(37 days)
Xenform Soft Tissue Repair Matrix is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of colon, rectal, urethral, and vaginal prolapse; reconstruction of the pelvic floor; and procedures such as sacrocolposuspension and urethral sling.
Xenform Soft Tissue Repair Matrix is an acellular collagen material intended to be utilized for surgical procedures pertaining to the pelvic floor. Xenform Soft Tissue Repair Matrix is supplied sterile and provided in sheet form in a variety of sizes to be trimmed and sutured by the surgeon to meet the individual patient's needs. Xenform Soft Tissue Repair Matrix is manufactured from bovine skin, one of the purest sources of collagen available. The source material is solely derived from cattle obtained in compliance with US and European regulatory requirements.
The provided text is a 510(k) summary for a medical device (Xenform Soft Tissue Repair Matrix) and does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.
Instead, this document focuses on demonstrating that the device is "substantially equivalent" to a previously marketed predicate device (also named Xenform, K051190) based on its design, intended use, technological characteristics, and biocompatibility.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance), or training set information. The document primarily describes the device, its intended use, and its equivalence to a predicate, along with a summary of biocompatibility testing. It doesn't detail a study designed to measure specific performance outcomes against predefined acceptance criteria for the new 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.