{"id":"AIBD-1067","title":"China's CMDE finds that doctors scoring stroke CT scans with EASYASPECT agreed better with an expert panel in the maker's trial","summary":"In the maker's reader trial that China's CMDE reviewed, doctors' stroke CT judgments agreed with an expert panel at a kappa of 0.80 with EASYASPECT, against 0.55 without it.","date_observed":"2023-07-11","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Yukun (Beijing) Network Technology built EASYASPECT, software that uses deep learning to segment brain regions on non-contrast head CT. It judges each region for early ischemic change and computes the Alberta Stroke Program Early CT Score (ASPECTS). 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 retrospective multi-reader multi-case study of 224 cases at two hospitals in Ningbo and Nanchang. Eight doctors scored every case alone and with the software at least four weeks apart. An expert panel set the reference. Region by region, the doctors' agreement with the panel had a kappa of 0.80 with the software and 0.55 without it. For each case's total score, the intraclass correlation was 0.93 with the software and 0.75 without it. On 11 July 2023, CMDE concluded that “该产品临床使用受益大于风险” (the product's clinical benefits outweigh its risks) and recommended approval. The scans were past cases, so the scores guided no care. 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Section 三、临床评价概述 (clinical evaluation), pp. 7-8.","title":"医疗器械产品注册技术审评报告：缺血性卒中CT图像辅助评估软件（CQZ2201543）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1743664671250013909.pdf","date":"2023-07-11","written_by":"independent","quote":"医师使用AI与专家组间Kappa值（FAS和PPS：0.80）95%置信区间下限（FAS和 PPS：0.79）大于0.75，一致性较好，医师不使用AI与专家组间Kappa值（FAS和PPS：0.55）"},{"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：缺血性卒中CT图像辅助评估软件 (technical review report for the registration of ischemic stroke CT image assessment-aid software), acceptance no. CQZ2201543, applicant 语坤（北京）网络科技有限公司. 11 July 2023. Section 综合评价意见 (concluding opinion), CMDE's own judgment.","title":"医疗器械产品注册技术审评报告：缺血性卒中CT图像辅助评估软件（CQZ2201543）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1743664671250013909.pdf","date":"2023-07-11","written_by":"independent","quote":"经对申请人提交的注册申报资料进行系统评价，基于当前认知水平，认为该产品临床使用受益大于风险，注册申报资料符合现行技术审评要求，建议予以注册。"}],"replication":{"produced_by":["A deep learning algorithm segmented brain regions on non-contrast head CT, and the software judged whether each scoring region lost a point.","Eight doctors at two hospitals read every case alone and with the software in randomized order, at least four weeks apart."],"must_hold":["Patients are suspected of acute large-artery occlusion ischemic stroke within 6 hours.","Trained doctors use the score and do not base clinical decisions on it alone.","The software is not used in emergency care."],"echoes":[]},"paired_incident":null,"headline":"*EASYASPECT* brought doctors' stroke CT scores closer to experts'","metric":"a kappa of 0.80 with EASYASPECT, against 0.55 without it","comparator":{"against":"The same eight doctors scoring the same cases without the software, with an expert panel as the reference","before":"Kappa 0.55 between doctors without the software and the expert panel","after":"Kappa 0.80 between doctors with the software and the expert panel (lower 95% confidence bound 0.79)","basis":"measured","quote":"医师使用AI与专家组间Kappa值（FAS和PPS：0.80）95%置信区间下限（FAS和 PPS：0.79）大于0.75，一致性较好，医师不使用AI与专家组间Kappa值（FAS和PPS：0.55）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1743664671250013909.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The gain was measured on past scans 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/1743664671250013909.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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It judges each region for early ischemic change and computes the Alberta Stroke Program Early CT Score (ASPECTS). 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 retrospective multi-reader multi-case study of 224 cases at two hospitals in Ningbo and Nanchang. Eight doctors scored every case alone and with the software at least four weeks apart. An expert panel set the reference. Region by region, the doctors' agreement with the panel had a kappa of 0.80 with the software and 0.55 without it. For each case's total score, the intraclass correlation was 0.93 with the software and 0.75 without it. On 11 July 2023, CMDE concluded that “该产品临床使用受益大于风险” (the product's clinical benefits outweigh its risks) and recommended approval. The scans were past cases, so the scores guided no care. 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