What happened
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.
Sources
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Regulatory document, by authors with no tie to the system.
Kappa 值为 0.854,表明试验产品结果与中心阅片结果一致
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。
Details
AI system
- Reported configuration
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Release 2 (full version 2.0.0)
- Workflow
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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.
Follow-up
- Conditions for replication
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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.
Entry details
- Sector
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Healthcare.
- Purpose
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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.
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model, provider, role, configuration, inputs and outputs, autonomy, human oversight, AI contribution, beneficiaries, reach, distribution and access, duration, every measurement question, every money question, ownership and control, dependencies, cross-border connections, geopolitical implications, replication attempts, availability, institutional decision, grounds, action and result, success criterion, every evidence question, observed or intended, alternative assessments, related entries, other identifiers, category mappings.
Cite this record
Peter H. Vartanian. (2026). JF CXR-1 agreed with expert readers on TB chest X-rays in a trial (AIBD-1083). Artificial Intelligence Benefits Database, edition of 1 November 2026. https://petervartanian.xyz/aibd/records/AIBD-1083.html (archived at https://doi.org/10.7910/DVN/AADSII, version 7.0)