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The system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: Degenerative Disc Disease, Trauma, Spinal Stenosis, Cervical myelopathy, Deformities or Curvatures, Tumor, Pseudoarthrosis, and failed previous fusion.

The Met One Czar Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The Met One Czar Anterior Cervical Plate System includes screws, plates, and a set of instruments to insert the implants. Plates are available in a variety of lengths to accommodate fusion procedures from one to four levels of the cervical spine. Fixation is achieved by inserting the screws through the openings in the plate into vertebral bodies of the cervical spine. Met One Czar plates are manufactured from Titanium 6A1-4V ELI per ASTM F136 and Invibio PEEK-OPTIMA™ LT1 per ASTM F2026.

This document describes a spinal intervertebral body fixation orthosis, specifically the Met One Czar Anterior Cervical Plate System. It is a 510(k) premarket notification for a Class II medical device. As such, the information provided focuses on demonstrating substantial equivalence to legally marketed predicate devices through design, material, and functional comparisons, along with mechanical testing. It does not contain the kind of clinical study details, acceptance criteria tables, expert ground truth adjudication, or human-AI reader studies typically found for AI/ML-driven diagnostic devices.

Therefore, I cannot extract the information required by your request about acceptance criteria and a study proving the device meets those criteria, specifically concerning AI/ML performance.

Here's why:

• Device Type: The Met One Czar Anterior Cervical Plate System is a physical implant (spinal plate and screws), not a diagnostic software or AI/ML algorithm.
• Regulatory Pathway (510(k)): For this type of device and regulatory pathway, the primary demonstration of safety and effectiveness relies on showing "substantial equivalence" to existing, legally marketed predicate devices, often supported by bench testing (mechanical, material properties) and design comparisons. It does not typically involve clinical trials with human readers, AI assistance, or complex ground truth establishment in the way an AI diagnostic device would.
• Information Provided: The document details the device description, intended use, technological characteristics, and notes that substantial equivalence is supported by mechanical testing (static and dynamic compression, static torsion per ASTM F1717). There is no mention of an algorithm, image analysis, diagnostic performance, or human-in-the-loop studies.

In summary, the provided document does not contain the information necessary to answer your questions regarding acceptance criteria, AI/ML device performance studies, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies because the device described is a physical implant, not an AI/ML diagnostic tool.

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