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The trial was the maker's own, a retrospective, fully crossed multi-reader multi-case study at four sites in China. Its sample size was 340 cases, with pathology as the reference. Readers with the software reached a lesion-level sensitivity of 85.80%, against 79.94% alone, a difference of 5.86% (95% CI 1.72% to 9.99%). Case-level specificity was 80.87% against 78.31%, which met the non-inferiority margin. The AFROC-AUC was 0.865 against 0.831. On 27 January 2026, 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). It 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：胃部病变电子内窥镜图像辅助分诊软件（CQZ2400681）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1773816067239059668.pdf","date":"2026-01-27","written_by":"independent","quote":"试验组（阅片者在软件辅助下阅片）识别病变的病灶水平的灵敏度及其 95%CI 为 85.80%（82.45%，89.15%）"},{"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：胃部病变电子内窥镜图像辅助分诊软件 (technical review report for the registration of gastric lesion electronic endoscopy image triage-aid software), acceptance no. CQZ2400681, applicant 武汉楚精灵医疗科技有限公司. 27 January 2026. 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：胃部病变电子内窥镜图像辅助分诊软件（CQZ2400681）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1773816067239059668.pdf","date":"2026-01-27","written_by":"independent","quote":"经综合评价，在目前认知水平上，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 ran only on frozen images that it recognized as taken inside the digestive tract in a magnifying electronic chromoendoscopy mode.","It gave a triage prompt on whether the image showed features of high-grade intraepithelial neoplasia or worse."],"must_hold":["A doctor has judged that a focal gastric lesion needs magnified electronic chromoendoscopy.","Images come from the specified endoscopes and image processors.","Trained doctors make the diagnosis and do not base a decision on the prompt alone."],"echoes":[]},"paired_incident":null,"headline":"*EA PC-UGI* helped readers spot more stomach lesions in a trial","metric":"a lesion-level sensitivity of 85.80% for gastric lesions, against 79.94% alone","comparator":{"against":"The same readers reading the same images without the software, with pathology as the reference","before":"79.94%（75.70%，84.18%） lesion-level sensitivity","after":"85.80%（82.45%，89.15%） lesion-level sensitivity","basis":"measured","quote":"试验组（阅片者在软件辅助下阅片）识别病变的病灶水平的灵敏度及其 95%CI 为 85.80%（82.45%，89.15%），优于对照组（阅片者单独阅片）识别病变的灵敏度 79.94%（75.70%，84.18%），两组差值为 5.86%（1.72%，9.99%），优效性假设成立","url":"https://www.cmde.org.cn/directory/web/cmde/images/1773816067239059668.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The gain was measured in the maker's pre-market trial 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/1773816067239059668.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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