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At lesion level, the polyp miss rate was 12.41% with the software and 50.80% without, a difference of -38.39% (95% CI -42.87% to -33.58%). The adenoma miss rate was 17.95% against 28.93%. The adenoma detection rate at the first examination showed no statistically significant difference between the groups. On 16 December 2024, 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 define a missed polyp or say whether the software changed any patient's treatment.","category":"aggregate result","unexpected":false,"purpose":"Changsha Huiwei Intelligent Medical Technology built HW-ES to show licensed endoscopists the areas of suspected polyps in real time during adult colonoscopy.","system":"HW-ES (肠息肉电子下消化道内窥镜图像辅助检测软件)","model_version":"Release V1","developer":"Changsha Huiwei Intelligent 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内窥镜图像辅助检测软件（CQZ2302046）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1742969333809034777.pdf","date":"2024-12-16","written_by":"independent","quote":"主要评价指标：息肉漏诊率，FAS 集病灶水平，试验组为 12.41%，对照组为 50.80%，组间差值为-38.39%"},{"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 colon polyp detection-aid software for electronic lower gastrointestinal endoscope images), acceptance no. CQZ2302046, applicant 长沙慧维智能医疗科技有限公司. 16 December 2024. 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内窥镜图像辅助检测软件（CQZ2302046）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1742969333809034777.pdf","date":"2024-12-16","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":["A dual-stream deep convolutional neural network checked each video frame, and a sliding-window algorithm removed likely false alarms.","The software showed suspected polyp areas in real time on a separate video output from the endoscope's image processor."],"must_hold":["Patients are adults aged 18 to 85 with adequate bowel preparation.","The specified endoscope models 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":"*HW-ES* helped endoscopists miss fewer colon polyps in a trial","metric":"missed 12.41% of polyps, against 50.80% without it","comparator":{"against":"Endoscopists examining without the software in the same randomized trial","before":"50.80% lesion-level polyp miss rate","after":"12.41% lesion-level polyp miss rate","basis":"measured","quote":"主要评价指标：息肉漏诊率，FAS 集病灶水平，试验组为12.41%，对照组为50.80%，组间差值为-38.39%，95%置信区间为[-42.87%，-33.58%]，上限低于目标值0","url":"https://www.cmde.org.cn/directory/web/cmde/images/1742969333809034777.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/1742969333809034777.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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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内窥镜图像辅助检测软件（CQZ2302046）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1742969333809034777.pdf","date":"2024-12-16","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。"}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sources[].id":{"state":"value_present","value":{"kind":"identifiers","identifiers":["AIBD-1060-source-0001","AIBD-1060-source-0002"],"role":"Existing evidence items, in their original order"},"provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"review_state":"record_mapped","coverage":"complete"},"sources[].language":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"sources[].relationship":{"state":"value_present","value":{"kind":"record_fields","fields":{"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 colon polyp detection-aid software for electronic lower gastrointestinal endoscope images), acceptance no. CQZ2302046, applicant 长沙慧维智能医疗科技有限公司. 16 December 2024. 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（CQZ2302046）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1742969333809034777.pdf","date":"2024-12-16","written_by":"independent","quote":"主要评价指标：息肉漏诊率，FAS 集病灶水平，试验组为 12.41%，对照组为 50.80%，组间差值为-38.39%"},{"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 colon polyp detection-aid software for electronic lower gastrointestinal endoscope images), acceptance no. CQZ2302046, applicant 长沙慧维智能医疗科技有限公司. 16 December 2024. 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内窥镜图像辅助检测软件（CQZ2302046）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1742969333809034777.pdf","date":"2024-12-16","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。"}]}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["evidence"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"},"sources[].upstream_sources":{"state":"unresolved","provenance":{"kind":"curatorial","basis":"Editorial assignment.","record_fields":[],"source_refs":[]},"reason":"This is an explicit unresolved assignment: the sources on record do not settle this question.","review_state":"not_assessed","coverage":"partial"},"strategic_assessments[]":{"state":"unresolved","review_state":"not_assessed","coverage":"partial","family":"strategic assessments"},"summary":{"state":"value_present","value":{"kind":"record_fields","fields":{"summary":"In the maker's randomized trial that China's CMDE reviewed, endoscopists using HW-ES missed 12.41% of polyps, against 50.80% without it.","account":"Changsha Huiwei Intelligent Medical Technology built HW-ES, deep learning software that shows suspected polyps in real time on a separate video screen during adult colonoscopy. 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