{"id":"AIBD-1066","title":"China's CMDE finds that endoscopists using EC01-01 detected more colon polyps in the maker's trial","summary":"In the maker's trial that China's CMDE reviewed, endoscopists using EC01-01 detected 94.7% of polyps, against 84.5% without it.","date_observed":"2023-11-02","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Xiamen Yingnuo Medical Technology built EC01-01, deep learning software that boxes suspected polyps in images from adult colorectal endoscopy. 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, parallel-controlled study of 1,020 subjects at four sites in China. Endoscopists in one group worked with the software and in the other performed conventional colonoscopy. Two gastroenterology experts set the reference from the recorded videos. A third expert settled disagreements. Polyp-level sensitivity was 94.7% with the software and 84.5% without. The report gives the difference as 10.5% (95% CI 7.7% to 13.3%). Patient-level specificity was 100% against 99.5%. No device-related adverse event occurred. On 2 November 2023, 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. The report does not say whether patients were randomized or whether the detections changed any patient's treatment.","category":"aggregate result","unexpected":false,"purpose":"Xiamen Yingnuo Medical Technology built EC01-01 to identify and show the areas of suspected polyps in images from adult colorectal endoscopy.","system":"EC01-01 (肠息肉电子下消化道图像辅助检测软件)","model_version":"Release V1","developer":"Xiamen Yingnuo Medical Technology Co., Ltd. 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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：肠息肉电子下消化道图像辅助检测软件（CQZ2200605）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1700788508279067087.pdf","date":"2023-11-02","written_by":"independent","quote":"医生在 AI 辅助下息肉检出敏感性（以息肉为单位）为 94.7%，医生独立检出敏感性 84.5%，两组率差为 10.5%（95CI：7.7%，13.3%） ，P<0.001，试验组优于对照组成立"},{"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：肠息肉电子下消化道图像辅助检测软件 (technical review report for the registration of colon polyp detection-aid software for electronic lower gastrointestinal images), acceptance no. CQZ2200605, applicant 厦门影诺医疗科技有限公司. 2 November 2023. 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：肠息肉电子下消化道图像辅助检测软件（CQZ2200605）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1700788508279067087.pdf","date":"2023-11-02","written_by":"independent","quote":"根据申请人提供的申报资料，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 cropped the endoscope's field of view, ran a deep learning detector and drew a box around each suspected polyp.","Endoscopists performed colonoscopy with the software's boxes as an aid."],"must_hold":["Patients are adults having colorectal endoscopy.","The specified endoscope models and image processors are used in white-light mode.","Endoscopists judge each mark and do not base a clinical decision on the software alone."],"echoes":[]},"paired_incident":null,"headline":"*EC01-01* helped endoscopists find more colon polyps in a trial","metric":"detected 94.7% of polyps, against 84.5% without it","comparator":{"against":"Endoscopists performing conventional colonoscopy in the parallel control group, with two experts' video review as the reference","before":"84.5% polyp-level sensitivity","after":"94.7% polyp-level sensitivity","basis":"measured","quote":"医生在 AI 辅助下息肉检出敏感性（以息肉为单位）为 94.7%，医生独立检出敏感性 84.5%，两组率差为 10.5%（95CI：7.7%，13.3%） ，P<0.001，试验组优于对照组成立","url":"https://www.cmde.org.cn/directory/web/cmde/images/1700788508279067087.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 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/1700788508279067087.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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