{"id":"AIBD-1084","title":"China's CMDE finds that uAI-AorticDissection flagged aortic dissection on CT angiography with 99.46% sensitivity in the maker's trial","summary":"In the maker's retrospective trial that China's CMDE reviewed, uAI-AorticDissection flagged aortic dissection with 99.46% sensitivity and 98.45% specificity against an expert panel.","date_observed":"2024-11-04","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Shanghai United Imaging Intelligence built uAI-AorticDissection, software that uses deep learning on aortic CT angiography of adults to flag suspected acute aortic dissection for triage. 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 retrospective, multicenter, single-arm study of 380 subjects at three institutions. An expert panel's reading served as the reference. The trial excluded patients with aortic ulcer, intramural hematoma, aneurysm, rupture or earlier aortic surgery or endovascular treatment. Case-level sensitivity was 99.46% (95% CI 96.99% to 99.90%) and specificity 98.45% (95% CI 95.55% to 99.47%). Both lower bounds exceeded the protocol's targets, which the report does not state. The software took 33.27 seconds per case on average, and no device defect occurred. On 4 November 2024, 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, so the prompts guided no care. 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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：主动脉夹层CT血管造影图像辅助分诊软件（CQZ2400640）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1732498238794063154.pdf","date":"2024-11-04","written_by":"independent","quote":"AI软件分诊主动脉夹层患者的灵敏度和特异度分别为99.46%(95%CI: 96.99%,99.90%)和98.45%(95%CI: 95.55%, 99.47%)，95%置信区间下限均高于目标值"},{"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：主动脉夹层CT血管造影图像辅助分诊软件 (technical review report for the registration of aortic dissection CT angiography image triage-aid software), acceptance no. CQZ2400640, applicant 上海联影智能医疗科技有限公司. 4 November 2024. 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：主动脉夹层CT血管造影图像辅助分诊软件（CQZ2400640）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1732498238794063154.pdf","date":"2024-11-04","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 analyzed adult aortic CT angiography with deep learning and gave a triage prompt for suspected acute aortic dissection.","An expert panel's reading served as the reference standard."],"must_hold":["Images are chest or chest-abdomen CT angiography with slices thinner than 1.3 mm, as in the trial.","The evidence covers patients without aortic ulcer, intramural hematoma, aneurysm, rupture or earlier aortic treatment, whom the trial excluded.","Trained physicians use the prompt and do not base a clinical decision on it alone."],"echoes":[]},"paired_incident":null,"headline":"*uAI-AorticDissection* flagged aortic dissections in China's review","metric":"99.46% sensitivity and 98.45% specificity","comparator":{"against":"Targets set in the trial protocol, with an expert panel's reading as the reference","before":"Protocol targets that the report does not state","after":"99.46% sensitivity and 98.45% specificity","basis":"measured","quote":"以专家组阅片结果为参考标准，软件分诊主动脉夹层患者的灵敏度（病例层面）为99.46%(95%CI: 96.99%, 99.90%)，软件分诊主动脉夹层患者的特异度（病例层面）为98.45%(95%CI: 95.55%, 99.47%)，二者的95%CI的下限均高于方案设定目标值。","url":"https://www.cmde.org.cn/directory/web/cmde/images/1732498238794063154.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The accuracy 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/1732498238794063154.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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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：主动脉夹层CT血管造影图像辅助分诊软件（CQZ2400640）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1732498238794063154.pdf","date":"2024-11-04","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-1084-source-0001","AIBD-1084-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：主动脉夹层CT血管造影图像辅助分诊软件 (technical review report for the registration of aortic dissection CT angiography image triage-aid software), acceptance no. 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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 retrospective, multicenter, single-arm study of 380 subjects at three institutions. An expert panel's reading served as the reference. The trial excluded patients with aortic ulcer, intramural hematoma, aneurysm, rupture or earlier aortic surgery or endovascular treatment. Case-level sensitivity was 99.46% (95% CI 96.99% to 99.90%) and specificity 98.45% (95% CI 95.55% to 99.47%). Both lower bounds exceeded the protocol's targets, which the report does not state. The software took 33.27 seconds per case on average, and no device defect occurred. On 4 November 2024, 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, so the prompts guided no care. 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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 retrospective, multicenter, single-arm study of 380 subjects at three institutions. An expert panel's reading served as the reference. The trial excluded patients with aortic ulcer, intramural hematoma, aneurysm, rupture or earlier aortic surgery or endovascular treatment. Case-level sensitivity was 99.46% (95% CI 96.99% to 99.90%) and specificity 98.45% (95% CI 95.55% to 99.47%). Both lower bounds exceeded the protocol's targets, which the report does not state. The software took 33.27 seconds per case on average, and no device defect occurred. On 4 November 2024, 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, so the prompts guided no care. 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