What happened
Yukun (Beijing) Network Technology built LiverMRDoc, software that uses deep learning to outline liver segments on MRI and detect suspected focal lesions of 5 mm or more. It lists the cases with lesions so that doctors can triage them. China's Center for Medical Device Evaluation (CMDE) reviewed the company's application for Class III registration. The trial was the maker's. It used stored images of 490 cases at Beijing Friendship Hospital and Ningbo Hwa Mei Hospital, with an expert panel's results as the reference. Lesion-level sensitivity was 94.83% and case-level specificity was 91.60%, with the lower bounds of their 95% confidence intervals above targets of 88.4% and 81%. Judgments took a median of 7.47 minutes with the software and 9.45 minutes for the expert panel, a statistically significant difference. On 22 November 2023, CMDE judged 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 registration. The time comparison is with the panel that set the reference standard, so it does not isolate the software. CMDE notes that false negatives could delay treatment.
Sources
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Regulatory document, by authors with no tie to the system.
试验组与专家组判定时间,FAS分析集,软件判定时间中位数 7.47min,专家组判定时间中位数 9.45min,软件判定时间小于专家组判定时间,P<0.0001,两组差值有统计学意义
Details
AI system
- Reported configuration
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Release 2.0 (full version 2.0.1.001)
- Workflow
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The software extracted liver segments from MR images with deep learning and detected suspected focal lesions in them. It listed the cases with suspected lesions, and doctors could add, delete or edit lesions before a text report was made. An expert panel's results served as the reference standard.
Follow-up
- Conditions for replication
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Patients are adults, and the lesions are 5 mm or larger. Trained doctors use the results as a reference and do not base a clinical decision on the software alone.
Entry details
- Sector
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Healthcare.
- Purpose
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Yukun (Beijing) Network Technology built LiverMRDoc to help trained doctors triage suspected focal liver lesions of 5 mm or more in adults on MRI.
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Cite this record
Peter H. Vartanian. (2026). LiverMRDoc reached liver MRI judgments faster in China's review (AIBD-1075). Artificial Intelligence Benefits Database, edition of 1 November 2026. https://petervartanian.xyz/aibd/records/AIBD-1075.html (archived at https://doi.org/10.7910/DVN/AADSII, version 7.0)