(351 days)
The Genesys Spine Anterior Cervical Plate II System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, or scoliosis), pseudoarthrosis, failed previous fusion, and/or spinal stenosis.
The Genesys Spine Anterior Cervical Plate II System will be offered in various device configurations based on surgical approach and patient anatomy, and will consist of a Genesys Spine cervical plate and screws that are inserted into the anterior surface of adjacent cervical vertebrae.
The Genesys Spine Anterior Cervical Plate II System is comprised of multiple sizes of plates and screws that are inserted into the anterior surface of adjacent cervical vertebrae. The device is applied after discectomy and insertion of autograft or allograft in the interbody space, and acts to stabilize the spine during fusion.
The plate components are manufactured from medical grade Ti-6Al-4V ELI titanium alloy per ASTM F-136. Additionally, cervical plates contain a securement tab component comprised of Nickel-Titanium (Nitinol) per ASTM F2063-00 to ensure that the screw is locked in place. The bone screws are manufactured from medical grade Ti-6Al-4V ELI titanium alloy per ASTM F-136.
This document describes a medical device, the Genesys Spine Anterior Cervical Plate II System, and its substantial equivalence to previously cleared devices, rather than a study proving the device meets specific acceptance criteria in a clinical or diagnostic context.
Therefore, many of the requested categories related to diagnostic device performance, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details, are not applicable to this 510(k) summary for a spinal implant.
However, I can extract the information pertinent to the performance data presented, which focuses on mechanical testing.
Here's the relevant information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Predetermined Pass-Fail Criterion) | Reported Device Performance |
|---|---|
| The mechanical test results for the Genesys Spine Anterior Cervical Plate II System be equivalent to (or greater than) previously cleared anterior cervical plate systems. | Static axial compression, static torsion, and dynamic axial compression testing were performed in accordance with ASTM F1717. Corrosion testing was performed in accordance with ASTM F2129. The overall technological characteristics and mechanical performance data lead to the conclusion that the Genesys Spine Anterior Cervical Plate II System is substantially equivalent to the Genesys Spine Anterior Cervical Plate System (K111132), the Synthes Anterior CSLP System (K000536 / K945700), and the Pioneer Aspect Anterior Cervical Plate System (K130427). The document implies that the device met this criterion by demonstrating substantial equivalence based on these tests, meaning its mechanical performance was found to be comparable to or better than the predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document discusses mechanical testing of the device itself, not a clinical study on human subjects. Therefore, the concept of "sample size for the test set" in a clinical context or "data provenance" (country of origin, retrospective/prospective) is not applicable. The "samples" would refer to the physical devices or components tested in a laboratory setting. No specific number of devices tested is provided in this summary, but it would have been sufficient to meet the requirements of the ASTM standards.
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 section is not applicable as the evaluation is based on mechanical performance standards (ASTM) and comparison to predicate devices, not on expert clinical ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable as the evaluation is based on mechanical performance standards and comparison to predicate devices, not on expert clinical 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
This section is not applicable. This document describes a spinal implant, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable. This document describes a spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by engineering standards and comparison to legally marketed predicate devices. Specifically, the mechanical performance was assessed against ASTM F1717 and ASTM F2129, and the results were found to be equivalent to or superior to the predicate devices.
8. The sample size for the training set
This section is not applicable. This document describes a spinal implant, not a machine learning model.
9. How the ground truth for the training set was established
This section is not applicable. This document describes a spinal implant, not a machine learning model.
§ 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.