uAI-AorticDissection flagged aortic dissections in China's review

What happened

Shanghai United Imaging Intelligence built uAI-AorticDissection, software that uses deep learning on aortic CT angiography of adults to flag suspected acute aortic dissection for triage. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the company's application for Class III registration. The trial was the maker's own, a retrospective, multicenter, single-arm study of 380 subjects at three institutions. An expert panel's reading served as the reference. The trial excluded patients with aortic ulcer, intramural hematoma, aneurysm, rupture or earlier aortic surgery or endovascular treatment. Case-level sensitivity was 99.46% (95% CI 96.99% to 99.90%) and specificity 98.45% (95% CI 95.55% to 99.47%). Both lower bounds exceeded the protocol's targets, which the report does not state. The software took 33.27 seconds per case on average, and no device defect occurred. On 4 November 2024, 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. The trial used stored images, so the prompts guided no care. It did not compare doctors' reading with and without the software.