StrokeSENS ASPECTS Software Application

Evidence summary

FDA standalone validation used 200 NCCT scans from acute ischemic stroke patients with confirmed ICA/MCA occlusion. Region-level clustered ROC analysis reported AUC-ROC 90.9% (95% CI 88.7%-93.1%), accuracy 90.6% (95% CI 89.7%-91.5%), sensitivity 70.6% (95% CI 69.2%-72.1%), and specificity 93.9% (95% CI 93.2%-94.7%). A separate 100-scan MRMC reader study with eight readers reported aided versus unaided AUC 74.3% versus 68.6%, sensitivity 51.0% versus 41.3%, specificity 97.5% versus 95.9%, accuracy 92.0% versus 89.5%, and Fleiss kappa 60.8% versus 32.3%; VCTA concordance was 97.0%.

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 K250221. 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 K250221 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 K250221: StrokeSENS ASPECTS Software Application U.S. Food and Drug Administration · 2026-09-08
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• StrokeSENS ASPECTS Software Application model card (K250221) 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 K250221 U.S. Food and Drug Administration · 2026-09-08