Retrospective multicenter reader study demonstrates AI assistance improves diagnostic accuracy on CT angiography, indicating value for emergency clinical decision support workflows.
To assess the clinical impact of an artificial intelligence (AI)-based software-as-a-medical-device (SaMD) for acute aortic syndrome (AAS) detection on computed tomography angiography (CTA), and validate its effect on diagnostic accuracy in a multicenter reader study. In this retrospective study, 205 CTA scans (101 AAS-positive) were interpreted twice by nine clinicians across four specialties, without and then with AI assistance, separated by a washout interval of at least four weeks. Comparisons were made both on pooled reader-case observations and at the reader level. AI improved diagnostic accuracy (96.26% vs. 94.69%, p = 0.0058) and specificity (98.72% vs. 93.80%, p < 0.001), with a decrease in sensitivity (93.73% vs. 95.60%, p = 0.0171). At the reader level, specificity improved in all nine readers ( p = 0.004), while accuracy and sensitivity changes varied in direction. Inter-reader agreement improved from a Fleiss' kappa of 0.849–0.924. Clinicians reported greater confidence and efficiency. These findings support the integration of AI-driven clinical decision support tools into frontline diagnostic workflows for time-critical conditions such as AAS, provided that safeguards against false-negative AI output are in place.
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Huang et al. (2026) studied this question.
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