ProFound Detection (V4.0)

Evidence summary

FDA K240417 reports a primary non-inferiority/paired comparison and standalone performance results in the same independent-data discussion. The standalone dataset contains 952 cases, including 251 biopsy-proven cancer cases with 256 malignant lesions and 701 non-cancer cases. V4.0 using priors reported sensitivity 0.9004, specificity 0.6205, and AUC 0.8753; V4.0 without priors reported 0.9004, 0.5863, and 0.8714; the predicate V3.0 reported 0.8725, 0.5278, and 0.8230. The data were retrospectively collected from U.S. image-acquisition sites and used established clinical reference standards.

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 K240417. 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 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 K240417 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 K240417: ProFound Detection (V4.0) U.S. Food and Drug Administration · 2026-09-08
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• ProFound Detection (V4.0) model card (K240417) 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 K240417 U.S. Food and Drug Administration · 2026-09-08