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A prospective multicenter single-arm trial used senior doctors' readings as the gold standard. CMDE's report says that the trial's conclusion was “诊断准确度指标达到预期目标” (the measures of diagnostic accuracy reached the preset targets). A retrospective trial also met its primary endpoints. The report gives no figures. Time per diagnosis and daily diagnoses per doctor were secondary endpoints, with no results reported. On 31 July 2020, CMDE recommended approval. 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Section 三、临床评价摘要 (clinical evaluation summary).","title":"医疗器械产品注册技术审评报告：糖尿病视网膜病变眼底图像辅助诊断软件（CQZ1900668）","url":"https://www.cmde.org.cn/directory/web/cmde/images/zMfE8rKhytPN+MSksqGx5NHbtdfNvMxuKjW+tXvtsI7bz+o6hDUVoxOTAwNjY4o6lzLnBkZg==.pdf","date":"2020-07-31","written_by":"independent","quote":"该产品对需要获得糖尿病视网膜病变诊断的人员是否可见 II 期或 II 期以上的糖尿病视网膜病变进行辅助诊断的诊断准确度指标达到预期目标"}],"replication":{"produced_by":["The software analyzed color fundus photos of both eyes with a convolutional neural network on a cloud server.","Trained licensed doctors checked image quality before analysis.","Senior doctors' readings served as the gold standard."],"must_hold":["Patients are adults with diabetes.","Photos come from the specified fundus camera models, and trained doctors approve their quality.","Licensed doctors make the diagnosis and do not decide on the software's result alone."],"echoes":[]},"paired_incident":null,"headline":"*AIDRscreening* met its retinopathy accuracy targets in China's review","metric":null,"comparator":{"against":"Senior doctors' readings as the gold standard, with preset accuracy targets","before":"Preset targets (values not given)","after":"Diagnostic accuracy reached the targets (no figures given)","basis":"measured","quote":"该产品对需要获得糖尿病视网膜病变诊断的人员是否可见 II 期或 II 期以上的糖尿病视网膜病变进行辅助诊断的诊断准确度指标达到预期目标","url":"https://www.cmde.org.cn/directory/web/cmde/images/zMfE8rKhytPN+MSksqGx5NHbtdfNvMxuKjW+tXvtsI7bz+o6hDUVoxOTAwNjY4o6lzLnBkZg==.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The report gives no figures from the maker's pre-market trials and 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/zMfE8rKhytPN+MSksqGx5NHbtdfNvMxuKjW+tXvtsI7bz+o6hDUVoxOTAwNjY4o6lzLnBkZg==.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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