{"id":"AIBD-1093","title":"China's CMDE finds that uAI-CT_CerebralPerfusion measured stroke volumes in close agreement with a marketed product in the maker's trial","summary":"In the maker's trial that China's CMDE reviewed, uAI-CT_CerebralPerfusion measured infarct core and penumbra volumes with ICCs of 0.96 and 0.83 against an already-marketed product.","date_observed":"2025-06-26","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Shanghai United Imaging Intelligence built uAI-CT_CerebralPerfusion, software that uses deep learning to segment and measure brain CT perfusion images. It helps trained doctors assess the volumes of the infarct core and the ischemic penumbra in adults with ischemic stroke. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the company's application for Class III registration. The company compared the software with an already-marketed product of the same kind, which the report does not name. The trial was the maker's own, a retrospective study of 446 cases at six institutions that measured agreement between the two products' volumes. The intraclass correlation was 0.96 (95% CI 0.95 to 0.97) for the infarct core and 0.83 (0.79 to 0.86) for the penumbra. Both lower bounds exceeded the target of 0.75. The Bland-Altman mean differences were -0.07 mL and -2.88 mL. On 26 June 2025, CMDE concluded that “该产品上市带来的受益大于风险” (the benefits of putting the product on the market outweigh the risks) and recommended approval. The trial used stored images, and the report gives no comparison with a clinical reference.","category":"aggregate result","unexpected":false,"purpose":"Shanghai United Imaging Intelligence built uAI-CT_CerebralPerfusion to help trained doctors assess infarct core and penumbra volumes on brain CT perfusion images of adults with ischemic stroke.","system":"uAI-CT_CerebralPerfusion (脑缺血CT灌注图像辅助评估软件)","model_version":"Release 1.1 (full version 1.1-0-0-56)","developer":"Shanghai United Imaging Intelligence Co., Ltd. (上海联影智能医疗科技有限公司)","deployer":"Shanghai United Imaging Intelligence (retrospective registration trial with 446 cases at six institutions)","location":"Six trial institutions 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.3","4.A.1.b.1"],"taxonomy_note":"The benefit is agreement with an already-marketed product of the same kind, and the trial did not test for a gain over that product.","registry_ids":{},"ratings":[{"group":"organizational","depth":null,"reason":"The volumes were measured on stored images in the maker's pre-market trial, and no patient's care depended on them."}],"ai_role":{"status":"unassessed","statement":"The trial measured the software's volumes against those of an already-marketed product of the same kind. It did not compare doctors' assessments with and without the software. The trial was the maker's own. The report says that the product uses deep learning for segmentation and measurement."},"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：脑缺血CT灌注图像辅助评估软件 (technical review report for the registration of cerebral ischemia CT perfusion image assessment-aid software), acceptance no. CQZ2401663, applicant 上海联影智能医疗科技有限公司. 26 June 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：脑缺血CT灌注图像辅助评估软件（CQZ2401663）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1751851972285059301.pdf","date":"2025-06-26","written_by":"independent","quote":"主要评价指标软件评估梗死区体积 ICC一致性系数为 0.96 (95%CI: 0.95, 0.97)"},{"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：脑缺血CT灌注图像辅助评估软件 (technical review report for the registration of cerebral ischemia CT perfusion image assessment-aid software), acceptance no. CQZ2401663, applicant 上海联影智能医疗科技有限公司. 26 June 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：脑缺血CT灌注图像辅助评估软件（CQZ2401663）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1751851972285059301.pdf","date":"2025-06-26","written_by":"independent","quote":"经综合评价，认为该产品上市带来的受益大于风险，综合剩余风险可接受。"}],"replication":{"produced_by":["The software segmented brain CT perfusion images with deep learning and measured the volumes of the infarct core and the penumbra.","Its volumes were compared with those of an already-marketed product on the same 446 cases."],"must_hold":["Patients are adults with ischemic stroke who have brain CT perfusion images.","Trained doctors use the volumes and do not base a clinical decision on the software alone."],"echoes":[]},"paired_incident":null,"headline":"*uAI-CT_CerebralPerfusion* agreed with a marketed tool on stroke scans","metric":"ICCs of 0.96 and 0.83","comparator":{"against":"An already-marketed cerebral ischemia image assessment software of the same kind on the same cases, with a target ICC of 0.75 for the lower 95% confidence bound","before":"Target ICC of 0.75","after":"ICC 0.96 (95%CI: 0.95, 0.97) for the infarct core and 0.83 (95%CI: 0.79, 0.86) for the penumbra","basis":"measured","quote":"主要评价指标软件评估梗死区体积 ICC 一致性系数为 0.96 (95%CI: 0.95, 0.97)，软件评估缺血半暗带体积 ICC 一致性系数为 0.83 (95%CI: 0.79, 0.86)，二者 95%CI 的下限高于方案设定目标值 0.75","url":"https://www.cmde.org.cn/directory/web/cmde/images/1751851972285059301.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The agreement was measured on stored images in the maker's pre-market trial and guided no 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/1751851972285059301.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-1093","catalog_version":"1.0.0","source_fingerprint":"f4375a43066e00c22dab2cdaf2d641cba61707a425e0dcd42e01a8188730c7df","collection_refs":[{"collection_id":"aibd","version":"2026-10-31"},{"collection_id":"querist","version":"2026-10-25"}],"source_ids":["AIBD-1093-source-0001","AIBD-1093-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":"Shanghai United Imaging Intelligence Co., Ltd. (上海联影智能医疗科技有限公司)","deployer":"Shanghai United Imaging Intelligence (retrospective registration trial with 446 cases at six institutions)"}},"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":"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_relationship":{"state":"value_present","value":{"kind":"record_fields","fields":{"category":"aggregate result","ai_role":{"status":"unassessed","statement":"The trial measured the software's volumes against those of an already-marketed product of the same kind. It did not compare doctors' assessments with and without the software. The trial was the maker's own. The report says that the product uses deep learning for segmentation and measurement."}}},"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 volumes were measured on stored images in the maker's pre-market trial, and no patient's care depended on them."}]}},"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 volumes were measured on stored images in the maker's pre-market trial, and no patient's care depended on them."}]}},"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-1093-source-0001","AIBD-1093-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":"laboratory test","answer":"The system was tested in a laboratory. The maker's retrospective trial used stored CT perfusion images of 446 cases from six institutions 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-1093-source-0001"],"reviewed_on":"2026-10-29"},"review_state":"reviewed","coverage":"complete","display":{"answer":"The system was tested in a laboratory. The maker's retrospective trial used stored CT perfusion images of 446 cases from six institutions 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-1093"}},"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","taxonomy_note":"The benefit is agreement with an already-marketed product of the same kind, and the trial did not test for a gain over that product."}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["benefit_type","taxonomy_note"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"outcomes[].claim":{"state":"value_present","value":{"kind":"record_fields","fields":{"account":"Shanghai United Imaging Intelligence built uAI-CT_CerebralPerfusion, software that uses deep learning to segment and measure brain CT perfusion images. It helps trained doctors assess the volumes of the infarct core and the ischemic penumbra in adults with ischemic stroke. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the company's application for Class III registration. The company compared the software with an already-marketed product of the same kind, which the report does not name. The trial was the maker's own, a retrospective study of 446 cases at six institutions that measured agreement between the two products' volumes. The intraclass correlation was 0.96 (95% CI 0.95 to 0.97) for the infarct core and 0.83 (0.79 to 0.86) for the penumbra. Both lower bounds exceeded the target of 0.75. The Bland-Altman mean differences were -0.07 mL and -2.88 mL. On 26 June 2025, CMDE concluded that “该产品上市带来的受益大于风险” (the benefits of putting the product on the market outweigh the risks) and recommended approval. The trial used stored images, and the report gives no comparison with a clinical reference.","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 volumes were measured on stored images in the maker's pre-market trial, and no patient's care depended on them."}]}},"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":"Shanghai United Imaging Intelligence built uAI-CT_CerebralPerfusion to help trained doctors assess infarct core and penumbra volumes on brain CT perfusion images of adults with ischemic stroke."}},"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":"Six trial institutions 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":"Shanghai United Imaging Intelligence built uAI-CT_CerebralPerfusion to help trained doctors assess infarct core and penumbra volumes on brain CT perfusion images of adults with ischemic stroke."}},"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":"2025-06-26","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/1751851972285059301.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 segmented brain CT perfusion images with deep learning and measured the volumes of the infarct core and the penumbra.","Its volumes were compared with those of an already-marketed product on the same 446 cases."],"must_hold":["Patients are adults with ischemic stroke who have brain CT perfusion images.","Trained doctors use the volumes and do not base a clinical decision on the software 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/1751851972285059301.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：脑缺血CT灌注图像辅助评估软件 (technical review report for the registration of cerebral ischemia CT perfusion image assessment-aid software), acceptance no. CQZ2401663, applicant 上海联影智能医疗科技有限公司. 26 June 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：脑缺血CT灌注图像辅助评估软件（CQZ2401663）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1751851972285059301.pdf","date":"2025-06-26","written_by":"independent","quote":"主要评价指标软件评估梗死区体积 ICC一致性系数为 0.96 (95%CI: 0.95, 0.97)"},{"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：脑缺血CT灌注图像辅助评估软件 (technical review report for the registration of cerebral ischemia CT perfusion image assessment-aid software), acceptance no. CQZ2401663, applicant 上海联影智能医疗科技有限公司. 26 June 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：脑缺血CT灌注图像辅助评估软件（CQZ2401663）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1751851972285059301.pdf","date":"2025-06-26","written_by":"independent","quote":"经综合评价，认为该产品上市带来的受益大于风险，综合剩余风险可接受。"}]}},"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-1093-source-0001","AIBD-1093-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：脑缺血CT灌注图像辅助评估软件 (technical review report for the registration of cerebral ischemia CT perfusion image assessment-aid software), acceptance no. CQZ2401663, applicant 上海联影智能医疗科技有限公司. 26 June 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：脑缺血CT灌注图像辅助评估软件（CQZ2401663）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1751851972285059301.pdf","date":"2025-06-26","written_by":"independent","quote":"主要评价指标软件评估梗死区体积 ICC一致性系数为 0.96 (95%CI: 0.95, 0.97)"},{"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：脑缺血CT灌注图像辅助评估软件 (technical review report for the registration of cerebral ischemia CT perfusion image assessment-aid software), acceptance no. CQZ2401663, applicant 上海联影智能医疗科技有限公司. 26 June 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：脑缺血CT灌注图像辅助评估软件（CQZ2401663）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1751851972285059301.pdf","date":"2025-06-26","written_by":"independent","quote":"经综合评价，认为该产品上市带来的受益大于风险，综合剩余风险可接受。"}]}},"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 trial that China's CMDE reviewed, uAI-CT_CerebralPerfusion measured infarct core and penumbra volumes with ICCs of 0.96 and 0.83 against an already-marketed product.","account":"Shanghai United Imaging Intelligence built uAI-CT_CerebralPerfusion, software that uses deep learning to segment and measure brain CT perfusion images. It helps trained doctors assess the volumes of the infarct core and the ischemic penumbra in adults with ischemic stroke. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the company's application for Class III registration. The company compared the software with an already-marketed product of the same kind, which the report does not name. The trial was the maker's own, a retrospective study of 446 cases at six institutions that measured agreement between the two products' volumes. The intraclass correlation was 0.96 (95% CI 0.95 to 0.97) for the infarct core and 0.83 (0.79 to 0.86) for the penumbra. Both lower bounds exceeded the target of 0.75. The Bland-Altman mean differences were -0.07 mL and -2.88 mL. On 26 June 2025, CMDE concluded that “该产品上市带来的受益大于风险” (the benefits of putting the product on the market outweigh the risks) and recommended approval. The trial used stored images, and the report gives no comparison with a clinical reference."}},"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 1.1 (full version 1.1-0-0-56)"}},"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":"uAI-CT_CerebralPerfusion (脑缺血CT灌注图像辅助评估软件)"}},"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 uAI-CT_CerebralPerfusion measured stroke volumes in close agreement with a marketed product in the maker's trial","headline":"*uAI-CT_CerebralPerfusion* agreed with a marketed tool on stroke scans"}},"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":["77c063f168f7710726bb7be82ed178e20e7631b80c82b38a4e1de47c253abe1a"],"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":"Shanghai United Imaging Intelligence built uAI-CT_CerebralPerfusion, software that uses deep learning to segment and measure brain CT perfusion images. It helps trained doctors assess the volumes of the infarct core and the ischemic penumbra in adults with ischemic stroke. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the company's application for Class III registration. The company compared the software with an already-marketed product of the same kind, which the report does not name. The trial was the maker's own, a retrospective study of 446 cases at six institutions that measured agreement between the two products' volumes. The intraclass correlation was 0.96 (95% CI 0.95 to 0.97) for the infarct core and 0.83 (0.79 to 0.86) for the penumbra. Both lower bounds exceeded the target of 0.75. The Bland-Altman mean differences were -0.07 mL and -2.88 mL. On 26 June 2025, CMDE concluded that “该产品上市带来的受益大于风险” (the benefits of putting the product on the market outweigh the risks) and recommended approval. The trial used stored images, and the report gives no comparison with a clinical reference.","replication":{"produced_by":["The software segmented brain CT perfusion images with deep learning and measured the volumes of the infarct core and the penumbra.","Its volumes were compared with those of an already-marketed product on the same 446 cases."],"must_hold":["Patients are adults with ischemic stroke who have brain CT perfusion images.","Trained doctors use the volumes and do not base a clinical decision on the software 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":28,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":26,"review_not_assessed":63,"not_assessed":0,"complete":false,"by_state":{"value_present":28,"not_reported":0,"unresolved":63,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"9d269f8cbd3b56971bcb2d6c4dde9515e4e7135069cb8410374de6c7d445d4b6"}