EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)

Evidence summary

Retrospective blinded multisite study of 300 consecutive US CTs, 139 positive and 161 negative, with three board-certified radiologists and majority reference. Mean processing time was 3.37 minutes in the study, not a service-level commitment.

FDA source Exact FDA submission Checked 2026-09-05

• Source

Postmarket safety review

Not established in reviewed sources

Reviewed sources checked Exact FDA submission Checked 2026-09-04

No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

• Verify deployment and data flow: Hosting and local network topology were not established.
• Verify security and privacy controls: No scoped dated security attestation reviewed.
• Verify training: Site triage escalation and notification training are unestablished.
• Verify pricing and total cost: No exact product price/procurement record reviewed.
• Verify reimbursement and coding relevance: No applicable payer policy reviewed.
• Verify local validation and lifecycle monitoring: Site audit of alert delivery and missed/false alerts requires confirmation.
• Verify recalls and postmarket safety signals: No native submission-identifier match was found in the checked openFDA radiology recall snapshot. Product-name, manufacturer, and adverse-event searches remain necessary; this does not establish that no recall or safety report exists.

Stored PubMed and clinical-trial arrays are empty and were screened. The current discovery snapshot contains 0 PubMed and 0 ClinicalTrials.gov candidate records; its dated, count-matched human screening remains current. Unlinked candidates remain quarantined. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads were screened against the exact product and tested version. Unlinked records remain quarantined.

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

• K253163 FDA decision source U.S. Food and Drug Administration · 2026-08-31
• Artificial Intelligence-Enabled Medical Devices U.S. Food and Drug Administration · 2026-08-31
• EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) model card (K253163) 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
• EFAI ERSUITE CT Appendicitis Assessment System: K253163 decision and 510(k) summary U.S. Food and Drug Administration · 2026-09-05
• Ever Fortune AI medical imaging solutions Ever Fortune.AI · 2026-09-06