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FortaFlex™ Surgical Mesh is intended to be used for implantation to reinforce soft tissue including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement and reconstructive procedures. The device is also intended for reinforcement of the soft tissues which are repaired by suture or sutere anchors, limited to the supraspinatus, during rotator cuff repair surgery. The device is intended for one-time use.

FortaFlex Surgical Mesh consists of a multi-laminate sheet predominantly of Type I porcine collagen. The device is supplied in sheet form in sizes ranging from 5 x 5 cm to 12 x 36 cm in sterile double layer peelable packaging.

The provided text describes the FortaFlex™ Surgical Mesh, a Class II device intended for soft tissue reinforcement. The submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving device meets acceptance criteria, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The "Performance Data" section merely states: "FortaFlex Surgical Mesh was subjected to a panel of tests to assess biocompatibility, integrity, and performance. The device passed the requirements of all tests." This is a high-level statement without any specific details of the tests, their acceptance criteria, or the actual results.

The 510(k) process focuses on demonstrating similarity to an already approved device. The FDA's letter confirms substantial equivalence, which means they believe the new device is as safe and effective as the predicate device(s) for the stated indications, based on similar technological characteristics, materials, and intended use as presented in the submission. It does not involve proving the device meets specific new performance acceptance criteria through the kind of study described in the prompt.

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