(64 days)
The VERTE-STACK™ Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-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, the DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, the GDLH® Spinal System and/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 POLYETHERETHERKETONE (PEEK 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 corpoctomy. 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.
This 510(k) summary for the VERTE-STACK™ Spinal System (K040536) does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.
Instead, this document is a regulatory submission for a medical device that demonstrates substantial equivalence to a previously cleared device. Substantial equivalence is the primary pathway for medical device approval in the U.S. when a new device is similar enough to an existing legally marketed device (predicate device).
Here's why the requested information is absent and what this document does provide:
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Acceptance Criteria and Reported Device Performance: This document does not include performance metrics (like sensitivity, specificity, accuracy) or acceptance criteria for such metrics because it's not a clinical trial report or a study evaluating a diagnostic or predictive algorithm. The "performance" being assessed here is the device's functional and safety characteristics compared to its predicate.
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Sample Size for Test Set and Data Provenance: Not applicable. There is no "test set" in the sense of a dataset for evaluating an algorithm's performance. The "testing" involved would typically be mechanical, biocompatibility, and sterilization testing to ensure the device itself meets established standards and is equivalent to the predicate. Such details are usually summarized but not presented with raw data in the 510(k) summary itself.
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Number of Experts for Ground Truth and Qualifications: Not applicable. Ground truth, in the context of diagnostic or predictive algorithms, refers to the true medical condition or outcome. This device is an implantable spinal system, not a diagnostic tool requiring expert interpretation of images or data to establish ground truth.
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Adjudication Method: Not applicable for the same reasons as above.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is relevant for evaluating human reader performance with and without AI assistance, which is not the purpose of this device.
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Standalone Performance Study: Not applicable. This type of study is for evaluating an algorithm's performance independent of human input. The VERTE-STACK™ is a physical medical implant.
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Type of Ground Truth Used: Not applicable.
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Sample Size for Training Set: Not applicable. There is no algorithm being trained.
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How Ground Truth for Training Set was Established: Not applicable.
What the document does indicate regarding "equivalence" and "purpose":
- Substantial Equivalence (Section V): The core of this submission is to demonstrate that the VERTE-STACK™ Spinal System is substantially equivalent to a previously cleared device, VERTE-STACK™ Spinal System K030601 (cleared on March 25, 2003). This means the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
- Product Description (Section III): The device is a "stackable spacer" for vertebral body replacement, made from PEEK OPTIMA LT or titanium alloy, and used with supplemental fixation. The purpose of this specific submission (K040536) is "to include a modified version of previously cleared VERTE-STACK™ Spinal System BOOMERANG™ PEEK components." This implies that the modifications were minor enough not to require a completely new evaluation, but still necessitated demonstrating equivalence.
- Indications for Use (Section IV and Enclosure): The device is intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture), always with supplemental fixation and bone graft.
- Regulatory Conclusion: The FDA's letter (K040536) confirms that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed under general controls.
In summary, this 510(k) pertains to a physical medical implant device and not a diagnostic or AI algorithm. Therefore, the requested information regarding acceptance criteria and performance studies in the context of AI or diagnostic accuracy is not present in this type of regulatory submission. The "study" here is the comparison to a predicate device, demonstrating equivalent safety and effectiveness through design, materials, and intended use.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.