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The trial was the maker's own, a paired multi-reader multi-case study of 400 subjects at three sites, half of them positive. Imaging, thoracic surgery and pathology experts set the reference. Doctors' subject-level area under the ROC curve was 0.8397 with the software and 0.7325 without. Nodule-level sensitivity rose by 7.64% (95% CI 6.13% to 9.15%) and specificity by 12.58%. On 29 September 2024, CMDE concluded that “该产品上市带来的受益大于风险” (putting the product on the market brings benefits that outweigh the risks). It recommended approval. The product is not for lung cancer screening. 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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：肺结节CT图像辅助诊断软件（CQZ2302309）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1729664104391037246.pdf","date":"2024-09-29","written_by":"independent","quote":"经综合评价，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":["A doctor selected each nodule on the CT image.","The software combined morphological features with deep learning to flag a suspected malignancy risk for the selected nodule."],"must_hold":["Nodules are 4 mm or larger on adult chest CT and are not pure ground-glass nodules.","The software is not used for lung cancer screening.","Trained doctors make the final judgment and do not base a clinical decision on the software alone."],"echoes":[]},"paired_incident":null,"headline":"*Dr.Wise AI Lung Cancer* helped doctors rate lung nodule risk on CT","metric":"area under the ROC curve for suspected malignant lung nodules rose from 0.7325 to 0.8397","comparator":{"against":"The same doctors reading the same CT cases without the software, with imaging, thoracic surgery and pathology experts as the reference","before":"Subject-level area under the ROC curve 0.7325±0.0234","after":"Subject-level area under the ROC curve 0.8397±0.0165","basis":"measured","quote":"AI+医生联合阅片和医生单独阅片的受试者水平ROC曲线下面积分别为0.8397±0.0165 和0.7325±0.0234，组间差值为0.1072±0.0130，95%CI 为（0.0797,0.1346），其下限大于0","url":"https://www.cmde.org.cn/directory/web/cmde/images/1729664104391037246.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The gain was measured in the maker's pre-market reader 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/1729664104391037246.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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