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The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.

The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 are posterior pedicle systems manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of polyaxial pedicle screws and curved, straight and J-rods. The VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 can be used for single or multiple level fixations in the non-cervical spine.

I am sorry, but the provided text does not contain the detailed information needed to describe the acceptance criteria and the study that proves the device meets them in the format you requested.

Specifically, the document is an FDA 510(k) clearance letter and summary for a pedicle screw system. While it mentions "performance testing summary" and "engineering rationales for mechanical testing, biocompatibility assessment, and clinical evidence" to demonstrate substantial equivalence, it does not provide the specific acceptance criteria, reported device performance metrics against those criteria, details of a study (like sample size, data provenance, ground truth establishment, or expert involvement), or any information about AI assistance or standalone algorithm performance.

Therefore, I cannot fulfill your request for items 1 through 9.

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