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The VADER® Pedicle System is 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.

When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time. The fenestrated VADER® pedicle screws augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The VADER® Pedicle System is intended to stabilize the thoracic and/or lumbar spine as an adjunct to fusion in patients with spinal infection (e.g., spondylodiscits, osteomyelitis) and spinal instability due to infection, surgical debridement, or decompression.

The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.

The VADER® Pedicle System is a posterior pedicle system manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of polyaxial pedicle screws and curved, straight, S-rods and J-rods as well as polyaxial, cannulated, fenestrated pedicle screws. The VADER® Pedicle System can be used for single or multiple level fixations in the non-cervical spine.

I am sorry, but the provided text is a 510(k) Premarket Notification from the FDA regarding a medical device called the "VADER® Pedicle System." This document is a clearance letter and a summary of the device's indications for use and substantial equivalence to a predicate device.

It does not contain any information about acceptance criteria, specific study designs, sample sizes for test or training sets, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies to assess device performance against specific metrics. The document states that "Clinical data was presented to support the expanded indications for use," and that this data "supports a substantially equivalent safety and effectiveness profile for the use of thoracolumbosacral pedicle screw instrumentation for the indications for use." However, it does not detail the nature of this clinical data or how it was used to establish performance against acceptance criteria.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them because that information is not present in the provided text.

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