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Additional indications for the OSStaple™ are: For use in conjunction with traditional rigid fixation in cervical fusion procedures as a means to maintain the relative position of bony tissue such as allografts. This device is for use with traditional rigid fixation devices such as the Ransford Loop, Hartshill rectangles, cerclage wiring or other legally marketed cervical spine stabilization device. This device is not intended to be used alone for load bearing applications.

The OSStaple™ Staple system consists of two prong staples fabricated from Nitinol. The staple's prongs are parallel during insertion. Application of an electrical current from the OSSforce™ Controller to the staple causes the staple prongs to deflect inward and the "S" shaped back to contract until constrained. This inward deflection and contraction causes staple retention. This device is for use with traditional rigid fixation devices such as the Ransford Loop, Hartshill rectangles, cerclage wiring or other legally marketed cervical spine stabilization device.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance as requested in your prompt. The document is a 510(k) summary for the OSStaple™ Staple System, detailing its intended use, device description, and substantial equivalence to predicate devices, and the FDA's decision letter. It does not include specific performance studies or acceptance criteria for those studies.

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