(26 days)
The VERTE-STACKTM 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-STACK™ 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. The purpose of this submission is to offer a gamma-sterilized version of the product.
The provided text describes the 510(k) summary for the VERTE-STACK™ Spinal System. However, it does not contain information regarding detailed acceptance criteria, a specific study proving device performance against those criteria, or any of the detailed metrics requested in your prompt (such as sample sizes, ground truth establishment, expert qualifications, or MRMC studies).
Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared predicate device.
Here's how the requested information relates to the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in the document. The basis for clearance is "substantial equivalence" to a predicate device, not specific performance metrics against defined acceptance criteria.
- Reported Device Performance: Not reported in the document. The document states that "Documentation was provided which demonstrated the VERTE-STACK™ Spinal System to be substantially equivalent to the previously cleared VERTE-STACK™ Spinal System (K021791, SE 08/26/02)." This means the device is considered as safe and effective as the predicate, but specific performance data is not included in this summary.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided in the document. No specific "test set" or data provenance details are mentioned because the clearance is based on substantial equivalence to a predicate, not a new clinical 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)
- This information is not provided. There wasn't a "test set" in the context of developing and validating a new AI algorithm where experts would establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided. No adjudication method is mentioned as there's no test set for performance evaluation in the context of this 510(k) summary.
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
- This information is not provided. An MRMC study is not mentioned. This device is a physical implant (spinal system), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This information is not provided. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- This information is not applicable and therefore not provided. The clearance is based on substantial equivalence, not a direct validation against a "ground truth" for a diagnostic or predictive algorithm.
8. The sample size for the training set
- This information is not applicable and therefore not provided. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- This information is not applicable and therefore not provided, as this is not an AI algorithm.
Summary:
The provided 510(k) summary for the VERTE-STACK™ Spinal System describes a physical medical device that achieved FDA clearance by demonstrating substantial equivalence to a previously cleared predicate device (K021791). This type of submission does not typically include detailed performance studies with acceptance criteria, sample sizes, expert ground truth establishment, or AI-specific validation metrics as requested in your prompt. The focus is on showing that the new device is as safe and effective as one already on the market, often through comparison of materials, design, and indications for use.
§ 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.