HepaFatSmart (V2.0.0)

Evidence summary

The FDA packet reports a repeatability study of 42 paired subjects, with 41 used for HepaFatSmart after one high-iron case was rejected, and a validation study of 300 subjects in which 281 passed IQC. For VLFF values above 4.1%, sensitivity was 100.0% (95% CI 97.3%-100.0%) and specificity 98.6% (94.9%-99.6%); above 12.1%, sensitivity 98.8% (93.6%-99.8%) and specificity 98.0% (94.9%-99.2%); above 16.2%, sensitivity 100.0% (93.8%-100.0%) and specificity 99.6% (97.5%-99.9%). Bland-Altman bias, limits of agreement, and repeatability coefficients are separate quantitative-agreement endpoints.

FDA source Exact FDA submission Checked 2026-09-09

• Source

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Postmarket safety review

The exact-identifier FDA recall query returned no native recall record for K231459. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.

Public source Exact FDA submission Checked 2026-09-09

• Source

• Verify security and privacy controls: Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.
• Verify training: Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.
• Verify pricing and total cost: No public price or quote for the exact K231459 configuration was established in this review.
• Verify reimbursement and coding relevance: No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.
• Verify local validation and lifecycle monitoring: Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, acr ai central product, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall

• FDA K231459: HepaFatSmart (V2.0.0) U.S. Food and Drug Administration · 2026-09-09
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• HepaFatSmart (V2.0.0) model card (K231459) American College of Radiology · 2026-09-01
• PubMed biomedical literature index U.S. National Library of Medicine · 2026-09-01
• ClinicalTrials.gov study registry U.S. National Library of Medicine · 2026-09-01
• openFDA Device Recall API U.S. Food and Drug Administration · 2026-09-02
• openFDA exact recall query for K231459 U.S. Food and Drug Administration · 2026-09-09