{"id":"AIBD-0960","title":"China's CMDE finds that sonographers using ITS-200 identified more malignant thyroid nodules in the maker's randomized trial","summary":"In the maker's randomized trial that China's CMDE reviewed, sonographers using ITS-200 identified malignant thyroid nodules with 97.33% sensitivity, against 79.30% without it.","date_observed":"2025-03-06","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Maide Intelligent Technology (Wuxi) built ITS-200, software whose deep learning module flags suspected malignancy in thyroid nodules of 5 mm or more. The sonographer first outlines each nodule by hand on an ultrasound image. 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 controlled trial at five sites with surgical pathology as the reference. It enrolled 931 subjects, and 763 with paraffin pathology entered the main analysis. Nodule-level sensitivity was 97.33% with the software and 79.30% without, a difference of 18.03% (95% CI 14.57% to 21.61%). Case-level specificity was 94.19% against 75.93%. No adverse event was related to the device. On 6 March 2025, CMDE concluded from the applicant's file that “该产品的上市为适用人群带来的受益大于风险” (putting the product on the market brings the intended population benefits that outweigh the risks). It recommended approval. The report gives the same figures for the software alone as for the assisted sonographers. It does not say whether the prompts changed any patient's care.","category":"aggregate result","unexpected":false,"purpose":"Maide Intelligent Technology (Wuxi) built ITS-200 to give sonographers a suspected-malignancy prompt for thyroid nodules of 5 mm or more that they outline on ultrasound images.","system":"ITS-200 (甲状腺结节超声影像辅助诊断软件)","model_version":"Release 1","developer":"Maide Intelligent Technology (Wuxi) Co., Ltd. (脉得智能科技（无锡）有限公司)","deployer":"Maide Intelligent Technology (Wuxi) (prospective randomized trial with 931 subjects at five sites)","location":"Five trial sites 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"],"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 does not say whether the prompts changed any patient's care."}],"ai_role":{"status":"assessed","statement":"The randomized trial compared sonographers with and without the software against surgical pathology, so the gain is attributed to the software. The trial was the maker's own. The report gives identical sensitivity and specificity for the software alone and for the assisted sonographers."},"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：甲状腺结节超声影像辅助诊断软件 (technical review report for the registration of thyroid nodule ultrasound image diagnosis-aid software), acceptance no. CQZ2400633, applicant 脉得智能科技（无锡）有限公司. 6 March 2025. Section 三、临床评价概述 (clinical evaluation).","title":"医疗器械产品注册技术审评报告：甲状腺结节超声影像辅助诊断软件（CQZ2400633）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1742452535587010664.pdf","date":"2025-03-06","written_by":"independent","quote":"临床试验结果显示，主要评价指标甲状腺结节良恶性识别的结节水平的灵敏度 FAS 集试验组为 97.33%，对照组为79.30%， 两组差值为 18.03%， 95%置信区间为(14.57%， 21.61%)，95%置信区间下限大于优效界值 0。"},{"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：甲状腺结节超声影像辅助诊断软件 (technical review report for the registration of thyroid nodule ultrasound image diagnosis-aid software), acceptance no. CQZ2400633, applicant 脉得智能科技（无锡）有限公司. 6 March 2025. Section 四、产品受益风险判定 (benefit-risk determination), CMDE's own judgment of benefit and risk.","title":"医疗器械产品注册技术审评报告：甲状腺结节超声影像辅助诊断软件（CQZ2400633）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1742452535587010664.pdf","date":"2025-03-06","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。"}],"replication":{"produced_by":["A sonographer outlined each nodule by hand on a grayscale ultrasound image imported into the software.","The software's deep learning module then gave a suspected-malignancy prompt for the outlined nodule."],"must_hold":["Nodules are 5 mm or larger, in patients without prior thyroid nodule surgery, ablation, radiotherapy or chemotherapy.","Images come from the specified ultrasound devices and probes.","Sonographers make the final judgment, and the prompt does not replace a biopsy."],"echoes":[]},"paired_incident":null,"headline":"*ITS-200* helped sonographers spot more malignant thyroid nodules","metric":"97.33% sensitivity, against 79.30% without it","comparator":{"against":"Sonographers assessing nodules without the software in the same randomized trial, with surgical pathology as the reference","before":"79.30% nodule-level sensitivity","after":"97.33% nodule-level sensitivity","basis":"measured","quote":"临床试验结果显示，主要评价指标甲状腺结节良恶性识别的结节水平的灵敏度 FAS 集试验组为 97.33%，对照组为79.30%， 两组差值为 18.03%， 95%置信区间为(14.57%， 21.61%)，95%置信区间下限大于优效界值 0。","url":"https://www.cmde.org.cn/directory/web/cmde/images/1742452535587010664.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/1742452535587010664.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. The cited evidence includes no independent study or report.","case_jurisdictions":["China"],"profile":{"case_id":"AIBD-0960","catalog_version":"1.0.0","source_fingerprint":"8b2d93bf4f7dd606039332f1edfc881f702650ac60daae0a1bc4a3c44e9b47d2","collection_refs":[{"collection_id":"aibd","version":"2026-10-31"},{"collection_id":"querist","version":"2026-10-25"}],"source_ids":["AIBD-0960-source-0001","AIBD-0960-source-0002"],"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":"Maide Intelligent Technology (Wuxi) Co., Ltd. (脉得智能科技（无锡）有限公司)","deployer":"Maide Intelligent Technology (Wuxi) (prospective randomized trial with 931 subjects at five sites)"}},"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 sonographers with and without the software against surgical pathology, so the gain is attributed to the software. The trial was the maker's own. The report gives identical sensitivity and specificity for the software alone and for the assisted sonographers."}}},"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 sonographers with and without the software against surgical pathology, so the gain is attributed to the software. The trial was the maker's own. The report gives identical sensitivity and specificity for the software alone and for the assisted sonographers."}}},"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: one independent regulatory document. The cited evidence includes 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 does not say whether the prompts changed any patient's care."}]}},"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 does not say whether the prompts changed any patient's care."}]}},"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: one independent regulatory document. The cited evidence includes 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-0960-source-0001","AIBD-0960-source-0002"],"reviewed_on":"2026-10-29"},"review_state":"reviewed","coverage":"complete","display":{"answer":"Found by a regulator. Sources: one independent regulatory document. The cited evidence includes 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 931 subjects at five sites 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-0960-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 931 subjects at five sites 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-0960"}},"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":"Maide Intelligent Technology (Wuxi) built ITS-200, software whose deep learning module flags suspected malignancy in thyroid nodules of 5 mm or more. The sonographer first outlines each nodule by hand on an ultrasound image. 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 controlled trial at five sites with surgical pathology as the reference. It enrolled 931 subjects, and 763 with paraffin pathology entered the main analysis. Nodule-level sensitivity was 97.33% with the software and 79.30% without, a difference of 18.03% (95% CI 14.57% to 21.61%). Case-level specificity was 94.19% against 75.93%. No adverse event was related to the device. On 6 March 2025, CMDE concluded from the applicant's file that “该产品的上市为适用人群带来的受益大于风险” (putting the product on the market brings the intended population benefits that outweigh the risks). It recommended approval. The report gives the same figures for the software alone as for the assisted sonographers. It does not say whether the prompts changed any patient's care.","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 does not say whether the prompts changed any patient's care."}]}},"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":"Maide Intelligent Technology (Wuxi) built ITS-200 to give sonographers a suspected-malignancy prompt for thyroid nodules of 5 mm or more that they outline on ultrasound images."}},"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":"Five trial sites 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":"Maide Intelligent Technology (Wuxi) built ITS-200 to give sonographers a suspected-malignancy prompt for thyroid nodules of 5 mm or more that they outline on ultrasound images."}},"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":"2025-03-06","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/1742452535587010664.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":["A sonographer outlined each nodule by hand on a grayscale ultrasound image imported into the software.","The software's deep learning module then gave a suspected-malignancy prompt for the outlined nodule."],"must_hold":["Nodules are 5 mm or larger, in patients without prior thyroid nodule surgery, ablation, radiotherapy or chemotherapy.","Images come from the specified ultrasound devices and probes.","Sonographers make the final judgment, and the prompt does not replace a biopsy."],"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/1742452535587010664.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：甲状腺结节超声影像辅助诊断软件 (technical review report for the registration of thyroid nodule ultrasound image diagnosis-aid software), acceptance no. CQZ2400633, applicant 脉得智能科技（无锡）有限公司. 6 March 2025. Section 三、临床评价概述 (clinical evaluation).","title":"医疗器械产品注册技术审评报告：甲状腺结节超声影像辅助诊断软件（CQZ2400633）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1742452535587010664.pdf","date":"2025-03-06","written_by":"independent","quote":"临床试验结果显示，主要评价指标甲状腺结节良恶性识别的结节水平的灵敏度 FAS 集试验组为 97.33%，对照组为79.30%， 两组差值为 18.03%， 95%置信区间为(14.57%， 21.61%)，95%置信区间下限大于优效界值 0。"},{"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：甲状腺结节超声影像辅助诊断软件 (technical review report for the registration of thyroid nodule ultrasound image diagnosis-aid software), acceptance no. CQZ2400633, applicant 脉得智能科技（无锡）有限公司. 6 March 2025. Section 四、产品受益风险判定 (benefit-risk determination), CMDE's own judgment of benefit and risk.","title":"医疗器械产品注册技术审评报告：甲状腺结节超声影像辅助诊断软件（CQZ2400633）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1742452535587010664.pdf","date":"2025-03-06","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。"}]}},"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-0960-source-0001","AIBD-0960-source-0002"],"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：甲状腺结节超声影像辅助诊断软件 (technical review report for the registration of thyroid nodule ultrasound image diagnosis-aid software), acceptance no. CQZ2400633, applicant 脉得智能科技（无锡）有限公司. 6 March 2025. Section 三、临床评价概述 (clinical evaluation).","title":"医疗器械产品注册技术审评报告：甲状腺结节超声影像辅助诊断软件（CQZ2400633）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1742452535587010664.pdf","date":"2025-03-06","written_by":"independent","quote":"临床试验结果显示，主要评价指标甲状腺结节良恶性识别的结节水平的灵敏度 FAS 集试验组为 97.33%，对照组为79.30%， 两组差值为 18.03%， 95%置信区间为(14.57%， 21.61%)，95%置信区间下限大于优效界值 0。"},{"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：甲状腺结节超声影像辅助诊断软件 (technical review report for the registration of thyroid nodule ultrasound image diagnosis-aid software), acceptance no. CQZ2400633, applicant 脉得智能科技（无锡）有限公司. 6 March 2025. Section 四、产品受益风险判定 (benefit-risk determination), CMDE's own judgment of benefit and risk.","title":"医疗器械产品注册技术审评报告：甲状腺结节超声影像辅助诊断软件（CQZ2400633）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1742452535587010664.pdf","date":"2025-03-06","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。"}]}},"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":"In the maker's randomized trial that China's CMDE reviewed, sonographers using ITS-200 identified malignant thyroid nodules with 97.33% sensitivity, against 79.30% without it.","account":"Maide Intelligent Technology (Wuxi) built ITS-200, software whose deep learning module flags suspected malignancy in thyroid nodules of 5 mm or more. The sonographer first outlines each nodule by hand on an ultrasound image. 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 controlled trial at five sites with surgical pathology as the reference. It enrolled 931 subjects, and 763 with paraffin pathology entered the main analysis. Nodule-level sensitivity was 97.33% with the software and 79.30% without, a difference of 18.03% (95% CI 14.57% to 21.61%). Case-level specificity was 94.19% against 75.93%. No adverse event was related to the device. On 6 March 2025, CMDE concluded from the applicant's file that “该产品的上市为适用人群带来的受益大于风险” (putting the product on the market brings the intended population benefits that outweigh the risks). It recommended approval. The report gives the same figures for the software alone as for the assisted sonographers. It does not say whether the prompts changed any patient's care."}},"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 1"}},"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":"ITS-200 (甲状腺结节超声影像辅助诊断软件)"}},"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 sonographers using ITS-200 identified more malignant thyroid nodules in the maker's randomized trial","headline":"*ITS-200* helped sonographers spot more malignant thyroid nodules"}},"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":["422f13c62676e148746b2cff3d9615c1787a71856541ef3899e01c4dbeb3371e"],"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":"Maide Intelligent Technology (Wuxi) built ITS-200, software whose deep learning module flags suspected malignancy in thyroid nodules of 5 mm or more. The sonographer first outlines each nodule by hand on an ultrasound image. 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 controlled trial at five sites with surgical pathology as the reference. It enrolled 931 subjects, and 763 with paraffin pathology entered the main analysis. Nodule-level sensitivity was 97.33% with the software and 79.30% without, a difference of 18.03% (95% CI 14.57% to 21.61%). Case-level specificity was 94.19% against 75.93%. No adverse event was related to the device. On 6 March 2025, CMDE concluded from the applicant's file that “该产品的上市为适用人群带来的受益大于风险” (putting the product on the market brings the intended population benefits that outweigh the risks). It recommended approval. The report gives the same figures for the software alone as for the assisted sonographers. It does not say whether the prompts changed any patient's care.","replication":{"produced_by":["A sonographer outlined each nodule by hand on a grayscale ultrasound image imported into the software.","The software's deep learning module then gave a suspected-malignancy prompt for the outlined nodule."],"must_hold":["Nodules are 5 mm or larger, in patients without prior thyroid nodule surgery, ablation, radiotherapy or chemotherapy.","Images come from the specified ultrasound devices and probes.","Sonographers make the final judgment, and the prompt does not replace a biopsy."],"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":"3b96fe3738b97e1fa89144b60d774bfc534f179c7bbdf2ce6da079bb84741acf"}