscope image detection-aid software), acceptance no. CQZ2200455, applicant 腾讯医疗健康（深圳）有限公司. 18 May 2023. Section 三、临床评价概述 (clinical evaluation), pp. 6-7.","title":"医疗器械产品注册技术审评报告：结肠息肉电子内窥镜图像辅助检测软件（CQZ2200455）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1686295172757009730.pdf","date":"2023-05-18","written_by":"independent","quote":"A 组息肉漏检率为 44.67% (95%CI:39.07%~50.42%)，B 组息肉漏检率为23.39% (95%CI:18.92%~28.54%)"},{"kind":"regulatory document","citation":"Center for Medical Device Evaluation (CMDE), National Medical Products Administration, China. 医疗器械产品注册技术审评报告：结肠息肉电子内窥镜图像辅助检测软件 (technical review report for the registration of colon polyp electronic endoscope image detection-aid software), acceptance no. CQZ2200455, applicant 腾讯医疗健康（深圳）有限公司. 18 May 2023. Section 四、产品受益风险判定 (benefit-risk determination), CMDE's own judgment.","title":"医疗器械产品注册技术审评报告：结肠息肉电子内窥镜图像辅助检测软件（CQZ2200455）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1686295172757009730.pdf","date":"2023-05-18","written_by":"independent","quote":"根据申请人提供的申报资料，经综合评价，在目前认知水平上，认为该产品的上市为适用人群带来的受益大于风险。"},{"kind":"regulatory document","citation":"National Medical Products Administration (NMPA), China. Computer-aided Detection Software for Electronic Endoscope for Colon Polyps Approved for Marketing. NMPA English website, 1 June 2023.","title":"Computer-aided Detection Software for Electronic Endoscope for Colon Polyps Approved for Marketing","url":"https://english.nmpa.gov.cn/2023-06/01/c_940345.htm","date":"2023-06-01","written_by":"independent","quote":"Recently, the innovative product computer-aided detection software for electronic endoscope for colon polyps of Tencent Healthcare (Shenzhen) Co., Ltd. is approved by China NMPA.","supports_benefit":false}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sources[].id":{"state":"value_present","value":{"kind":"identifiers","identifiers":["AIBD-1068-source-0001","AIBD-1068-source-0002","AIBD-1068-source-0003"],"role":"Existing evidence items, in their original order"},"provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"complete"},"sources[].language":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"sources[].relationship":{"state":"value_present","value":{"kind":"record_fields","fields":{"evidence":[{"kind":"regulatory document","citation":"Center for Medical Device Evaluation (CMDE), National Medical Products Administration, China. 医疗器械产品注册技术审评报告：结肠息肉电子内窥镜图像辅助检测软件 (technical review report for the registration of colon polyp electronic endoscope image detection-aid software), acceptance no. CQZ2200455, applicant 腾讯医疗健康（深圳）有限公司. 18 May 2023. Section 三、临床评价概述 (clinical evaluation), pp. 6-7.","title":"医疗器械产品注册技术审评报告：结肠息肉电子内窥镜图像辅助检测软件（CQZ2200455）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1686295172757009730.pdf","date":"2023-05-18","written_by":"independent","quote":"A 组息肉漏检率为 44.67% (95%CI:39.07%~50.42%)，B 组息肉漏检率为23.39% (95%CI:18.92%~28.54%)"},{"kind":"regulatory document","citation":"Center for Medical Device Evaluation (CMDE), National Medical Products Administration, China. 医疗器械产品注册技术审评报告：结肠息肉电子内窥镜图像辅助检测软件 (technical review report for the registration of colon polyp electronic endoscope image detection-aid software), acceptance no. CQZ2200455, applicant 腾讯医疗健康（深圳）有限公司. 18 May 2023. Section 四、产品受益风险判定 (benefit-risk determination), CMDE's own judgment.","title":"医疗器械产品注册技术审评报告：结肠息肉电子内窥镜图像辅助检测软件（CQZ2200455）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1686295172757009730.pdf","date":"2023-05-18","written_by":"independent","quote":"根据申请人提供的申报资料，经综合评价，在目前认知水平上，认为该产品的上市为适用人群带来的受益大于风险。"},{"kind":"regulatory document","citation":"National Medical Products Administration (NMPA), China. Computer-aided Detection Software for Electronic Endoscope for Colon Polyps Approved for Marketing. NMPA English website, 1 June 2023.","title":"Computer-aided Detection Software for Electronic Endoscope for Colon Polyps Approved for Marketing","url":"https://english.nmpa.gov.cn/2023-06/01/c_940345.htm","date":"2023-06-01","written_by":"independent","quote":"Recently, the innovative product computer-aided detection software for electronic endoscope for colon polyps of Tencent Healthcare (Shenzhen) Co., Ltd. is approved by China NMPA.","supports_benefit":false}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sources[].upstream_sources":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"strategic_assessments[]":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"strategic assessments"},"summary":{"state":"value_present","value":{"kind":"record_fields","fields":{"summary":"China's CMDE found that first-pass polyp detection was superior in group B of Tencent's randomized MY-CJ-01 trial. The polyp miss rate was 23.39%, against 44.67% in group A.","account":"Tencent Healthcare (Shenzhen) built MY-CJ-01, software that uses deep learning to mark suspected polyps in real time during colonoscopy. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the company's application for Class III registration. The trial was the maker's own, a prospective randomized superiority trial at two centers that enrolled 296 patients and analyzed 265. CMDE reports that group B outperformed group A on first-pass polyp detection, with a lower 95% confidence bound of 13.67% for the difference. The polyp miss rate was 44.67% in group A and 23.39% in group B. The report does not say how each group used the software. Group B presumably used it in the first examination, since CMDE counted its advantage as the product's superiority. The polyp detection rate was 62.50% in group A and 63.57% in group B, and withdrawal took slightly longer with the software. On 18 May 2023, CMDE judged that “该产品的上市为适用人群带来的受益大于风险” (marketing the product brings its intended patients more benefit than risk). It recommended approval, which NMPA announced on 1 June 2023."}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["summary","account"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].autonomy_permissions":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].component_role":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].deployment_configuration":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].inputs_outputs":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].model_name":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"systems[].model_version":{"state":"value_present","value":{"kind":"record_fields","fields":{"model_version":"Release V2 (full version V2.0.0_build001)"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["model_version"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].product_name":{"state":"value_present","value":{"kind":"record_fields","fields":{"system":"MY-CJ-01 (结肠息肉电子内窥镜图像辅助检测软件)"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["system"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"systems[].provider":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"taxonomy_crosswalks[]":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"title":{"state":"value_present","value":{"kind":"record_fields","fields":{"title":"China's CMDE finds that Tencent's MY-CJ-01 software raised first-pass polyp detection in the maker's randomized colonoscopy trial","headline":"*MY-CJ-01* raised first-pass polyp detection in Tencent's trial"}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["title","headline"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"version":{"state":"value_present","value":{"kind":"identifiers","identifiers":["5657276a7ff754be26fb1cf82f443b64763c40ed18ce8f927a464f3efa907d58"],"role":"SHA-256 of the complete public record and its assessments"},"provenance":{"kind":"curatorial","basis":"SHA-256 of the public record, its assessments, and its displayed answers and notes, excluding its own identifier and the derived coverage summary.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"complete"},"workflow":{"state":"value_present","value":{"kind":"record_fields","fields":{"account":"Tencent Healthcare (Shenzhen) built MY-CJ-01, software that uses deep learning to mark suspected polyps in real time during colonoscopy. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the company's application for Class III registration. The trial was the maker's own, a prospective randomized superiority trial at two centers that enrolled 296 patients and analyzed 265. CMDE reports that group B outperformed group A on first-pass polyp detection, with a lower 95% confidence bound of 13.67% for the difference. The polyp miss rate was 44.67% in group A and 23.39% in group B. The report does not say how each group used the software. Group B presumably used it in the first examination, since CMDE counted its advantage as the product's superiority. The polyp detection rate was 62.50% in group A and 63.57% in group B, and withdrawal took slightly longer with the software. On 18 May 2023, CMDE judged that “该产品的上市为适用人群带来的受益大于风险” (marketing the product brings its intended patients more benefit than risk). It recommended approval, which NMPA announced on 1 June 2023.","replication":{"produced_by":["The software took the video stream from the endoscope's image processor and marked suspected polyps with a deep learning algorithm on a separate video client.","Patients at two centers were randomized to two groups in a prospective superiority trial."],"must_hold":["Patients are adults having colonoscopy in a medical institution.","The endoscope is a specified model used in white light mode.","Endoscopists judge polyps from the images and the patient's condition and do not decide on the marks alone."],"echoes":[]}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["account","replication"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"}},"summary":{"total":91,"addressed":91,"known":29,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":27,"review_not_assessed":62,"not_assessed":0,"complete":false,"by_state":{"value_present":29,"not_reported":0,"unresolved":62,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"4883d0a54e0821b03c9a50a798e48f246cf1c5c4a0368ada83564fb5ee4a4a1d"}