(55 days)
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.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.