HepaFatSmart (V2.0.0)
Resonance Health Analysis Services Pty LtdHepaFatSmart (V2.0.0) is an automated AI-assisted software that analyzes magnetic resonance imaging (MRI) datasets to measure liver fat quantitatively. It calculates volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF), and steatosis grading without user input, supporting clinical diagnosis and management of fatty liver disease and screening of liver transplant donors. This software helps clinicians by providing consistent, reproducible liver fat measurements from MRI scans, aiding patient care in liver-related conditions.
Intended Use
HepaFatSmart is intended for quantitative measurement of volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF), and steatosis grading using MRI.
Technology
HepaFatSmart is a cloud-based or onsite AI-assisted software that takes DICOM MRI datasets acquired via a specific GRE protocol; employs a convolutional neural network (CNN) for liver ROI detection; applies algorithmic modules to compute Alpha, VLFF, PDFF, steatosis grade, and assesses liver iron content; generates PDF and DICOM reports with quantitative fat measurements and quality images.
Performance
Performance evaluated via repeatability and validation studies (n=42, n=300) showed HepaFatSmart has excellent agreement and substantial equivalence with predicate HepaFat-Scan for liver fat fraction measurement, with improved repeatability and specificity/sensitivity over predicate HepaFat-AI. Clinical thresholds for steatosis grades were accurately predicted with sensitivities and specificities above 90%.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/19/2023
1 month - 2
FDA Approval
6/20/2023
Other devices from Resonance Health Analysis Services Pty Ltd
- LiverSmart2021 • 510K
- HepaFat-AI2020 • 510K
- FerriSmart Analysis System2018 • 510K
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