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 acute knee injuries need no X-ray — manage symptomatically with re-evaluation if not improving.
The Ottawa knee rule (age ≥55, patellar or fibular head tenderness, inability to flex 90°, inability to bear weight) safely excludes fracture when negative, eliminating the need for acute radiographs.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
Annals of Internal Medicine · 2004doi:10.7326/0003-4819-140-2-200401200-00013
American College of Radiology · 2024