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Properly used in conjunction with traditional rigid fixation, this system is intended for use in spinal fusion procedures as a means to maintain the relative position of weak bony tissue such as allografts or autografts. This device is not intended for load bearing indications.

The GAPP™ Graft Containment Device consists of bone fixation devices used in spinal fusion procedures. The graft containment device is available in a wide range of sizes for use in maintaining the relative position of weak bony tissue such as bone grafts. The graft containment device implants maintain the stability of weak bony tissue during the healing period.

The provided text is a 510(k) summary for the GAPP™ Graft Containment Device. It states that "Documentation was provided which demonstrated the GAPP™ Graft Containment Device to be substantially equivalent to the MacroPore OS Implant."

This type of submission is a claim of substantial equivalence, which means the device is being compared to a "predicate device" that has already been cleared by the FDA. The 510(k) summary provided does not contain independent acceptance criteria for the GAPP™ device or a study proving that the GAPP™ device meets specific performance criteria through direct testing.

Therefore, I cannot provide the requested information because the document describes a substantial equivalence claim rather than a detailed performance study with explicit acceptance criteria. The information requested (such as sample size, ground truth, expert qualifications, etc.) would typically be found in a detailed clinical or performance study report, which is not present in this 510(k) summary.

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