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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 Titanium DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, the Titanium TSRH® Spinal System, the Titanium CD HORIZON® Spinal System or the Titanium GDLH® Spinal System. 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 titanium alloy. Alternatively the device may be manufactured from POLYETHERETHERKETONE (PEEK OPTIMA LT) and includes a tantalum marker.

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 anatomy.

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 offer a titanium version of the previously cleared VERTE-STACK™ Spinal System components.

The provided text is a 510(k) summary for the VERTE-STACK™ Spinal System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than for proving the acceptance criteria of a novel device through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not applicable or not present in this document.

Here's an analysis of the available information:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. 510(k) summaries for spinal implants typically focus on demonstrating mechanical and material equivalence to existing devices, along with similar indications for use. They do not usually include acceptance criteria and performance data in the way a clinical trial for a diagnostic device or a new therapeutic device might.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not provided as there is no specific "test set" or clinical study described in terms of patient data. The submission relies on establishing substantial equivalence to previously cleared devices (K041556 and K040422).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. As there's no clinical test set for diagnostic performance, ground truth establishment by experts is not applicable here.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided as there is no clinical test set with an adjudication process described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable and not provided. This device is a spinal implant, not an AI-powered diagnostic or assistive tool, so an MRMC study is irrelevant to its approval.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not applicable and not provided. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not applicable and not provided. For a spinal implant 510(k), "ground truth" in the clinical sense of diagnostic accuracy is not the primary focus. The "truth" in this context revolves around demonstrating the material properties, mechanical performance, and biomechanical equivalence to predicate devices, often through bench testing and engineering analysis rather than human ground truth.

8. The sample size for the training set:

This information is not provided. The concept of a "training set" is typically associated with machine learning or AI algorithm development, which is not relevant to this medical device submission.

9. How the ground truth for the training set was established:

This information is not applicable and not provided for the same reasons as in point 8.

Summary of what the document does indicate:

The submission focuses on demonstrating substantial equivalence of a titanium version of the VERTE-STACK™ Spinal System to previously cleared VERTE-STACK™ Spinal System components (K041556 and K040422). This means that the device is considered safe and effective because it is similar to devices already on the market. The basis for approval is that the new titanium version shares similar design, materials (with the exception of the specific titanium versus PEEK), intended use, and performance characteristics with the predicate devices. The document highlights:

• Product Description: A stackable spacer for vertebral body replacement in the anterior thoracic and lumbar spine, made from titanium alloy (previously PEEK OPTIMA LT was also an option).
• Intended Use: Thoracolumbar spine (T1-L5) to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma, always used with supplemental fixation and bone graft.
• Substantial Equivalence: Documentation was provided demonstrating equivalence to K041556 and K040422. This is the "study" alluded to, but it's a comparison to predicates, not a clinical trial with acceptance criteria for device performance in patients.

In essence, this 510(k) summary is not a report of a clinical study designed to meet specific performance acceptance criteria for a novel device, but rather a regulatory filing asserting similarity to existing approved devices.

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