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The Prase-C 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-C 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. The plates are offered in one-level, two-level, three-level, four-level, five-level fusion configurations. In addition, one level plate consists of a four hole for screw insertion and a two-hole and three-hole for screw insertion. 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 based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria with the requested details.

The document is an FDA 510(k) clearance letter for a medical device called the "Prase-C Anterior Cervical Plate System." While it mentions "Performance Testing" according to ASTM F1717, it does not provide any specific acceptance criteria (numerical values or performance thresholds) nor does it report detailed device performance data (e.g., specific loads applied, displacements, or number of cycles achieved).

In essence, the document confirms that the device was tested per a standard and found to be "substantially equivalent" to predicate devices, but it does not disclose the actual test results or the pre-defined target values for those results.

Therefore, I cannot populate the table or provide the requested information regarding sample size, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details, as this information is not present in the provided text.

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