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The trial was the maker's own, with 494 cases at Peking Union Medical College Hospital, the Second Xiangya Hospital and Dongyang People's Hospital. Investigators read each smear alone and with the software, and an expert panel set the reference. Accuracy was higher with the software in all nine categories, for example 70.22% against 39.10% for abnormal white cells. In leukemia and suspected leukemia cases, total agreement was 86.44% with the software and 81.17% without it. On 2 November 2022, CMDE found that the product “可提高检验人员识别各类白细胞的准确性” (can improve laboratory staff's accuracy in identifying the various types of white blood cells). It judged that benefits outweigh risks and recommended approval. 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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：外周血细胞图像白细胞辅助识别软件（CQZ2100110）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1710380134133032056.pdf","date":"2022-11-02","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":["Blood smear images were taken with a specified microscope and camera, and trained staff accepted their quality.","The software segmented and classified white blood cells with deep learning, and investigators read the smears with its results."],"must_hold":["Patients have abnormal white cell results on a routine blood count that call for a smear recheck.","Trained laboratory staff use the results, which are not the sole basis for testing or clinical decisions."],"echoes":[]},"paired_incident":null,"headline":"*CellaScope* helped lab staff identify white blood cells on smears","metric":"70.22% of abnormal white blood cells on smears with CellaScope, against 39.10% alone","comparator":{"against":"The same investigators reading the same smears alone, with an expert panel's reading as the reference","before":"39.10% of abnormal white blood cells identified correctly","after":"70.22% of abnormal white blood cells identified correctly","basis":"measured","quote":"经统计分析软件辅助研究者判读结果优效于研究者独立判读结果。","url":"https://www.cmde.org.cn/directory/web/cmde/images/1710380134133032056.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/1710380134133032056.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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