(31 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 requiatory requirements.
I am sorry, but the provided text from the 510(k) summary for Xenform™ Soft Tissue Repair Matrix does not contain information about acceptance criteria or a study proving that the device meets such criteria. The document focuses on device description, intended use, and claiming substantial equivalence to legally marketed devices based on technological characteristics and biocompatibility.
Therefore, I cannot fulfill your request for the specific details outlined (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study results, standalone performance, ground truth types, or training set information).
The text only states that:
- Biocompatibility Assessment: "A rigorous biocompatibility assessment performed by an independent certified laboratory demonstrated the biocompatibility of Xenform."
- Manufacturing Methods: "The manufacturing methods for Xenform were also tested by an independent laboratory to assure safe levels of viral inactivation."
However, it does not provide any quantitative acceptance criteria or results from these assessments.
§ 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.