{"id":"AIBD-1094","title":"China's CMDE finds that the MCS fundus software met its sensitivity and specificity targets for 11 eye diseases in the maker's trial","summary":"In the maker's trial that China's CMDE reviewed, the MCS fundus software met its targets for 11 eye diseases, with 91.18% sensitivity and 91.56% specificity for diabetic retinopathy.","date_observed":"2024-06-11","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Beijing Zhiyuan Huitu Technology built MCS, software that uses a convolutional neural network to read one color photograph of the back of an adult's eye. It flags a suspected abnormality and up to three of 11 diseases, such as diabetic retinopathy, macular hole and retinal detachment. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the company's application for Class III registration. The report says that the product is an innovative medical device. The trial was the maker's own and enrolled 2,778 fundus photographs at four institutions, with central reading as the gold standard. For every disease, the lower 95% confidence bounds of sensitivity and specificity exceeded the targets. For diabetic retinopathy, sensitivity was 91.18% (86.48% to 94.35%) against a target of 82.0%. Specificity was 91.56% (90.41% to 92.59%) against 85.0%. The lowest sensitivity was 83.77%, for dry age-related macular degeneration. On 11 June 2024, CMDE concluded that “该产品的上市为适用人群带来的受益大于风险” (putting the product on the market brings the intended population benefits that outweigh the risks). 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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：眼底病变眼底图像辅助诊断软件（CQZ2200072）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1742968101004034249.pdf","date":"2024-06-11","written_by":"independent","quote":"特异度 95%置信区间下限均高于目标值， 点估计值均高于预期值"},{"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：眼底病变眼底图像辅助诊断软件 (technical review report for the registration of fundus disease fundus image diagnosis-aid software), acceptance no. CQZ2200072, applicant 北京致远慧图科技有限公司. 11 June 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：眼底病变眼底图像辅助诊断软件（CQZ2200072）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1742968101004034249.pdf","date":"2024-06-11","written_by":"independent","quote":"认为该产品的上市为适用人群带来的受益大于风险。"}],"replication":{"produced_by":["The software first scored the quality of each photograph and analyzed only those that passed.","A single deep-learning framework estimated the probability of each disease and gave up to three prompts."],"must_hold":["Photographs are single color images of the posterior pole of an adult's eye that show the whole optic disc and macula.","Photographs come from the specified fundus camera models.","Doctors confirm or rule out disease with other examinations and do not decide on the prompts alone."],"echoes":[]},"paired_incident":null,"headline":"*MCS* flagged 11 eye diseases on fundus photos in China's review","metric":"91.18% sensitivity and 91.56% specificity for diabetic retinopathy","comparator":{"against":"Targets set for each disease from a pilot trial and the literature, with central reading as the gold standard","before":"Target of 82.0% sensitivity for diabetic retinopathy","after":"91.18% [86.48%,94.35%] sensitivity for diabetic retinopathy","basis":"measured","quote":"糖尿病视网膜病变 82.0% 91.0% 122 204 91.18% [86.48%,94.35%]","url":"https://www.cmde.org.cn/directory/web/cmde/images/1742968101004034249.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/1742968101004034249.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 flags a suspected abnormality and up to three of 11 diseases, such as diabetic retinopathy, macular hole and retinal detachment. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the company's application for Class III registration. The report says that the product is an innovative medical device. The trial was the maker's own and enrolled 2,778 fundus photographs at four institutions, with central reading as the gold standard. For every disease, the lower 95% confidence bounds of sensitivity and specificity exceeded the targets. For diabetic retinopathy, sensitivity was 91.18% (86.48% to 94.35%) against a target of 82.0%. Specificity was 91.56% (90.41% to 92.59%) against 85.0%. The lowest sensitivity was 83.77%, for dry age-related macular degeneration. On 11 June 2024, CMDE concluded that “该产品的上市为适用人群带来的受益大于风险” (putting the product on the market brings the intended population benefits that outweigh the risks). 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