(46 days)
The Synex™ II implant is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Synex II device is intended to be used with Synthes supplemental internal fixation systems, e.g., TSLP, Pangea and USS.
The Synex II device is designed to provide anterior spinal column support, even in the absence of fusion, for a prolonged period.
The Synex II Spacer is a height expanding vertebral body replacement device consisting of a hollow central body and two endplates. The cylindrical body is comprised of two telescoping end pieces and a locking ring. The walls of the hollow cylindrical body have a plurality of holes intended for the placement of grafting materials to help achieve a solid fusion. Endplates are available in three footprint sizes. Each endplate is angled, has a plurality of holes and is designed with pyramidal teeth and small spikes to grip the adjacent vertebra.
The SYNEX™ II Spacer is a spinal intervertebral body fixation device. The manufacturer conducted mechanical testing to demonstrate its performance.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document states that "Mechanical testing in accordance with the 'Guidance for Spinal System 510(k)s', issued May 3, 2004, was presented." However, the specific acceptance criteria (e.g., minimum load to failure, fatigue life) from this guidance document and the detailed results of the SYNEX™ II Spacer's performance against these criteria are not explicitly provided in the given text.
Therefore, the table below indicates that the specific criteria and results are not reported within this summary. To fully populate this table, one would need access to the detailed mechanical testing report submitted to the FDA, which is beyond the scope of the provided excerpts.
| Acceptance Criteria (from "Guidance for Spinal System 510(k)s") | Reported Device Performance |
|---|---|
| Not explicitly reported in this 510(k) summary | Not explicitly reported in this 510(k) summary |
| (e.g., Axial Compression Strength) | (e.g., Device met or exceeded [X] N) |
| (e.g., Axial Compression Fatigue) | (e.g., Device survived [Y] cycles at [Z] N) |
| (etc.) | (etc.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text. Mechanical testing typically involves a certain number of samples for each test type (e.g., n=3 or n=6 per condition), but the exact number is not reported here.
- Data Provenance: The testing was conducted by the manufacturer, Synthes Spine Co. L.P. The location of the testing facility is not explicitly stated, but it would have been an in-house lab or a contracted testing facility. The data is based on scientific/engineering testing of physical samples, not human clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This question is not applicable as the study involved mechanical testing of the device, not a human reader study or clinical trial requiring expert ground truth establishment for a diagnostic outcome. The "ground truth" for mechanical testing is derived from established engineering principles and measurements against validated testing standards.
4. Adjudication Method for the Test Set:
This question is not applicable for mechanical testing. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly for radiology reads, to resolve discrepancies among expert readers.
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:
No, an MRMC comparative effectiveness study was not done. This device is an implantable medical device undergoing mechanical performance testing, not an AI-enabled diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone algorithm performance evaluation was not done. This device is a physical implant, not a software algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this study was established through adherence to standardized mechanical testing protocols and specifications outlined in the "Guidance for Spinal System 510(k)s" issued May 3, 2004. This ground truth is based on quantitative measurements (e.g., force, displacement, cycles) and material properties that simulate the physiological environment.
8. The Sample Size for the Training Set:
This question is not applicable. Mechanical testing does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reason as #8.
§ 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.