Silent Drift and Site-level Variance in Clinical AI: Real-world performance and subgroup analysis for post-market monitoring of an FDA-cleared artificial intelligence (AI) triage tool for high-risk use case of pulmonary embolism

Background. FDA-cleared artificial intelligence (AI) triage tool for pulmonary embolism (PE) detection has been widely used; however, its performance has not been analyzed for subgroups, clinical sites, and temporal stability. Methods. This retrospective, six-site health system study evaluated the Aidoc BriefCase PE triage model (K190072) across 14,736 CT pulmonary angiography (CTPA) examinations between July 2023 and March 2026. Reference-standard PE characteristic labels were extracted from radiology reports using a zero-shot LLM pipeline validated against a radiologist-annotated 600 reports

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