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The Skyway Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the following indications: 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), spinal stenosis, deformity (i.e., kyphosis, lordosis), tumor, pseudarthrosis or failed previous fusion. The 4-Hole 1-Level Plates are limited to use at one contiguous level.

The KMTI Tesera-K SC System is indicated for intervertebral body fusion procedures in skeletally mature patients with cervical degenerative disc disease at one or two levels from C2-T1 . KMTI Tesera-K SC System implants are to be used with autogenous bone graft. Patients should be skeletally mature and have at least six weeks of non-operative treatment prior to implantation. When used with the Skyway Anterior Cervical Plate System plates designed with spacer attachment, the assembly takes on the indications of the KMTI Tesera-K SC Interbody Spacer, with the Skyway Anterior Cervical Plate System acting as the supplemental fixation.

The Kyocera Medical Technologies, Inc. (KMT) Skyway Anterior Cervical Plate System consists of anterior cervical plates, bone screws, and a locking screw. The implant components are composed of titanium alloy Ti-6A1-4V ELI per ASTM F136. The Skyway Anterior Cervical Plate System is offered in various sizes to accommodate patient anatomical needs. The subject 1-Level plates are compatible with and may be permanently attached to the Tesera-K SC System interbody spacers.

I am sorry, but the provided text does not contain information about an AI/ML-driven medical device, its acceptance criteria, or a study proving its performance.

The document is a 510(k) premarket notification for the Kyocera Medical Technologies, Inc. (KMTI) Skyway Anterior Cervical Plate System, which is a spinal intervertebral body fixation orthosis. It discusses the device's indications for use, technological characteristics, and performance data based on mechanical testing (e.g., static and dynamic compression bending, static torsion).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the document does not describe such a study for an AI/ML device.

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