(30 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, 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 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 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 VERTF-STACK™ constructs may not be used with stainless steel supplemental fixation devices.
The purpose of this submission is to include a titanium version of previously cleared VERTE-STACKTM Spinal System components.
The provided text describes a 510(k) submission for the VERTE-STACK™ Spinal System, which is a vertebral body replacement device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive new clinical studies with acceptance criteria in the same way a PMA (Pre-Market Approval) study would.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes for test/training sets, expert involvement, and ground truth establishment are not typically part of a 510(k) submission document like this. The primary "study" in a 510(k) is a comparison to a predicate device.
Here's an analysis based on the provided document:
1. Table of acceptance criteria and reported device performance
The document does not provide specific quantitative acceptance criteria or detailed performance results in the format of a clinical study for the VERTE-STACK™ Spinal System. For a 510(k) submission, the "acceptance criteria" revolve around demonstrating substantial equivalence to a predicate device in terms of indications for use, technological characteristics, and safety and effectiveness.
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance (Summary from text) |
|---|---|
| Indications for Use Equivalence | Met: The Indications For Use for the VERTE-STACK™ Spinal System are stated as being for vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor or trauma, to be used with supplemental fixation and bone graft. These were found substantially equivalent to the predicate devices. |
| Technological Characteristics Equivalence | Met: The submission is specifically to include a titanium version of the previously cleared VERTE-STACK™ components. The original PEEK version uses a tantalum marker. The core function and design principles are considered equivalent to the predicate. |
| Safety and Effectiveness Equivalence | Met: Demonstrated by showing substantial equivalence to previously cleared devices (VERTE-STACK™ K031780 and VERTE-SPAN™ K010930). This implies that the device is considered as safe and effective as the predicate. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of a 510(k) for a spinal implant. There is no "test set" in the sense of a patient cohort or imaging dataset used to evaluate an algorithm. The evaluation is primarily based on comparison to predicate devices and engineering/material data (which are not detailed in this summary).
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth establishment with experts is typical for diagnostic algorithms, not for spinal implants in a 510(k) submission.
4. Adjudication method for the test set
- Not applicable. There was no test set requiring expert adjudication.
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. This is a medical device (spinal implant), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (spinal implant), not an algorithm.
7. The type of ground truth used
- The "ground truth" for a 510(k) for a medical device like this is the established safety and effectiveness of its predicate devices, backed by clinical use and regulatory clearance. The basis of comparison focuses on material properties, design specifications, and indications for use.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/machine learning model.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.