{"id":"AIBD-1083","title":"China's CMDE finds that the JF CXR-1 tuberculosis software agreed with a central reading panel on 92.70% of cases in the maker's trial","summary":"In the maker's six-center trial that China's CMDE reviewed, JF CXR-1 agreed with a central reading panel on 94.19% of positive and 91.17% of negative chest X-rays.","date_observed":"2022-10-18","date_basis":"source publication","date_precision":"day","benefit_status":"intended","source_collection":null,"source_entry":null,"account":"Jiangxi Zhongke Jiufeng Smart Medical Technology built JF CXR-1, software that uses deep learning to flag possible active tuberculosis on frontal chest DR images. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the company's application for Class III registration with priority. The trial was the maker's own, a prospective study of 1,165 cases at six centers, with an independent central reading panel as the reference. In the full analysis set of 1,161 cases, positive agreement was 94.19% and negative agreement 91.17%, above targets of 85% and 70%. The report says that “Kappa 值为 0.854，表明试验产品结果与中心阅片结果一致” (the kappa value was 0.854, showing agreement with the central reading). Against the clinical diagnosis of 1,121 patients, sensitivity was 79.30% and specificity 90.45%. On 133 cases that the panel disputed, the software agreed with the arbitrating physician in 74.44%. On 18 October 2022, CMDE concluded that “该产品上市带来的受益大于风险” (the benefits of putting the product on the market outweigh the risks) and recommended approval. It asked the company to study how well the algorithm generalizes and to review its use yearly.","category":"aggregate result","unexpected":false,"purpose":"Jiangxi Zhongke Jiufeng Smart Medical Technology built JF CXR-1 to prompt trained physicians when frontal chest DR images suggest active tuberculosis in patients without immune deficiency.","system":"JF CXR-1 (肺结核X射线图像辅助评估软件)","model_version":"Release 2 (full version 2.0.0)","developer":"Jiangxi Zhongke Jiufeng Smart Medical Technology Co., Ltd. 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CQZ2100859, applicant 江西中科九峰智慧医疗科技有限公司. 18 October 2022. Section 四、产品受益风险判定 (benefit-risk determination), CMDE's own judgment of benefit and risk.","title":"医疗器械产品注册技术审评报告：肺结核X射线图像辅助评估软件（CQZ2100859）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1666746162220026616.pdf","date":"2022-10-18","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":["The software read frontal chest DR images with a deep learning tuberculosis module on a server.","An independent central reading panel served as the reference, and an arbitrating physician re-read 133 disputed cases."],"must_hold":["The product does not apply to healed (old) pulmonary tuberculosis or to patients with immune deficiencies such as neutrophil disorders.","Trained physicians use the prompt and do not base a diagnosis or treatment decision on it alone."],"echoes":[]},"paired_incident":null,"headline":"*JF CXR-1* agreed with expert readers on TB chest X-rays in a trial","metric":"94.19% of positive and 91.17% of negative chest X-rays","comparator":{"against":"Preset targets for agreement with an independent central reading panel","before":"Targets of 85% positive agreement and 70% negative agreement","after":"94.19% positive agreement and 91.17% negative agreement","basis":"measured","quote":"在 FAS 集中，阳性符合率为 94.19% (95%CI:91.99%-95.81%)，阴性符合率为 91.17% (95%CI:88.54%-93.24%)，总体符合率为 92.70% (95%CI:91.05%-94.07%)。将统计结果与预设目标值进行比较，阳性符合率 95%CI 下限为 91.99%，大于阳性符合率的目标值 85%；阴性符合率 95%CI 下限为 88.54%，大于阴性符合率的目标值 70%，满足临床方案要求。","url":"https://www.cmde.org.cn/directory/web/cmde/images/1666746162220026616.pdf"},"later":null,"value":null,"developer_country":"China","deployer_country":"China","unrated_because":"The agreement 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/1666746162220026616.pdf","editor":"AIBD"}],"confidence":"found","shade":"high","claim_status":"Found by a regulator","claim_basis":"Sources: one independent regulatory document. 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Section 四、产品受益风险判定 (benefit-risk determination), CMDE's own judgment of benefit and risk.","title":"医疗器械产品注册技术审评报告：肺结核X射线图像辅助评估软件（CQZ2100859）","url":"https://www.cmde.org.cn/directory/web/cmde/images/1666746162220026616.pdf","date":"2022-10-18","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。"}]}},"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-1083-source-0001","AIBD-1083-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：肺结核X射线图像辅助评估软件 (technical review report for the registration of pulmonary tuberculosis X-ray image assessment-aid software), acceptance no. 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The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the company's application for Class III registration with priority. The trial was the maker's own, a prospective study of 1,165 cases at six centers, with an independent central reading panel as the reference. In the full analysis set of 1,161 cases, positive agreement was 94.19% and negative agreement 91.17%, above targets of 85% and 70%. The report says that “Kappa 值为 0.854，表明试验产品结果与中心阅片结果一致” (the kappa value was 0.854, showing agreement with the central reading). Against the clinical diagnosis of 1,121 patients, sensitivity was 79.30% and specificity 90.45%. On 133 cases that the panel disputed, the software agreed with the arbitrating physician in 74.44%. On 18 October 2022, CMDE concluded that “该产品上市带来的受益大于风险” (the benefits of putting the product on the market outweigh the risks) and recommended approval. 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The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the company's application for Class III registration with priority. The trial was the maker's own, a prospective study of 1,165 cases at six centers, with an independent central reading panel as the reference. In the full analysis set of 1,161 cases, positive agreement was 94.19% and negative agreement 91.17%, above targets of 85% and 70%. The report says that “Kappa 值为 0.854，表明试验产品结果与中心阅片结果一致” (the kappa value was 0.854, showing agreement with the central reading). Against the clinical diagnosis of 1,121 patients, sensitivity was 79.30% and specificity 90.45%. On 133 cases that the panel disputed, the software agreed with the arbitrating physician in 74.44%. On 18 October 2022, CMDE concluded that “该产品上市带来的受益大于风险” (the benefits of putting the product on the market outweigh the risks) and recommended approval. It asked the company to study how well the algorithm generalizes and to review its use yearly.","replication":{"produced_by":["The software read frontal chest DR images with a deep learning tuberculosis module on a server.","An independent central reading panel served as the reference, and an arbitrating physician re-read 133 disputed cases."],"must_hold":["The product does not apply to healed (old) pulmonary tuberculosis or to patients with immune deficiencies such as neutrophil disorders.","Trained physicians use the prompt and do not base a diagnosis or treatment decision on it alone."],"echoes":[]}}},"provenance":{"kind":"legacy_record","basis":"Editorial assignment.","record_fields":["account","replication"],"source_refs":[]},"review_state":"record_mapped","coverage":"partial"}},"summary":{"total":91,"addressed":91,"known":28,"reviewed":2,"reviewed_complete":2,"reviewed_partial":0,"record_mapped":26,"review_not_assessed":63,"not_assessed":0,"complete":false,"by_state":{"value_present":28,"not_reported":0,"unresolved":63,"not_assessed":0,"not_applicable":0,"withheld":0,"source_unavailable":0}}},"presentation_version":"6a41bd51ecd07593d88c1416428bc36490bc243cfac1943278538cdeca6381d7"}