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The REX Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include:

degenerative disc 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.

Rex Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, sub-plate, rivets and the associated instruments. The sub-plate is pre-assembled to the main plate and designed to prevent screws from backing out using the elastic behavior during the screw insertion. The rivets are also pre-assembled to the main plate and designed to assemble the sub-plate to the main plate firmly. 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, two, three, and four level procedures. Main plate are available from 20mm to 110mm. Screws are available in lengths from 10mm to 20mm in 2mm increments. The screws have either a 3.5mm or 4.0mm diameter. They are fixed self-tapping, Variable self-tapping screw, fixed self-drilling screw, Variable self-drilling and are available in lengths ranging from 10mm to 20mm in 2mm increments

The Rex Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F 136.

The provided text is a 510(k) summary for the Rex Anterior Cervical Plate System. It describes the device, its intended use, and its performance data, primarily focusing on its substantial equivalence to predicate devices.

However, the document does not contain information related to a study proving the device meets acceptance criteria in the context of AI/ML performance, such as sensitivity, specificity, or F1 score. The performance data mentioned refers to mechanical tests (static compression, torsion, and fatigue) performed according to ASTM F1717 to characterize the physical properties of the cervical plate components.

Therefore, I cannot fulfill the request for information on acceptance criteria and study details related to AI/ML device performance. The document focuses on regulatory approval for a physical medical device based on material, design, and operational principles, and substantial equivalence to existing predicate devices.

Here's what I can extract from the provided text, acknowledging the lack of AI-specific performance data:

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding the other requested information, there is no mention in the provided text for:

• Sample size for the test set or training set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications for ground truth establishment.
• Adjudication method for the test set.
• MRMC comparative effectiveness study or effect size of AI assistance.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for any AI/ML model.
• How ground truth for the training set was established.

This document is a 510(k) summary for a spinal implant, which is a hardware device, not an AI/ML software device. The "performance data" refers to the physical and mechanical characteristics of the plate system.

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