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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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