(11 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 turnor 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 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 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 include slightly modified components to the previously cleared VERTE-STACK™ Spinal System.
This 510(k) Summary for the VERTE-STACK™ Spinal System describes a medical device submission, not a study evaluating device performance against acceptance criteria in the typical sense of a clinical or analytical study for new AI/diagnostic devices.
Therefore, the requested information elements related to acceptance criteria, device performance, sample sizes, experts, adjudication, MRMC studies, standalone performance, and ground truth establishment are not applicable or available within this document.
This document is a regulatory submission focused on demonstrating substantial equivalence to a previously cleared device, not on proving clinical efficacy or diagnostic accuracy through a new study.
Here's how to interpret the provided information in the context of your request:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document does not describe performance criteria for a study. The acceptance criterion for this submission is "substantial equivalence" to a predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No test set or data provenance is mentioned as this is a device modification for substantial equivalence, not a new performance study.
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. No ground truth establishment by experts is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method is 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
- Not Applicable. This is not an AI/diagnostic device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/diagnostic device, and no standalone performance study was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No ground truth is mentioned.
8. The sample size for the training set
- Not Applicable. No training set is mentioned.
9. How the ground truth for the training set was established
- Not Applicable. No training set or ground truth establishment is mentioned.
Summary of the document's relevance to "acceptance criteria" and "study":
The "acceptance criteria" for this submission were met by demonstrating substantial equivalence to an already cleared device (K041452). This means that the modified components of the VERTE-STACK™ Spinal System were deemed to have the same intended use, technological characteristics, and safety/effectiveness profile as the previously cleared version. The "study" described is essentially the process of submitting documentation to the FDA to prove this substantial equivalence, rather than a clinical trial or performance evaluation.
§ 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.