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The VERTE-STACK® Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-STACK® Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK® device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the VERTE-STACK® device is intended to be used with bone graft.

The VERTE-STACK® device is a stackable spacer, which inserts between vertebral bodies in the anterior thoracic and lumbar spine. The device is intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine. The construct is not intended to be employed as a stand-alone device. The VERTE-STACK® device is fabricated and manufactured from POLYETHERETHERKETCNE (PEFK OPTIMA LT) along with a tantalum marker. Alternatively the device may be manufactured from titanium alloy.

The design of the VERTE-STACK® device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient pathology.

The VERTE-STACK® device may be used individually, or two or more may be stacked together in order to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

The VERTE-STACK® Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. VERTE-STACK® constructs manufactured with PEEK may be used with stainless steel or titanium supplemental fixation devices. Titanium VERTE-STACK® constructs may not be used with stainless steel supplemental fixation devices.

The purpose of this submission is to include additional components (VERTE-STACK® CRESCENT™) to the previously cleared VERTE-STACK® Spinal System.

This looks like a 510(k) summary for a medical device (VERTE-STACK® Spinal System), which is a premarket notification to the FDA. These documents primarily focus on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study with acceptance criteria for a new AI/algorithm-based diagnostic or clinical decision support system.

Therefore, the provided document DOES NOT contain the kind of information requested regarding acceptance criteria and a study proving device performance for an AI/algorithm-based device.

The document describes a physical spinal implant and its components. The "proof" for this type of device typically comes from:

• Substantial Equivalence (SE): Demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is the core of a 510(k) submission. The document explicitly states this in section V.
• Mechanical Testing: Bench testing and material characterization to ensure the device meets engineering specifications for strength, durability, biocompatibility, etc. This is usually summarized or referenced, but specific acceptance criteria and detailed study results are generally not in the 510(k) summary itself.

In summary, because this is a 510(k) submission for a physical spinal implant, it does not include the information you're asking for about acceptance criteria and a study proving performance in the context of an AI/algorithm-driven device.

If this were a document for an AI-based device, the sections you've outlined would be critical. However, this specific document does not lend itself to those questions.

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