{"id":"AIBD-1069","title":"China's CMDE finds that endoscopists using EndoAngel's EA PC-LGI detected more polyps in the maker's colonoscopy trial","summary":"In EndoAngel's colonoscopy trial that China's CMDE reviewed, endoscopists using EA PC-LGI detected 84.97% of polyps, against 72.07% in colonoscopies without it.","date_observed":"2023-04-20","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Wuhan EndoAngel Medical Technology built EA PC-LGI, software that uses deep learning to mark suspected polyps on a separate monitor during colonoscopy. It also recognizes the cecum and times the withdrawal of the scope. 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 trial at three institutions in China. Patients had colonoscopy with or without the software, and experts reviewed the recorded videos to set the reference. Polyp-level sensitivity was 84.97% with the software and 72.07% without it, and specificity was non-inferior. CMDE wrote that “医生在本产品辅助下能够一定程度上提高息肉检出率” (with the product's help, doctors can raise the polyp detection rate to a certain extent). On 20 April 2023, it judged that benefits outweigh risks and recommended approval. NMPA announced the approval on 12 May 2023 and wrote that the product helps by “reducing missed detections”. A paper on the trial, which EndoAngel funded, reports that 1,293 patients took part at centers in Shanghai, Beijing and Wuhan in 2021.","category":"aggregate result","unexpected":false,"purpose":"Wuhan EndoAngel Medical Technology built EA PC-LGI to mark suspected polyps in real time during adult colonoscopy and to monitor the cecum, withdrawal time and withdrawal speed.","system":"EA PC-LGI (肠息肉电子下消化道内窥镜图像辅助检测软件)","model_version":"Release V1.0","developer":"Wuhan EndoAngel Medical Technology Co., Ltd. (武汉楚精灵医疗科技有限公司)","deployer":"Wuhan EndoAngel Medical Technology (prospective trial at Ruijin Hospital, Beijing Cancer Hospital and the Central Hospital of Wuhan)","location":"Shanghai, Beijing and Wuhan, China","domain":"Healthcare","segment":null,"benefit_type":"Improved Task Accuracy","work_activities":["4.A.1.b.1","4.A.1.a.2"],"taxonomy_note":null,"registry_ids":{"chictr":"ChiCTR2100041988"},"ratings":[{"group":"organizational","depth":null,"reason":"Endoscopists found more polyps with the software in the maker's pre-market trial, and the report gives no outcome of care."},{"group":"personal","depth":null,"reason":"Patients in the software group had more of their polyps detected, but the report gives no outcome for their health."}],"ai_role":{"status":"assessed","statement":"Patients had colonoscopy with or without the software in parallel groups, so the gain in sensitivity is attributed to the software. The trial was the maker's own, and EndoAngel funded the published paper on it."},"evidence":[{"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内窥镜图像辅助检测软件 (technical review report for the registration of intestinal polyp lower gastrointestinal endoscope image detection-aid software), acceptance no. CQZ2200536, applicant 武汉楚精灵医疗科技有限公司. 20 April 2023. 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内窥镜图像辅助检测软件（CQZ2200536）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1742968427970072912.pdf","date":"2023-04-20","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 84.97%（95CI：82.76%，87.17%） ，优于医生独立检出敏感性 72.07%（95CI：69.43%，74.71%）"},{"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内窥镜图像辅助检测软件 (technical review report for the registration of intestinal polyp lower gastrointestinal endoscope image detection-aid software), acceptance no. CQZ2200536, applicant 武汉楚精灵医疗科技有限公司. 20 April 2023. Section 四、产品受益风险判定 (benefit-risk determination), CMDE's own judgment.","title":"医疗器械产品注册技术审评报告：肠息肉电子下消化道内窥镜图像辅助检测软件（CQZ2200536）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1742968427970072912.pdf","date":"2023-04-20","written_by":"independent","quote":"临床试验结果显示，医生在本产品辅助下能够一定程度上提高息肉检出率。"},{"kind":"regulatory document","citation":"National Medical Products Administration (NMPA), China. Computer Aided Detection Software for Intestinal Polyps in Lower Gastrointestinal Endoscopy Approved for Marketing. NMPA English website, 12 May 2023.","title":"Computer Aided Detection Software for Intestinal Polyps in Lower Gastrointestinal Endoscopy Approved for Marketing","url":"https://english.nmpa.gov.cn/2023-05/12/c_923528.htm","date":"2023-05-12","written_by":"independent","quote":"Compared with similar products already marketed at home and abroad, this product uses deep learning technology, perceptual hash algorithm, and other technologies to assist doctors in operation control while identifying polyps, further ensuring the quality of proctoscopy, reducing missed detections, and improving the standardization of examination operations."},{"kind":"peer-reviewed study","citation":"Zhang H, Wu Q, Sun J, Wang J, Zhou L, Cai W, Zou D. A computer-aided system improves the performance of endoscopists in detecting colorectal polyps: a multi-center, randomized controlled trial. Frontiers in Medicine 10:1341259, 24 January 2024. doi:10.3389/fmed.2023.1341259. A sponsor-initiated study funded by Wuhan ENDOANGEL Medical Technology.","title":"A computer-aided system improves the performance of endoscopists in detecting colorectal polyps: a multi-center, randomized controlled trial","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC10847558/","date":"2024-01-24","written_by":"evaluator","quote":"The sensitivity of the endoscopists in the two groups was 84.97% (95% Confidence Interval [CI], 82.76-87.17%) and 72.07% (95% CI, 69.43-74.71%), the difference in sensitivity between the two groups was 12.89% (95% CI, 9.46-16.33%)"}],"replication":{"produced_by":["The software took video from the endoscope's image processor and marked suspected polyps with boxes on a separate monitor.","Endoscopists at three centers performed colonoscopy with or without the software, and experts reviewed the recorded videos as the reference."],"must_hold":["Patients are adults having colonoscopy in a medical institution.","The endoscope and image processor are specified models used in white light mode.","Endoscopists judge polyps from the images and the patient's condition and do not decide on the marks alone."],"echoes":[]},"paired_incident":null,"headline":"*EA PC-LGI* helped endoscopists find more polyps in a Chinese trial","metric":"detected 84.97% of polyps, against 72.07% in colonoscopies without it","comparator":{"against":"Colonoscopy without the software in the same trial, with experts' review of the recorded videos as the reference","before":"72.07% polyp-level sensitivity","after":"84.97% 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 84.97%（95CI：82.76%，87.17%） ，优于医生独立检出敏感性 72.07%（95CI：69.43%，74.71%）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1742968427970072912.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The gain in detection was measured in the maker's pre-market trial, and the report gives no outcome for the patients' health.","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/1742968427970072912.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: two independent regulatory documents and the evaluators' peer-reviewed study. 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