(193 days)
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.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.