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The EZ Plate™ cervical plate system is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

The EZ Plate™ cervical plate system consists of self-tapping/self-drilling screws and plates. Screws are available in a variety of diameter and length combinations. Plates are available in a variety of lengths.

The provided document is a 510(k) premarket notification for a medical device called the "EZ Plate™ cervical plate system." It describes the device, its intended use, materials, and provides a comparison to predicate devices. However, this document does not contain information about a study involving AI or software for diagnostic purposes, nor does it provide acceptance criteria or performance data for such a study.

The "Performance Data" section in the document refers to mechanical testing (static compression bending, torsion, and dynamic compression bending) performed according to ASTM F1717. This testing is for the physical device (cervical plate system) to demonstrate its mechanical properties and equivalence to predicate devices, not for evaluating software or AI performance in a diagnostic or clinical setting.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving a device (AI/software) meets those criteria based on the provided text. The document is about a physically implanted medical device, not a diagnostic AI system.

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