{"id":"AIBD-1088","title":"China's CMDE finds that AneurDoc flagged suspected head and neck aneurysms on CT angiograms with 95.42% sensitivity in the maker's trial","summary":"In the maker's trial that China's CMDE reviewed, AneurDoc flagged suspected head and neck aneurysms with 95.42% sensitivity and 96.34% specificity against an expert panel.","date_observed":"2023-11-07","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Yukun (Beijing) Network Technology built AneurDoc, software that uses deep learning to detect visible aneurysms on head and neck CT angiograms. It helps trained doctors triage scans for intracranial aneurysms of 3 mm or more. 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 study of 486 cases with an expert panel's reading as the reference. The report names the General Hospital of the PLA Northern Theater Command and Huangshi Central Hospital as trial sites. Case-level sensitivity was 95.42% (95% CI 91.95% to 97.69%) and specificity 96.34% (93.17% to 98.31%). Both lower bounds exceeded the target of 90%. The software took 4.55 minutes on average to reach a result, against 10.00 minutes for the expert panel. On 7 November 2023, 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. 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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：颅内动脉瘤CT血管造影图像辅助分诊软件（CQZ2300190）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1743665461431073055.pdf","date":"2023-11-07","written_by":"independent","quote":"FAS 集的试验产品检出疑似头颈血管动脉瘤病例水平灵敏度为 95.42% （95%CI： 91.95%,97.69%）"},{"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：颅内动脉瘤CT血管造影图像辅助分诊软件 (technical review report for the registration of intracranial aneurysm CT angiography image triage-aid software), acceptance no. CQZ2300190, applicant 语坤（北京）网络科技有限公司. 7 November 2023. Section 四、产品收益风险判定 (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：颅内动脉瘤CT血管造影图像辅助分诊软件（CQZ2300190）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1743665461431073055.pdf","date":"2023-11-07","written_by":"independent","quote":"经综合评价，在当前认知水平上，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 reconstructed head and neck CT angiography images and used deep learning to detect visible aneurysms.","It produced automated text and table reports for doctors to assess.","An expert panel's reading served as the reference standard."],"must_hold":["The images are head and neck CT angiograms.","The software triages for intracranial aneurysms of 3 mm or more.","Trained doctors use the results and do not base a clinical decision on the software alone."],"echoes":[]},"paired_incident":null,"headline":"*AneurDoc* flagged aneurysms on CT angiograms in China's review","metric":"95.42% sensitivity and 96.34% specificity","comparator":{"against":"A target of 90% for the lower 95% confidence bounds of sensitivity and specificity, with an expert panel's reading as the reference","before":"Target of 90% for the lower confidence bounds","after":"Sensitivity 95.42% (95%CI：91.95%,97.69%) and specificity 96.34% (95%CI：93.17%,98.31%)","basis":"measured","quote":"特异度为 96.34%（95%CI：93.17%,98.31%），区间下限均大于目标值 90%，达到试验设计要求","url":"https://www.cmde.org.cn/directory/web/cmde/images/1743665461431073055.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 does not say that the software guided 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/1743665461431073055.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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It helps trained doctors triage scans for intracranial aneurysms of 3 mm or more. 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 study of 486 cases with an expert panel's reading as the reference. The report names the General Hospital of the PLA Northern Theater Command and Huangshi Central Hospital as trial sites. Case-level sensitivity was 95.42% (95% CI 91.95% to 97.69%) and specificity 96.34% (93.17% to 98.31%). Both lower bounds exceeded the target of 90%. The software took 4.55 minutes on average to reach a result, against 10.00 minutes for the expert panel. On 7 November 2023, 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. 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