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The Prase-AP Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization of the spine as an adjunct to fusions in patients with: · degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) - spondylolisthesis - · trauma (i.e. fractures or dislocations) - · tumors - · deformity (defined as kyphosis, lordosis, or scoliosis) - · pseudoarthrosis - · failed previous fusion - · spinal stenosis

The Prase-AP Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy Ti-6AI-4V ELI as per ASTM F136. These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, three-level, four-level, five-level fusion configurations. The plate lockers are fixed into the main plate body by rivet technique. The screw type consists of single and double thread and fixed and variable type. This device is supplied non-sterile.

I am sorry, but the provided text describes a 510(k) premarket notification for a medical device called the "Prase-AP Anterior Cervical Plate System." This document focuses on demonstrating substantial equivalence to a predicate device based on design, material, scientific technologies, and indications for use, along with performance testing for mechanical properties (Static compression bending, Static torsion, and Fatigue compression bending).

There is no information in the provided text regarding any study involving AI/ML, human readers, or the establishment of ground truth for diagnostic purposes. Therefore, I cannot generate a response that fulfills the requirements of your prompt, as the information simply isn't present in the document.

The document is purely about the physical characteristics and mechanical performance of an orthopedic implant, not about a diagnostic or image-analysis device that would require the type of studies you are asking about.

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