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The IMPEACE and IMPEACE-Uni Anterior Cervical Plate System is interior fixation to the cervical spine C2-C7. The specific clinical indications include:

• degenerative disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

The IMPEACE and IMPEACE-Uni Anterior Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, lock-plate and the associated instruments. The lock-plate is pre-assembled to the main plate and designed to prevent screws from backing out. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. The plates range in length to accommodate one and two-level procedures for IMPEACE-UNI and one, two, three, and four level procedures for IMPEACE. Main plate is available from 13mm to 46mm for IMPEACE-UNI and 10mm to 112mm for IMPEACE. Screws are available in lengths from 12mm to 20mm for IMPEACE-UNI and 10mm to 20mm in 2mm increments for IMPEACE. The screws have either a 4.5mm or 5.1mm diameter for IMPEACE-UNI and 4.0mm or 4.5mm diameter for IMPEACE. They are fixed self-tapping, variable self-tapping screw, fixed self-drilling screw, variable self-drilling. The IMPEACE and IMPEACE-Uni Anterior Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium allow (Ti-6Al-4V ELI) that conforms to ASTM F136.

This document is a 510(k) premarket notification for the IMPEACE and IMPEACE-Uni Anterior Cervical Plate System. It explicitly states that no performance testing was required for this submission. The basis for substantial equivalence is that the subject device is identical to a previously cleared predicate device (Huvexel - FORTIS and HANA Anterior Cervical Plate System, K173099).

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, study details (sample sizes, data provenance, expert panels, adjudication, MRMC studies, standalone performance), or how ground truth was established, as no such studies were conducted or provided in this documentation.

The document states:

• "The subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring name of a system that has already been cleared under K173099. No testing is required."
• "The IMPEACE and IMPEACE-Uni Anterior Cervical Plate System is identical to the predicate device and is as safe and effective as the Huvexel - FORTIS and HANA Anterior Cervical Plate System."

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