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The NuVasive Traverse Plate System is indicated for use as an adjunct to fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels, in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of:

1. Fracture (including dislocation and subluxation)
2. Tumor
3. Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
4. Scoliosis
5. Kyphosis
6. Lordosis
7. Spinal stenosis
8. Failed previous spine surgery

The Traverse Plate System consists of a variety of plates, screws, bolts, and locking nuts. Implant components can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. This 510(k) is for a line extension to the Traverse Plate System for an additional plate configuration and bolt size.

The provided document is a 510(k) summary for the NuVasive Traverse Plate System, a spinal implant. This document describes the device, its intended use, and its substantial equivalence to predicate devices. It does not present a study proving a diagnostic device meets acceptance criteria for an AI/ML medical device.

Therefore, I cannot extract the information required by your request about acceptance criteria and a study proving a device meets them. The performance data section for this spinal implant focuses on nonclinical testing (static and dynamic compression, and static torsion testing per ASTM F1717) to demonstrate substantial equivalence to predicate devices, not on the performance of a diagnostic AI/ML system.

To answer your request, I would need a document detailing a study designed to evaluate the performance of an AI/ML medical device against specific acceptance criteria.

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