(50 days)
The VERTE-STACKTM 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, Titanium DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, Titanium TSRH® Spinal System, Titanium CD HORIZON® Spinal System, the Titanium 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 PEEK 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) as described by ASTM F2026. The tantalum marker used for this product is made to the voluntary standard of ASTM F-560.
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 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.
The purpose of this submission is to add modified components to the VERTE-STACK™ Spinal System.
The provided document is a 510(k) summary for the VERTE-STACK™ Spinal System. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and performance study results as if for a novel device. Therefore, much of the requested information (e.g., specific performance metrics, sample sizes for test/training sets, expert qualifications) is not available in this type of submission.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | The VERTE-STACK™ Spinal System was found to be substantially equivalent to the previously cleared VERTE-STACK™ Spinal System (K023570 and K021791). |
| Intended Use | The device is intended for vertebral body replacement in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (fracture). |
| Material Composition | Fabricated from POLYETHERETHERKETONE (PEEK OPTIMA LT) as described by ASTM F2026. The tantalum marker is made to ASTM F-560. |
| Design | Stackable PEEK spacer, available in various sizes and heights to suit individual patient pathology. Can be used individually or stacked. |
| Compatibility with Supplemental Fixation | Must be used with additional anterior and/or posterior spinal instrumentation from specific Medtronic Sofamor Danek systems (e.g., ZPLATE II, DYNALOK™ CLASSIC, VANTAGE™, TSRH®, CD HORIZON®, GDLH®). |
| Use with Bone Graft | Intended to be used with bone graft. |
2. Sample size used for the test set and the data provenance
- Not applicable/Not provided. This 510(k) summary primarily addresses substantial equivalence based on design, materials, and indications for use compared to predicate devices, rather than clinical performance data from a specific test set. There is no mention of a test set being used to evaluate performance against specific acceptance criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. The concept of "ground truth" established by experts for a test set is not relevant for this type of 510(k) submission, which focuses on device design and equivalence.
4. Adjudication method for the test set
- Not applicable/Not provided. No test set or adjudication method is described in this submission.
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
- Not applicable/Not provided. This device is a physical spinal implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not provided. The "ground truth" in this context would implicitly refer to the established safety and effectiveness of the predicate devices based on their prior clearances and clinical experience. The submission relies on the concept of "substantial equivalence" to these known, safe, and effective devices.
8. The sample size for the training set
- Not applicable/Not provided. This is not a machine learning device, so the concept of a "training set" is not relevant.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As above, no training set is relevant.
§ 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.