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The VADER® Pedicle System:

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-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 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 fenestrated VADER® pedicle screws augmented with G21V-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., spondylodiscitis) 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.

VADER®one Pedicle System:

The VADER ®one 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.

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

The purpose of this Traditional 510(k) is to seek marketing clearance for the VADER® Pedicle System and VADER®one Pedicle System with additional connector components. The VADER® Pedicle System and VADER®one Pedicle System are posterior pedicle systems manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of:

• Polyaxial cannulated, fenestrated pedicle screws,
• Polyaxial, cannulated, pedicle screws, ●
• Curved. straight. S-rods. J-rods. ●
• Connectors .

The VADER® Pedicle System and VADER®one Pedicle System can be used for single or multiple level fixations in the non-cervical spine.

Based on the provided text describing the VADER® Pedicle System and VADER®one Pedicle System, it's clear this document is an FDA 510(k) clearance letter for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct clinical effectiveness of a new technology.

Therefore, the document does not contain the kind of information requested regarding acceptance criteria, performance studies involving AI, human readers, ground truth establishment, or sample sizes related to AI/algorithm development. The performance testing mentioned is confined to "Bench testing consisting of static axial gripping capacity testing and static torque gripping capacity per ASTM 1798 and dynamic compression bending per ASTM F1717 was successfully completed," which are mechanical performance tests, not clinical or AI-related studies.

In summary:

• There is no mention of acceptance criteria and reported device performance related to an AI/software component. The "acceptance criteria" discussed implicitly by the FDA in a 510(k) context are those for establishing substantial equivalence to a predicate, primarily through material, design, and mechanical performance comparisons.
• There is no data regarding a "test set" for an AI or imaging algorithm. The "study" described is bench testing of the pedicle system's mechanical properties.
• No experts, ground truth, or adjudication methods are discussed in the context of clinical AI performance.
• No MRMC comparative effectiveness study or standalone algorithm performance is described.
• The type of ground truth used is not applicable as this is not an AI/imaging device. The "ground truth" for this device would be its physical properties meeting standards and its successful mechanical performance.
• No training set for an AI algorithm is mentioned.
• Ground truth for a training set is not applicable.

This document pertains to the market clearance of a pedicle screw system, primarily based on its mechanical performance and substantial equivalence to existing devices, not on the performance of an AI or imaging diagnostic algorithm.

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