HepaFat-AI is an AI-powered software that automatically analyzes MRI images of the liver to measure liver fat content. It helps clinicians assess fatty liver disease, monitor liver fat in patients undergoing weight loss, and screen liver transplant donors by providing quantitative and reproducible fat fraction results quickly without manual input.
Intended Use
HepaFat-AI is intended for quantitative measurement of the triglyceride fat fraction in magnetic resonance images of the liver, also known as volumetric liver fat fraction (VLFF).
Technology
HepaFat-AI uses a proprietary MRI acquisition protocol and AI-based image analysis software consisting of two convolutional neural networks—one predicting the alpha measurement and another for anomaly detection. The software includes algorithmic modules converting alpha to volumetric liver fat fraction, proton density fat fraction, and steatosis grade, producing an automated report with confidence intervals and reference images for clinical review.
Performance
Performance testing includes validation against a predicate device HepaFat-Scan (K122035) using anonymized clinical MRI data, showing comparable sensitivity, specificity, repeatability, and diagnostic accuracy for liver fat quantification. Analytical and clinical validation followed FDA and IMDRF guidelines for software as a medical device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/20/2020
7 months - 2
FDA Approval
12/7/2020
Other devices from Resonance Health Analysis Services Pty Ltd
- HepaFatSmart (V2.0.0)2023 • 510K
- LiverSmart2021 • 510K
- FerriSmart Analysis System2018 • 510K
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