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The NuVasive X-CORE® Expandable VBR System is a vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The NuVasive X-CORE Expandable VBR System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.

The X-Core® Expandable VBR System is manufactured from Ti-6A1-4V ELI conforming to ASTM F136 and ISO 5832-3. The implants are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient. This 510(k) covers design changes to NuVasive Expandable Lumbar Interbody System (K090176).

This document is a 510(k) premarket notification for a medical device (NuVasive X-CORE® Expandable VBR System). It asserts substantial equivalence to predicate devices based on non-clinical testing. It does not describe a study involving "acceptance criteria" and "device performance" in the way one would for an AI/CADe/CADx device that performs a diagnostic or predictive function.

Therefore, I cannot extract the requested information as it pertains to AI/CADe/CADx studies. The document describes a physical medical device (vertebral body replacement system) and its performance is evaluated through mechanical testing, not through analysis of data in the way an AI algorithm would be.

Specifically, the document states under "G. Performance Data": "Nonclinical testing was performed to demonstrate that the subject NuVasive X-CORE Expandable VBR System is substantially equivalent to other predicate devices... The results demonstrate that the subject NuVasive X-CORE Expandable VBR System is substantially equivalent to predicate devices. No non-clinical studies were conducted." This last sentence appears to be a typo, likely intending to say "No clinical studies were conducted" given the preceding description of nonclinical testing.

If you are looking for information about AI/CADe/CADx device studies, this document is not relevant.

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