Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System

The Philips EPIQ and Affiniti Diagnostic Ultrasound Systems are enhanced with a new Liver Fat Quantification software module designed to provide quantitative metrics for liver fat assessment. This module employs two distinct methods: Attenuation Quantification, which measures the rate of ultrasound signal decay in liver tissue (attenuation coefficient), and Hepato-Renal Index Quantification, which calculates a comparative echogenicity ratio between the liver and kidney, to aid in the non-invasive evaluation of hepatic steatosis.

The Philips EPIQ and Affiniti Diagnostic Ultrasound Systems are intended for diagnostic ultrasound imaging and fluid flow analysis across a wide array of human body applications, including abdominal, cardiac (adult, fetal, pediatric), vascular, fetal/obstetric, gynecological, musculoskeletal, and small organ imaging, among others. These systems are designed for use by trained healthcare professionals in clinical environments such as clinics, hospitals, and at the point-of-care. The purpose of this update is to introduce two new software features for Liver Fat Quantification, enhancing the capabilities of these ultrasound platforms for assessing liver conditions. The new Liver Fat Quantification module comprises two distinct software features: (1) Attenuation Quantification, which measures the attenuation coefficient of ultrasound in dB/cm-MHz within a specified region of interest in the liver, and (2) Hepato-Renal Index Quantification, which calculates a ratio measure of the echogenicity (ultrasound brightness) of the liver parenchyma relative to that of the adjacent renal cortex. These new tools supplement existing liver quantification capabilities on the systems, such as Shear Wave Point Quantification (ElastPQ) and Shear Wave Imaging (ElastQ), which measure liver stiffness. The performance of these new fat quantification features was evaluated through Philips' internal design control processes, including requirements review, risk analysis, software verification and validation, and non-clinical bench performance testing against a reference device with similar functionalities.

AI Regulatory Concerns

Powered by

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

• Q1. What is the diagnostic accuracy of the Attenuation Quantification and Hepato-Renal Index features in detecting and staging hepatic steatosis compared to established methods like MRI-PDFF or liver biopsy?; How do patient-specific factors such as Body Mass Index (BMI), skin-to-liver distance, or the presence of co-existing liver conditions (e.g., fibrosis, inflammation) affect the reliability and accuracy of these liver fat quantification measurements?; What are the specific cut-off values for the Attenuation Coefficient (dB/cm-MHz) and Hepato-Renal Index that correlate with different grades of liver steatosis, and how were these thresholds validated across diverse patient populations?; How does the integration of these new fat quantification features into the Philips EPIQ and Affiniti systems impact overall workflow efficiency and examination time for abdominal ultrasound procedures specifically targeting liver assessment?; Are there any known technical limitations or contraindications for using these specific liver fat quantification software features, and how do they compare in performance to similar quantification tools available on other ultrasound systems?