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The FortiBridge™ Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2 to T1). The system is to be used as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

The FortiBridge™ System consists of implants and instruments for implantation. It is an anterior cervical plate and screw system which includes fixed and variable screws having standard, self-drilling or self-tapping tips, and one- through four-level plates. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient. The devices are sold sterile.

This document does not contain information about acceptance criteria or a study proving a device meets acceptance criteria in the context of an AI/ML medical device.

The provided text is a 510(k) premarket notification for the FortiBridge® Anterior Cervical Plate System, which is a physical spinal implant. The document details the device's indications for use, materials, and substantial equivalence to previously cleared predicate devices.

Specifically, page 5 states: "Performance data was not provided in this submission." This indicates that the submission relies on substantial equivalence to predicate devices rather than new performance data to demonstrate safety and effectiveness.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

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