(102 days)
The VERTEBRON Interbody Fusion System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease ("DDD") at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
The VERTEBRON Interbody Fusion System is implanted via an anterior or posterior approach and is to be combined with cleared supplemental fixation systems, such as the VERTEBRON PSS Pedicle Screw System.
The VERTEBRON Interbody Fusion System consists of various heights, angles and configurations (i.e., square, rectangular D-shaped, etc.). The device is use singly or in pairs to better approximate the anatomical variations observed in different vertebral levels and/or patient anatomy.
The VERTEBRON Interbody Fusion System is comprised of a variety of components fabricated and manufactured from Polyetheretherketone (PEEK) as described by ASTM 2026. This material is utilized due to its radiolucent properties, which aid the surgeon in determining if fusion in the operative site has occurred.
The VERTEBRON Interbody Fusion System has a hollow chamber to permit packing with autogenous bone graft to facilitate fusion, but is of sufficient strength to provide column support even in the absence of fusion for prolonged periods. The superior and inferior surfaces of the construct have a pattern of teeth to provide increased stability and to help prevent movement of the device. Tantalum wire markers (ASTM F560) are inserted into the components to give surgeons a visual aid in determining the location of the implant, both inter and post-operatively.
The material used is PEEK ASTM F2026-07e1 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications or titanium alloy (TI-6AI-4V) that conforms to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) and ASTM F560 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications.
The VERTEBRON Interbody Fusion System is an intervertebral body fusion device. The acceptance criteria and the study performed for this device are described below, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Study Method |
|---|---|---|
| Conformity to ASTM F2077-03 for Interbody Fusion Devices (Mechanical Static and Dynamic Testing) | Meets mechanical performance requirements for interbody fusion devices | ASTM F2077-03: "Standard Test Methods for Intervertebral Body Fusion Devices" |
| Conformity to ASTM F2267 for Measuring Load Induced Subsidence | Meets load-induced subsidence resistance requirements | ASTM F2267: "Standard Test Methods for Measuring Load Induced Subsidence of an Interbody Fusion Device Under Static Axial Compression" |
| Material Specification: PEEK ASTM F2026-07e1 | Device comprised of PEEK conforming to ASTM F2026-07e1 | Material testing and documentation |
| Material Specification: Titanium Alloy (TI-6AI-4V) ASTM F136 | Not explicitly stated as used in this device's description, but acceptable if used. PEEK described as primary material due to radiolucent properties. | Material testing and documentation (if applicable) |
| Material Specification: Unalloyed Tantalum ASTM F560 (for markers) | Tantalum wire markers conforming to ASTM F560 are inserted. | Material testing and documentation |
| Implantation Approach Compatibility | Verified for use via anterior or posterior approach | Not a performance criteria directly, but an intended use parameter. |
| Compatibility with Supplemental Fixation Systems | Combined with cleared supplemental fixation systems (e.g., VERTEBRON PSS Pedicle Screw System) | Not a performance criteria for the device itself, but a condition of use. |
2. Sample Size for the Test Set and Data Provenance
The provided 510(k) summary does not contain information about a test set with human subject data for efficacy or safety comparisons. The studies mentioned are primarily bench testing for mechanical properties.
- Sample Size: Not applicable for human data. For mechanical testing, the sample size would be determined by the ASTM standards (e.g., number of devices tested). This specific detail is not provided.
- Data Provenance: Not applicable for human data. For mechanical testing, the data would be generated from laboratory tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The studies referenced are mechanical bench tests against established ASTM standards, not clinical studies requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This 510(k) pertains to a medical implant (interbody fusion system), not an AI or imaging diagnostic device where MRMC studies are typically performed.
6. Standalone Performance Study
Yes, a standalone study in the context of mechanical performance was conducted. The device's mechanical properties were evaluated in a standalone manner (i.e., the device itself, without human interaction influencing performance in the test) against the specified ASTM standards. This is a "standalone" evaluation of the device's physical and mechanical characteristics.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation of this device was based on widely accepted engineering and material standards (ASTM F2077-03 and ASTM F2267 for mechanical properties; ASTM F2026-07e1, ASTM F136, and ASTM F560 for material specifications). The device was evaluated against these predefined, objective standards for mechanical strength and material composition.
8. Sample Size for the Training Set
Not applicable. This device is an implanted medical device, not an AI or machine learning algorithm that requires a training set. The performance evaluation relies on engineering principles and bench testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI/ML component, there is no training set or ground truth required to be established for one.
§ 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.