ARKA Clinical Decision Support is designed to meet all four criteria for Non-Device CDS under FD&C Act §520(o)(1)(E) and FDA's January 2026 final guidance on Clinical Decision Support Software. Recommendations support, not replace, the clinician's judgment. Every recommendation is anchored in a published guideline or peer-reviewed source, with the basis available for independent review. CLIN emphasizes imaging appropriateness at order entry.
This recommendation is intended to support, not replace, clinical judgment. It is generated by ARKA, software designed to meet the four criteria for Non-Device Clinical Decision Support under FD&C Act §520(o)(1)(E) and FDA's final guidance on Clinical Decision Support Software (January 2026). The clinician is responsible for the final decision.
AIIE Evidence
Ottawa-negative ankle injuries need no X-ray — treat functionally and re-examine if not improving.
The Ottawa ankle rules identify patients whose acute ankle injury does not require radiography with near-perfect sensitivity for clinically significant fracture. Rule-negative patients can be managed functionally without films.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
BMJ · 2003doi:10.1136/bmj.326.7386.417
American College of Radiology · 2024