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The Precision Surgery Limited Fixed, Variable and Corpectomy Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The Precision Surgery Limited Fixed, Variable and Corpectomy Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The Precision Surgery Limited Fixed, Variable & Corpectomy Cervical Plate System comprises plate and screw components in a variety of sizes and lengths. Three styles of plate, including fixed, variable and corpectomy, are available. Primary, self-drilling primary and rescue screws are offered.

The provided text is a 510(k) summary for the "Fixed, Variable & Corpectomy Cervical Plate System." This document describes a medical device, specifically a spinal implant, and seeks substantial equivalence to a predicate device. It does not present a study with acceptance criteria and reported device performance in the context of an "AI" or "diagnostic" device. Instead, it describes a traditional medical device (a cervical plate system) and its substantial equivalence to a previously cleared device based on design, intended use, indications, anatomic sites, and performance (which likely refers to mechanical and biocompatibility testing, not clinical performance metrics in the way a diagnostic device would have).

Therefore, I cannot fulfill the request for information regarding acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the type of device and submission described in the provided text.

The closest information provided is regarding the overall device description and its intended use, which are established for mechanical devices through different types of testing (e.g., biomechanical, material characterization) rather than clinical performance studies with diagnostic metrics.

If this were a diagnostic device, I would expect to see details about sensitivity, specificity, accuracy, or other relevant performance metrics, along with the study design to evaluate these. As that is not the case here, I can only extract information that is present.

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