Annalise Enterprise CXR Triage Pneumothorax

Evidence summary

Study type: Stand-Alone Performance. Cases: 949. Reference standard: Interpretation by Reviewing Clinician. Reported sensitivity: Pneumothorax: 93.9% (95% CI: 91.8%, 96.1%) Tension Pneumothorax: 94.3% (95% CI: 90.2%, 98.4%). Reported specificity: Pneumothorax: 92.2% (95% CI: 89.9%, 94.4%) Tension Pneumothorax: 95.8% (95% CI: 94.3%, 97.1%). Additional reported metrics: Performance assessed at multiple operating points, refer to Performance Guide

Public source Exact FDA submission Checked 2026-09-01

Structured study metadata from the exact-submission ACR model card; this is not an independent evidence synthesis.

• 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 K213941. 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 K213941 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 and recall packets were prepared and identity matched, but no new clinical or performance claim was promoted in the conservative fallback. Existing exact-submission facts retain their original source status and applicability; candidate literature remains quarantined. 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 K213941: Annalise Enterprise CXR Triage Pneumothorax U.S. Food and Drug Administration · 2026-09-09
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• Annalise CXR - Pneumothorax / Tension Pneumothorax model card (K213941) 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 K213941 U.S. Food and Drug Administration · 2026-09-09