{"id":"AIBD-1087","title":"China's CMDE finds that Infervision's IR-CT-AO flagged aortic dissection with 87.83% sensitivity and 97.64% specificity in the maker's trial","summary":"In the maker's prospective trial of 485 subjects that China's CMDE reviewed, Infervision's IR-CT-AO flagged aortic dissection with 87.83% sensitivity and 97.64% specificity.","date_observed":"2024-08-05","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Infervision Medical Technology built IR-CT-AO, software that uses deep learning to segment and name the aorta on CT angiography and flag suspected aortic dissection for triage. It is meant for adults with risk factors, pain or signs that suggest dissection. 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, multicenter, single-arm study of 485 subjects. Three senior physicians with more than 10 years of cardiothoracic imaging experience read each case independently, and the majority view was the reference. Sensitivity was 87.83% (95% CI 82.30% to 92.13%) and specificity 97.64% (95% CI 95.19% to 98.95%), both above targets of 80%. The report gives the software's triage time as 130 seconds, and no software failure or adverse event occurred. On 5 August 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 report names neither the trial sites nor their number. 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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造影图像辅助评估软件（CQZ2302385）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1743990567461064830.pdf","date":"2024-08-05","written_by":"independent","quote":"主动脉夹层分诊的灵敏度为 87.83%， 95%置信区间为[82.30%， 92.13%]， 下限高于目标值 80%"},{"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造影图像辅助评估软件 (technical review report for the registration of aortic dissection CT angiography image assessment-aid software), acceptance no. CQZ2302385, applicant 推想医疗科技股份有限公司. 5 August 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造影图像辅助评估软件（CQZ2302385）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1743990567461064830.pdf","date":"2024-08-05","written_by":"independent","quote":"综上，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 and named the aorta on CT angiography with deep learning and flagged suspected aortic dissection.","Three physicians with more than 10 years of cardiothoracic imaging experience read each case independently, and the majority view served as the reference."],"must_hold":["Patients are adults with risk factors, pain or signs that suggest aortic dissection.","CT angiography slices are 2 mm or thinner, as in the trial.","Trained physicians use the prompt and do not base a clinical decision on it alone."],"echoes":[]},"paired_incident":null,"headline":"*IR-CT-AO* flagged aortic dissections in a prospective trial in China","metric":"87.83% sensitivity and 97.64% specificity","comparator":{"against":"Preset targets, with a three-physician expert panel's reading as the reference","before":"Targets of 80% for sensitivity and for specificity","after":"87.83% sensitivity and 97.64% specificity","basis":"measured","quote":"主动脉夹层分诊的灵敏度为 87.83%，95%置信区间为[82.30%，92.13%]，下限高于目标值 80%；特异度为 97.64%，95%置信区间为[95.19%，98.95%], 下限高于目标值 80%","url":"https://www.cmde.org.cn/directory/web/cmde/images/1743990567461064830.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The accuracy 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/1743990567461064830.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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