{"id":"AIBD-1091","title":"China's CMDE finds that MIAS-3000 flagged intermediate or later macular degeneration on OCT with 95.5% sensitivity in the maker's trial","summary":"In the maker's trial that China's CMDE reviewed, MIAS-3000 flagged intermediate or later age-related macular degeneration on OCT with 95.5% sensitivity and 92.1% specificity per eye.","date_observed":"2025-10-09","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Suzhou Bigvision Medical Technology built MIAS-3000, software that analyzes OCT scans of the back of the eye with a convolutional neural network. It tells eye doctors whether patients aged 50 and over have intermediate or later age-related macular degeneration with large drusen. 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 908 subjects. Doctors read the scans with the software in one group and alone in the other. The primary sensitivity per eye was 95.5% (95% CI 92.5% to 97.5%) and the specificity 92.1% (89.6% to 94.2%). Both lower bounds exceeded the target of 85%. The report does not say whether these figures describe the software or the doctors using it, and it names no reference standard. It gives a mean difference in reading time between the groups of -25.09 seconds. On 9 October 2025, 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：眼科OCT图像辅助诊断软件（CQZ2400999）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1761699620880017467.pdf","date":"2025-10-09","written_by":"independent","quote":"临床试验结果显示，主要有效性单人单眼层面 FAS 集灵敏度为 95.5%，95%CI（92.5%，97.5%）"},{"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：眼科OCT图像辅助诊断软件 (technical review report for the registration of ophthalmic OCT image diagnosis-aid software), acceptance no. CQZ2400999, applicant 苏州比格威医疗科技有限公司. 9 October 2025. Section 综合评价意见 (concluding evaluation), CMDE's own conclusion and recommendation to approve.","title":"医疗器械产品注册技术审评报告：眼科OCT图像辅助诊断软件（CQZ2400999）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1761699620880017467.pdf","date":"2025-10-09","written_by":"independent","quote":"经对申请人提交的注册申报资料进行系统评价，申报产品符合安全性、有效性的要求，符合现有认知水平，建议准予注册。"}],"replication":{"produced_by":["The algorithm analyzed each OCT slice of an eye for lesions and features of age-related macular degeneration.","The results for each eye were combined according to a Chinese clinical pathway of 2013 into a diagnostic suggestion."],"must_hold":["Patients are aged 50 or over and are suspected of or followed up for age-related macular degeneration.","Scans are taken with the BV1000 OCT device of Jiangxi Bigvision Medical Technology.","A doctor judges whether the image quality allows analysis and does not decide on the software's suggestion alone."],"echoes":[]},"paired_incident":null,"headline":"*MIAS-3000* flagged macular degeneration on OCT scans in China's review","metric":"95.5% sensitivity and 92.1% specificity per eye","comparator":{"against":"A target of 85% for the lower 95% confidence bounds of sensitivity and specificity","before":"Target of 85% for the lower confidence bounds","after":"Sensitivity 95.5%, 95%CI（92.5%，97.5%） and specificity 92.1%, 95%CI（89.6%，94.2%） per eye","basis":"measured","quote":"临床试验结果显示，主要有效性单人单眼层面 FAS 集灵敏度为 95.5%，95%CI（92.5%，97.5%）；特异度为 92.1%，95%CI（89.6%，94.2%）。PPS 集灵敏度为 95.4%，95%CI（92.5%，97.5%）；特异度为 92.3%，95%CI（89.8%，94.4%）。置信区间下限大于目标值 85%，检验假设成立。","url":"https://www.cmde.org.cn/directory/web/cmde/images/1761699620880017467.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/1761699620880017467.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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