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HepaFatSmart® Product Specifications
Sensitivity and Specificity
The diagnostic accuracy of HepaFatSmart® for predicting HepaFatScan® steatosis grading has been tested prospectively on over 1,000 scans 1 . The table indicates the sensitivities and specificities of HepaFatSmart® for predicting steatosis grades as evaluated by the FDA approved and validated HepaFatScan® method 2, 3.
| Steatosis Grades | Grade ≥ 1 | Grade ≥ 2 | Grade = 3 |
|---|---|---|---|
| Sensitivity (95% conf interval) | 1.00 [0.97 – 1.00] | 0.98 [0.93 – 0.99] | 1.00 [0.93 – 1.00] |
| Specificity (95% conf interval) | 0.98 [0.94 – 0.99] | 0.98 [0.94 – 0.99] | 0.99 [0.97 – 0.99] |
References
1. FDA 510(k): K231459
2. St. Pierre, et al. (2016) PLoS ONE, 11: e0160789
3. Vos, et al. (2020) GastroHep, 2: 171.
Technical Specifications
Technology
3 point Dixon
HepaFat-AI training
Using 889 individual HepaFat-Scan datasets from both 1.5T and 3T scanners
Evaluation
Volumetric liver fat fraction (VLFF)
Longitudinal monitoring capability
Yes
Patient age groups
All excluding neonates
Results generated
In real time
Data acquisition time
2 minutes
Breathhold requirements
Yes
Contrast agents
None
Slices
3
Data transfer and report delivery system
Via HIPPA &
GDPR compliant secure portal system
GDPR compliant secure portal system Scanner compatibility
Compatible on 1.5T & 3T machines, including 
,
, General Electrics and 
others.
,, General Electrics and others. Software requirements
None
Hardware requirements
None specific as long as the required imaging protocol can be achieved
MRI scanner validation
With saline bag Quality assured certification
ISO 13485:2016
Clearances
FDA 510(k) cleared • 
• ARTG included