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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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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 is of insufficient duration to permit achievement of fusion.

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

The LightMore® Pedicle System 6.0 is indicated to provide the surgeon with an open approach for posterior spinal surgery.

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.

This document is a 510(k) summary for the VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0, which are spinal implant devices. It describes the device, its indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. However, it does not contain the information required to answer the specific questions about acceptance criteria and a study that proves the device meets those criteria, especially in the context of an AI/ML device.

The provided text focuses on the regulatory clearance process for a medical device (pedicle screw system), which primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices through material, design, function, and performance testing (e.g., mechanical tests like ASTM F543, F1717, F1798, and biocompatibility).

Here's why the requested information cannot be extracted from this document:

• No mention of AI/ML: The document describes a physical medical device (pedicle screw system) and its mechanical and biocompatibility testing. There is no indication that this device is an AI/ML diagnostic or therapeutic tool with performance metrics like sensitivity, specificity, or accuracy.
• Performance testing is for mechanical equivalence, not diagnostic accuracy: The "Performance Testing Summary" lists standards like ASTM F543 (screw testing) and ASTM F1717 (pedicle screw system testing). These are industry standards for evaluating the mechanical properties and structural integrity of spinal implants. They are not metrics for evaluating the performance of a diagnostic or predictive algorithm.
• "Clinical Data" is mentioned but not detailed: While "Clinical Data" is listed as one of the performance tests, no details are provided about what this data entails, how it was collected, what endpoints were measured, or if it relates to a study proving performance against acceptance criteria for an AI/ML system. In the context of a pedicle screw system, clinical data would typically refer to observational studies or clinical trials assessing patient outcomes, fusion rates, complication rates, etc., which are different from a study proving algorithm performance.
• No acceptance criteria for AI/ML performance: Given the nature of the device, there are no acceptance criteria defined for metrics such as sensitivity, specificity, AUC, or accuracy, which would be relevant for an AI/ML device's performance.

Therefore, since the device described is a physical medical implant and not an AI/ML-driven diagnostic/therapeutic tool, the questions about acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, and standalone performance for an AI/ML device are not applicable to this document.

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