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The KASILOF Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion from levels C2 through T1 of the cervical spine. The system is indicated for use in the stabilization of the anterior cervical spine during the development of cervical spinal fusion in patients. The indications include spinal stenosis, degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,), tumors, deformity (defined by kyphosis, lordosis, or scoliosis), and/or pseudarthrosis (defined as failed previous fusion).

The KASILOF Cervical Plate System is a plate and screw system composed of medical grade titanium Ti-Alloy (Ti-6A-I4V ELI) components. The titanium plates are available in a variety of lengths, addressing multiple levels of fixation. The plates contain an integrated locking mechanism which interfaces with fixed and variable angled screws, of various diameters and lengths, to accommodate anatomical variation when securing the plate-screw construct to the anterior cervical vertebral bodies. The system is intended to provide mechanical support to the implanted level(s) until fusion is achieved. To accommodate normal cervical spine lordosis, and at the same time eliminate the need for additional plate contouring, KASILOF Cervical Plates come with a pre-lordosed curve. Various instruments are available to facilitate the implantation of the device.

This document describes a 510(k) premarket notification for the KASILOF Cervical Plate System. A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing de novo clinical study data with detailed acceptance criteria and performance metrics for a novel AI/software device.

Therefore, the requested information regarding acceptance criteria, study that proves the device meets the acceptance criteria (including sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details) is not present in this document.

This document describes a medical device (a cervical plate system), not a software or AI device. The "Performance Testing" section refers to bench performance testing (Static Compression, Static Torsion, and Dynamic Compression) against an ASTM standard (ASTM F1717-18) for the physical device, and not a study validating AI performance. The conclusion states that the device is substantially equivalent based on these test results and comparison to predicate devices.

To answer your request, if this were an AI/software device submission, the relevant sections would typically describe a clinical validation study or performance testing study addressing algorithm output against a ground truth. None of that information is contained within this 510(k) notification for a physical spinal implant.

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