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The Athena Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of a solid spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions. The Athena Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

The Medyssey Athena Cervical Plate System is designed to provide mechanical support while biologic fusion takes place. The system consists of multiple plate sizes and screws to accommodate various patients' anatomy. The plates are available in fixed and variable forms to allow for fixed attachment or implantation at variable angles.

This document is a 510(k) Premarket Notification from the FDA regarding the "Athena Cervical Plate System." It confirms the device's substantial equivalence to previously marketed devices. However, it does not contain information related to an AI/ML medical device, nor does it discuss acceptance criteria and study results for such a device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document is for a mechanical spinal intervertebral body fixation orthosis and the performance metrics discussed are mechanical tests (e.g., bending, compression), not AI/ML performance metrics like accuracy, sensitivity, or specificity.

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