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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.

The XYLOS Surgical Mesh will function as a non-absorbable surgical biomaterial that enables rapid fixation by tissue incorporation. The device incorporates a microporous structure that ensures early fixation to host tissue with minimal foreign body response. The double-pouched, sterile, single use unit is designed to allow maintenance of the sterile field prior to implantation. The material is conducive to size with sterile surgical instruments to avoid excessive tension on the suture line.

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria. Instead, it is a 510(k) summary for the XYLOS Surgical Mesh, primarily discussing its substantial equivalence to a previously cleared device.

Therefore, I cannot fulfill the request to provide the detailed information about acceptance criteria and a study as requested in the prompt.

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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.

Ask a specific question about this device