(25 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, 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 consists of hemi-cylindrical center cages of various lengths and diameters, as well as hemi-cylindrical add on cages of various lengths, diameters and angulation. The assembled VERTE-STACK® device consists of three components (one hollow center cage, and two hollow add-on cages). The VERTE-STACK® components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
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 implant components are made of medical grade PEEK-OPTIMA LT1 along with a marker made from either Tantalum or titanium. Alternatively, VERTE-STACK® Spinal System may be manufactured from titanium alloy.
The VERTE-STACK® Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. VERTE-STACK® constructs manufactured from 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 was to modify the wording of the VERTE-STACK® Spinal System package insert by removing certain contraindications and by including a NOTA BENE for potential factors to consider with regards to when not to use this device. The rewording of the document makes it more consistent with that of the package insert for the CD HORIZON® Spinal System, which may be used as the supplemental fixation device for the VERTE-STACK® device.
This is a 510(k) summary for a spinal implant device, the VERTE-STACK® Spinal System, rather than a diagnostic AI device. Therefore, the information requested regarding acceptance criteria and studies proving device performance for AI-based systems (e.g., sample size for test set, AI vs. human reader improvement, ground truth establishment) is not applicable in this context.
This summary details a modification to the package insert of an existing device and establishes its substantial equivalence to previously cleared predicate devices. It does not contain information about performance studies in the way an AI/ML device submission would.
Here's an attempt to answer the applicable parts based on the provided text, while noting the limitations:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" or "reported device performance" in the typical sense of a diagnostic or AI device. Instead, the focus is on substantial equivalence to predicate devices. The "performance" assessment is implied by demonstrating that:
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Demonstrated) |
|---|---|
| Same Intended Use: Device must have the same intended use as legally marketed predicate devices. | The VERTE-STACK® Spinal System has the same indications for use as previously cleared VERTE-STACK® components (K061938) and the CD HORIZON® Spinal System (K061304). |
| Similar Technological Characteristics: Device must have similar technological characteristics as legally marketed predicate devices. | The product description notes that the components are made of medical grade PEEK-OPTIMA LT1 with Tantalum or titanium markers, or titanium alloy, which aligns with materials typically used in predicate spinal systems. The design for various lengths, diameters, and angulations for individual patient pathology suggests consistency with established spinal implant design principles. |
| Safety and Effectiveness: Differences in technological characteristics do not raise new questions of safety and effectiveness, or demonstrate that the device is as safe and effective as the legally marketed predicate device. | The submission primarily focused on modifying the wording of the package insert, specifically removing certain contraindications and including a "NOTA BENE" for potential factors. The document states this re-wording makes it "more consistent with that of the package insert for the CD HORIZON® Spinal System." This implies that the device's safety and effectiveness were already established with the predicate device and that the label change does not alter this, but rather clarifies usage. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for a spinal implant, not an AI or diagnostic device that typically undergoes performance testing with test sets of data. The submission relies on demonstrating substantial equivalence to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth establishment with experts is relevant for AI or diagnostic devices, not for a spinal implant demonstrating substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for evaluating expert consensus in diagnostic studies, which is not the type of study presented here.
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. MRMC studies are for evaluating diagnostic performance, often in the context of AI assistance. This document describes a surgical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of a diagnostic or AI device's ground truth. However, in the context of a medical device submission striving for substantial equivalence, the "ground truth" is implicitly established by the safety and effectiveness of the predicate devices and the regulatory standards for such devices.
8. The sample size for the training set
Not applicable, as this is not an AI device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI device.
In summary: The provided document is a 510(k) summary for a physical medical device (spinal implant) and its label modification, not an AI/ML or diagnostic device. Therefore, the questions related to AI acceptance criteria, test sets, ground truth establishment, and multi-reader studies are not addressed by the document. The "study" described is the submission of documentation to demonstrate substantial equivalence to predicate devices.
§ 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.