(87 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, Titanium DYNALOK™ CLASSIC Spinal System, Laurain DeWald 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 F-1579. The Tantalum marker used for this product is made to the voluntary standard of ASTM F-560. The VERTE-SPAN™ components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The VERTE-STACK™ Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability
This is a 510(k) summary for a medical device (VERTE-STACK™ Spinal System), not a study analyzing AI/algorithm performance. Therefore, most of the requested information regarding acceptance criteria, study design, and AI performance metrics is not applicable to this document.
The document describes a spinal implant and its substantial equivalence to previously cleared devices. It does not contain any information about an algorithm, AI, or a study to prove device performance in the context of diagnostic or treatment algorithms.
However, I can extract information related to the device itself:
1. Table of "Acceptance Criteria" and Reported Device Performance:
The document doesn't present "acceptance criteria" in the typical sense of a pre-defined performance metric for an AI or diagnostic algorithm. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The "performance" described is in terms of the device's design, materials, and intended use matching those of already approved devices.
| Acceptance Criterion (Implied via Substantial Equivalence) | Reported Device Performance (VERTE-STACK™) |
|---|---|
| Material Composition | Fabricated from PEEK OPTIMA LT (ASTM F-1579) and Tantalum marker (ASTM F-560) |
| Intended Use | Vertebral body replacement in thoracolumbar spine (T1-L5) due to tumor or trauma (fracture) |
| Use with Supplemental Fixation | Must be used with additional anterior and/or posterior spinal instrumentation |
| Compatibility with Specific Systems | To be used with listed Medtronic Sofamor Danek fixation systems or their successors, and bone graft |
| Design/Configuration | Stackable PEEK spacer, rigidly lockable into various configurations |
| Clinical Efficacy/Safety | Implied by substantial equivalence to predicate devices (VERTE-SPAN™ Spinal System, DePuy AcroMed Stackable Cage System, OEC/Rezaian Spinal Fixator, Osteotech Vertebral Body Replacement device, PYRAMESH®-C Implant System) which have established safety and efficacy. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This document is about a physical medical device, not an AI or algorithm. There is no "test set" in the context of data for an algorithm. The evidence for substantial equivalence is based on comparisons of design, materials, and indications for use against predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. See point 2.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. See point 2.
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. There is no AI or algorithm involved in this submission.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Not Applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable as a "ground truth" for an algorithm. The "truth" in this context is the regulatory acceptance of predicate devices based on their established material properties, design, and clinical performance, all of which would have been supported by previous submissions (e.g., mechanical testing, potentially animal or limited human clinical data for the original predicates, and extensive literature on spinal fusion principles).
8. The sample size for the training set:
- Not Applicable. There is no algorithm training set.
9. How the ground truth for the training set was established:
- Not Applicable. There is no algorithm training set.
In summary: This document is a regulatory submission for a physical medical implant (VERTE-STACK™ Spinal System) demonstrating substantial equivalence to pre-existing, legally marketed devices. It does not involve any AI, algorithms, or studies of their performance.
§ 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.