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
MRI chronic cuff symptoms after a failed conservative trial and when surgery is genuinely under consideration — tear anatomy then changes the plan.
MRI characterizes rotator cuff tear size, retraction, and muscle quality — details that matter when operative repair is being considered after failed conservative care. Ordering MRI before a conservative trial, or without a surgical question, is low-value.
The AIIE synthesis above is ARKA-authored; the sources below are the underlying external literature.
British Journal of Sports Medicine · 2015doi:10.1136/bjsports-2014-094148
American College of Radiology · 2024