cs.CVSep 29, 2026

Multi-Site Real-World Performance of Commercial AI for Pulmonary and Incidental Pulmonary Embolism Detection

Authors: Aawez Mansuri, Mohammadreza Chavoshi, Theodorus Dapamede, Wasif Bala, Beatrice Brown-Mulry, Rohan Isaac, Bardia Khosravi, Hanzhou Li, +8 more

Organizations: Department of Radiology and Imaging Sciences, Emory University School of Medicine, Atlanta, GA, USA · Department of Radiology and Biomedical Imaging, Yale University New Haven, CT, USA · Department of Biomedical Informatics, Emory University, Atlanta, GA, USA

Abstract

Pulmonary embolism (PE) is a leading cause of cardiovascular mortality, yet the real-world performance of FDA-cleared AI detection models remains incompletely characterized. We retrospectively evaluated two FDA-cleared AI algorithms from a single commercial platform (Aidoc Medical BriefCase), one for PE triage on dedicated CT pulmonary angiography (CTPA; n = 30,678) and one for incidental PE (iPE) detection on routine contrast-enhanced CTs (n = 37,191), across a 17-facility academic health system. Reference-standard labels were extracted from radiology reports using a validated LLM pipeline (97% accuracy, kappa = 0.94). The PE model achieved 86.8% sensitivity and 99.1% specificity, with sensitivity declining from 99.3% for saddle emboli to 72.9% for subsegmental PE, and from 89.7% for acute to 65.3% for non-acute PE. The iPE model achieved 73.5% sensitivity and 99.8% specificity. Both models demonstrated lower sensitivity than FDA-clearance benchmarks while exceeding cleared specificity, with diminishing performance for peripheral and non-acute emboli mirroring known human reader limitations and underscoring the need for standardized post-market surveillance of AI-enabled medical devices.

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