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The KINETIC®-SL Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in temporary stabilization of the anterior spine from C2 to T1 during the development of a cervical spinal fusion in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); (2) Spondylolisthesis; (3) Trauma (including fractures or dislocations); (4) Spinal cord stenosis; (5) Deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis); (6) Tumors; (7) Pseudarthrosis; (8) Failed previous fusions. Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The KINETIC® -SL Anterior Cervical Plate System consists of various sizes of anterior cervical bone plates and screws. Components are available in a variety of sizes to fit patient anatomy. All components are manufactured from implant grade titanium alloy 6A1-4V ELI per ASTM F-136. KINETIC®-SL Anterior Cervical Plate System components will be supplied clean and "NON-STERILE".

The provided document does not contain information regarding software or AI/ML device performance studies. Instead, it describes a medical device called the "KINETIC®-SL Anterior Cervical Plate System," which is a spinal implant. The document is a 510(k) summary for this physical medical device.

Therefore, I cannot provide the requested information about acceptance criteria and study details related to AI/ML device performance. The sections about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth are not applicable to the content of this document.

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