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The BowTi Anterior Buttress Staple System, in conjunction with traditional rigid fixation, 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 applications.

The BowTi Anterior Buttress Staple System consists of a staple and a screw. The staple is uniquely shaped to conform to the anatomy of the anterior spine. It features two prongs, which engage the vertebral body and prevent rotation, and a screw slot for final fixation. The staples have a 5-degree bend, and are available in two sizes, 20mm and 24mm. The self-tapping cancellous screws have a 6.25mm major diameter and are available in lengths of 20mm, 25mm, and 30mm. Both components of BowTi Anterior Buttress Staple System are the manufactured from titanium alloy and have a smooth anodized finish.

The provided text describes a medical device, the BowTi Anterior Buttress Staple System, and its 510(k) submission to the FDA. However, the document does not contain information related to acceptance criteria, specific device performance metrics, sample sizes for test or training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

The "Performance Data" section merely states: "Biomechanical testing, including static and fatigue cantilever beam loading, were conducted." This is a general statement and does not provide detailed results or acceptance criteria.

Therefore, I cannot fulfill the request for information on acceptance criteria and the study proving the device meets them because the necessary data is not present in the provided document.

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