EPIQ Series Diagnostic Ultrasound Systems; Affiniti Series Diagnostic Ultrasound Systems

This document describes Philips Ultrasound's integration of Segmental Wall Motion v2 and AI-based Auto EF with contrast software into its EPIQ and Affiniti Series Diagnostic Ultrasound Systems, enhancing automated assessment of left ventricular function and ejection fraction. The updates, confirmed as substantially equivalent based on retrospective non-clinical performance data, aim to improve diagnostic capabilities for trained healthcare professionals across a wide range of human body applications.

Philips Ultrasound LLC has enhanced its EPIQ and Affiniti Series Diagnostic Ultrasound Systems by integrating Segmental Wall Motion (SWM) v2 and AI-based Auto EF with contrast software. The SWM v2 software automates the evaluation of segmental left ventricular function from adult transthoracic echo examinations, while the Auto EF with contrast feature aids clinicians in assessing Left Ventricular Ejection Fraction from contrast-enhanced images. These systems are intended for broad diagnostic ultrasound imaging and fluid flow analysis across various human body applications, including cardiac, abdominal, and musculoskeletal, to be utilized by trained healthcare professionals in diverse clinical settings. The updated ultrasound systems, with no hardware changes, were determined to be substantially equivalent for their intended uses following a review of non-clinical performance data, including retrospective data analysis studies. These studies demonstrated acceptable performance for both SWM v2 and Auto EF with contrast, aligning with previously assessed algorithms and raising no new safety or effectiveness concerns. The manufacturer is expected to adhere to ongoing regulatory requirements such as annual device registration, good manufacturing practices, proper labeling, and compliance with Quality System and Unique Device Identification System rules.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. What specific clinical benefits are expected from the improved accuracy or automation provided by SWM v2 and Auto EF with contrast, particularly in challenging cardiac cases?; How do the AI algorithms in Auto EF with contrast handle variations in image quality or contrast agent kinetics, and what are their limitations in atypical patient populations?; Are there specific training requirements or best practices recommended for clinicians to maximize the diagnostic utility of the new SWM v2 and Auto EF features?; Beyond the non-clinical retrospective data, have there been any prospective clinical trials or real-world evidence studies initiated to further validate the performance of these new features?; How do the new SWM v2 and Auto EF with contrast features compare in performance and workflow integration to similar technologies offered by competitors in the diagnostic ultrasound market?