{"id":"AIBD-1061","title":"China's CMDE finds that doctors reading brain MR angiograms with AIneurysm detected more aneurysms in the maker's trial","summary":"In the maker's trial that China's CMDE reviewed, AIneurysm raised doctors' lesion-level sensitivity for brain aneurysms on MR angiograms by 0.0698.","date_observed":"2024-08-13","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Fuying (Shanghai) Medical Technology built AIneurysm, deep learning software that marks suspected saccular aneurysms of 3 mm or more on brain MR angiograms. The Paper reports that a Fudan University team led its development. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the application for Class III registration. The trial was the maker's own, a retrospective, fully crossed multi-reader study of 484 analyzed cases from three centers. Each doctor read every case alone and with the software, at least four weeks apart. With the software, lesion-level sensitivity rose by 0.0698 (95% CI 0.0358 to 0.1037). Specificity met the non-inferiority margin. Median reading time was 2.02 minutes with the software and 1.47 minutes without. On 13 August 2024, CMDE concluded that “该产品上市带来的受益大于风险” (putting the product on the market brings benefits that outweigh the risks). It recommended approval. The doctors read stored images, so the software guided no care. The Fudan team told The Paper that the software cut reading time per case by 60%. 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The Paper reports that a Fudan University team led by Professor Geng Daoying developed the software.","deployer":"Fuying (Shanghai) Medical Technology (retrospective reader trial on 486 cases from three centers)","location":"Three trial centers 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":"Doctors read stored images in the maker's pre-market trial, and no patient's care depended on the software."}],"ai_role":{"status":"assessed","statement":"In a fully crossed design, every doctor read every case with and without the software, so the gain in sensitivity is attributed to the software. The trial was the maker's own. 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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：颅内动脉瘤磁共振图像辅助检测软件（CQZ2301701）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1724824253132010762.pdf","date":"2024-08-13","written_by":"independent","quote":"病灶水平下 AI 辅助阅片与单独阅片对动脉瘤检出灵敏度差值的 95%置信区间下限大于优效界值"},{"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：颅内动脉瘤磁共振图像辅助检测软件 (technical review report for the registration of intracranial aneurysm detection-aid software for magnetic resonance images), acceptance no. CQZ2301701, applicant 复影（上海）医疗科技有限公司. 13 August 2024. Benefit-risk determination and overall opinion, CMDE's own judgment of benefit and risk.","title":"医疗器械产品注册技术审评报告：颅内动脉瘤磁共振图像辅助检测软件（CQZ2301701）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1724824253132010762.pdf","date":"2024-08-13","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。"},{"kind":"news report","citation":"The Paper (澎湃新闻), republished by ifeng.com (凤凰网科技). 高校主导、临床医生牵头，这款软件获批三类医疗器械注册证 (Led by a university and clinicians, this software wins a Class III medical device registration certificate). 6 September 2024. The figures are the development team's statements to the reporter.","title":"高校主导、临床医生牵头，这款软件获批三类医疗器械注册证","url":"https://news.ifeng.com/c/8cf6NUaLjhW","date":"2024-09-06","written_by":"independent","quote":"颅内动脉瘤磁共振造影图像辅助检测软件提升动脉瘤检出率10%，诊断效能由82%提高到94%，每例阅片时间缩短60%","supports_benefit":false}],"replication":{"produced_by":["The software extracted the intracranial arteries from MR angiograms and marked suspected saccular aneurysms with deep learning.","Doctors could edit the marks and produce a text report."],"must_hold":["Images are brain MR angiograms, and aneurysms are 3 mm or larger.","Trained doctors read the images and do not base a clinical decision on the software alone."],"echoes":[]},"paired_incident":null,"headline":"*AIneurysm* helped doctors find more brain aneurysms on MR scans","metric":"lesion-level sensitivity for brain aneurysms on MR angiograms by 0.0698","comparator":{"against":"The same doctors reading the same MR angiograms without the software, with an expert panel's marks as the reference","before":null,"after":"Lesion-level sensitivity 0.0698 higher (95% CI 0.0358 to 0.1037)","basis":"measured","quote":"为0.0698，统计量F=9.1397,P=0.0102，95%置信区间为( 0.0358，0.1037)，病灶水平下 AI 辅助阅片与单独阅片对动脉瘤检出灵敏度差值的95%置信区间下限大于优效界值","url":"https://www.cmde.org.cn/directory/web/cmde/images/1724824253132010762.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The gain was measured in the maker's pre-market trial on stored images 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/1724824253132010762.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document and one independent news report. 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