EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

The Philips EPIQ and Affiniti Series Diagnostic Ultrasound Systems, augmented by the new "Auto ElastQ" software, are designed to enhance workflow efficiency and consistency in liver stiffness measurements. This is achieved through automated intelligent frame and Region of Interest selection leveraging 2D-Shear Wave Elastography (2D-SWE), which has demonstrated high agreement with manual measurements in non-clinical studies.

Philips Ultrasound LLC received regulatory clearance for its EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems, confirming their substantial equivalence for market use. These Class II devices are approved for broad diagnostic ultrasound imaging and fluid flow analysis across various body areas, leveraging ultrasonic pulsed Doppler imaging and adhering to general controls and existing regulations. The core of the submission introduced the "Auto ElastQ" software feature, designed to enhance workflow efficiency for liver stiffness measurements using 2D-Shear Wave Elastography (2D-SWE). This feature automatically recommends optimal frames and Region of Interest (ROI) positions, simplifying the measurement process. Non-clinical performance data, including a retrospective study, validated Auto ElastQ's safety and effectiveness by demonstrating high agreement with manual measurements without requiring hardware modifications.

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 are the specific clinical scenarios where the Auto ElastQ feature demonstrates the most significant workflow improvement and diagnostic benefit compared to manual measurements?; How does the automated frame and ROI selection algorithm of Auto ElastQ handle challenging cases, such as patients with significant liver heterogeneity or deep-seated lesions?; Are there any limitations or contraindications for using the Auto ElastQ feature, particularly concerning patient populations or specific liver pathologies?; Beyond the retrospective study, have prospective clinical trials been conducted or planned to further validate the long-term accuracy, reproducibility, and clinical impact of Auto ElastQ in diverse patient cohorts?; What is the training requirement for sonographers to effectively utilize and interpret results from the Auto ElastQ feature, and how does it compare to the skill set needed for traditional manual 2D-SWE measurements?