Using a Large Language Model for Postdeployment Monitoring of FDA-Approved Artificial Intelligence: Pulmonary Embolism Detection Use Case.

Abstract

Background: Artificial intelligence (AI) is increasingly integrated into clinical workflows. The performance of AI in production can diverge from initial evaluations. Postdeployment monitoring (PDM) remains a challenging ingredient of ongoing quality assurance once AI is deployed in clinical production.

Purpose: To develop and evaluate a PDM framework that uses large language models (LLMs) for free-text classification of radiology reports, and human oversight. We demonstrate its application to monitor a commercially vended pulmonary embolism (PE) detection AI (CVPED).

Methods: We retrospectively analyzed 11,999 CT pulmonary angiography studies performed between April 30, 2023, and June 17, 2024. Ground truth was determined by combining LLM-based radiology report classification and the CVPED outputs, with human review of discrepancies. We simulated a daily monitoring framework to track discrepancies between CVPED and the LLM. Drift was defined when discrepancy rate exceeded a fixed 95% confidence interval for 7 consecutive days. The confidence interval and the optimal retrospective assessment period were determined from a stable dataset with consistent performance. We simulated drift by systematically altering CVPED or LLM sensitivity and specificity, and we modeled an approach to detect data shifts. We incorporated a human-in-the-loop selective alerting framework for continuous prospective evaluation and to investigate potential for incremental detection.

Results: Of 11,999 CT pulmonary angiography studies, 1,285 (10.7%) had PE. Overall, 373 (3.1%) had discrepant classifications between CVPED and LLM. Among 111 CVPED-positive and LLM-negative cases, 29 would have triggered an alert due to the radiologist not interacting with CVPED. Of those, 24 were CVPED false-positives, 1 was an LLM false-negative, and the framework ultimately identified 4 true-alerts for incremental PE cases. The optimal retrospective assessment period for drift detection was determined to be 2 months. A 2% to 3% decline in model specificity caused a 2- to 3-fold increase in discrepancies, and a 10% drop in sensitivity was required to produce a similar effect. For example, a 2.5% drop in LLM specificity led to a 1.7-fold increase in CVPED-negative LLM-positive discrepancies, which would have taken 22 days to detect using the proposed framework.

Conclusion: A PDM framework combining LLM-based free-text classification with a human-in-the-loop alerting system can continuously track an image-based AI's performance, alert for performance drift, and provide incremental clinical value.