(84 days)
The REGENETEN™ Bioinductive* Implant is indicated for the management and protection of tendon or extra-articular ligament injuries in which there has been no substantial loss of tendon or ligament tissue. * Bioinductivity has been demonstrated for tendon only.
The REGENETEN Bioinductive Implant Delivery System is indicated for the arthroscopic delivery of the REGENETEN Bioinductive Implant.
The REGENETEN™ Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons or ligaments. The implant is designed to provide a layer of collagen between a tendon or ligament and the surrounding tissue. After hydration, the implant is an easy-tohandle, pliable, nonfriable, porous collagen sheet. The REGENETEN Bioinductive Implant is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, in a dual sterile seal.
The provided text is a 510(k) summary for the REGENETEN™ Bioinductive Implant, focusing on demonstrating substantial equivalence to a predicate device for an expanded indication for use (inclusion of extra-articular ligament injuries). It does not describe an AI/ML device or its performance against acceptance criteria in the manner requested (e.g., sensitivity, specificity, MRMC study, expert ground truth adjudication).
Therefore, it is not possible to extract the requested information regarding acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes for test/training sets, expert qualifications, or details of MRMC studies and ground truth establishment, as this documentation pertains to a medical device (bioinductive implant) rather than a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool. The document details the device's physical characteristics, intended use, and the rationale for expanding its indications based on an animal study, not an AI model's performance.
To answer your request, I would need a 510(k) summary or similar regulatory document describing the validation of an AI/ML-powered medical device.
§ 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.