See-Mode Augmented Reporting Tool, Thyroid (SMART-T)

Evidence summary

FDA performance testing included a standalone study and an MRMC reader study with 600 unique patients/cases and 18 board-certified radiologists. For localization at IoU greater than 0.5, average reader AUC was 0.758 aided, 0.736 unaided, and standalone AUC was 0.703 (95% CI 0.642-0.762). Reader localization accuracy was 95.6% aided, 93.6% unaided, and 95.1% standalone. Standalone descriptor accuracy was 86.7% composition, 68.2% echogenicity, 93.4% shape, 58.4% margin, and 70.3% echogenic foci; standalone overall TI-RADS-level agreement was 63.8% (95% CI 60.0-67.7). Ground truth used FNA or two-year follow-up for benign/malignant status and expert radiologist consensus with adjudication for localization and descriptors.

• FDA source
• Exact FDA submission
• Checked 2026-09-08

• 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 K240697. 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 2026-09-08

• Source

• Verify deployment and data flow: The reviewed sources do not establish the current exact-release hosting topology, data flow, region, tenancy, or disaster-recovery configuration.
• 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 K240697 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