(172 days)
This device is intended for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, prolapse repair, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is intended for one-time use.
XYLOS™ Surqical Mesh is prepared from microbial derived cellulose that undergoes chemical processing inclusive of solvent dehydration. Units are cut in various sizes to meet surgical needs. Each unit is double-pouched, labeled, and gamma sterilized surgical mesh exhibits excellent tensile strength, suture retention and consistent thickness.
The provided document (K023237) is a 510(k) summary for a surgical mesh, which is a medical device and not an AI/ML powered device. As such, the requested information about acceptance criteria, study design elements relevant to AI/ML performance (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) is not applicable or present in this document.
The document discusses the performance data in a general sense, stating:
"XYLOS™ Surgical Mesh functions as intended when subjected to safety, biocompatibility, toxicity, pyrogenicity, sterility and mechanical strength testing."
However, it does not provide specific acceptance criteria or detailed results from these tests. It merely states that the device meets them.
Therefore, I cannot populate the table or provide the detailed information requested in points 1-9 as this type of information is not included in the provided 510(k) summary for a traditional medical device like a surgical mesh.
§ 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.