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Rotium® is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Rotium® is composed of two types of polymer fibers: Poly(lactide-co-caprolactone) (PLCL) and Polyglycolic acid (PGA). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. Rotium® is conformable and designed for easy placement between the tendon and surrounding tissue and may be secured in place using standard fixation techniques. Rotium® is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, ranging from 20mm x 20mm to 70mm x 25mm. Rotium® is designed for stand-alone use. At the discretion of the surgeon, Rotium® may be hydrated with sterile isotonic solution.

The provided text is a 510(k) premarket notification for a medical device called Rotium®, a surgical mesh for tendon injuries. It does not contain information about an AI/ML-driven medical device, nor does it detail a study proving such a device meets acceptance criteria.

The document primarily focuses on demonstrating substantial equivalence of the Rotium® surgical mesh to a predicate device based on its material composition, physical and mechanical properties, biocompatibility, and animal testing.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI/ML device meets them, as the provided text pertains to a different type of medical device (surgical mesh) and its traditional regulatory submission.

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