{"id":"AIBD-1070","title":"China's CMDE finds that pathologists read cervical cytology slides faster with CCAA.91360, with accuracy no worse, in the maker's trial","summary":"In the maker's trial that China's CMDE reviewed, pathologists took a mean 64.12 seconds per cervical cytology slide with CCAA.91360, against 333.49 seconds reading digital slides alone.","date_observed":"2023-03-03","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"91360 Medical Technology (Nanjing) built CCAA.91360, software that uses a deep convolutional neural network to find and classify cells in scanned cervical cytology slides. It marks suspected abnormal cells and gives cytopathologists a diagnostic prompt. 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, with 552 subjects at two hospitals in Nanjing. Each slide was read under the microscope as the reference, and also digitally with and without the software. Mean reading time was 64.12 seconds with the software and 333.49 seconds without it. Against the microscope, sensitivity was 100% with the software and 98.79% without it. Specificity was 94.10% with the software and 93.11% without it. CMDE found that “本软件辅助数字阅片的诊断时间效率优于单独数字阅片” (software-assisted digital reading is more time-efficient than digital reading alone). On 3 March 2023, it judged that benefits outweigh risks and recommended approval. The approved use excludes cervical cancer screening, and pathologists must review the whole image.","category":"aggregate result","unexpected":false,"purpose":"91360 Medical Technology (Nanjing) built CCAA.91360 to mark suspected abnormal cells in scanned cervical cytology slides and give cytopathologists a diagnostic prompt.","system":"CCAA.91360 (宫颈细胞学数字病理图像计算机辅助分析软件)","model_version":"Release V2","developer":"91360 Medical Technology (Nanjing) Co., Ltd. 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The trial was the maker's own, and microscope reading was the reference."},"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：宫颈细胞学数字病理图像计算机辅助分析软件 (technical review report for the registration of cervical cytology digital pathology image computer-aided analysis software), acceptance no. CQZ2101339, applicant 玖壹叁陆零医学科技南京有限公司. 3 March 2023. 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：宫颈细胞学数字病理图像计算机辅助分析软件（CQZ2101339）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1710380539480034481.pdf","date":"2023-03-03","written_by":"independent","quote":"两者的均数差值为-269.37（95CI：-382.05，-156.69） ，小于方案规定的优效界值，因此认为本软件辅助数字阅片的诊断时间效率优于单独数字阅片。"},{"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：宫颈细胞学数字病理图像计算机辅助分析软件 (technical review report for the registration of cervical cytology digital pathology image computer-aided analysis software), acceptance no. CQZ2101339, applicant 玖壹叁陆零医学科技南京有限公司. 3 March 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：宫颈细胞学数字病理图像计算机辅助分析软件（CQZ2101339）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1710380539480034481.pdf","date":"2023-03-03","written_by":"independent","quote":"经综合评价，在目前认知水平上，认为该产品上市带来的受益大于风险，综合剩余风险可接受。"}],"replication":{"produced_by":["Slides prepared by the membrane-based liquid-based thin-layer method were scanned on a specified slide scanner.","The software segmented cell nuclei with a deep convolutional neural network, classified the cells and marked suspected abnormal ones for the pathologist."],"must_hold":["Pathologists review the whole digital image and not only the marked cells.","The prompts are not the sole basis for a diagnosis, and the software is not used for cervical cancer screening.","Patients who had radiotherapy or surgery removing the whole cervix are excluded."],"echoes":[]},"paired_incident":null,"headline":"*CCAA.91360* cut the time to read cervical cytology slides","metric":"a mean 64.12 seconds per cervical cytology slide with CCAA.91360, against 333.49 seconds","comparator":{"against":"Digital reading of the same slides without the software","before":"Mean diagnosis time 333.49 seconds","after":"Mean diagnosis time 64.12 seconds","basis":"measured","quote":"时间效率评价结果显示：本软件辅助数字阅片诊断时间（秒）平均值为 64.12，标准差为 27.04，中位数（Q1,Q3)为 59.00（43.50，83.00）；单独数字阅片诊断时间（秒）平均值为 333.49","url":"https://www.cmde.org.cn/directory/web/cmde/images/1710380539480034481.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The time saved was measured in the maker's pre-market trial, where microscope reading was the reference, 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/1710380539480034481.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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