(106 days)
The Axis Anterior Cervical Plate 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 from levels C2 through T1 of the cervical spine. The system is indicated for use in the stabilization of the anterior cervical spine during the development of cervical spinal fusion in patients. The indications include spinal stenosis, degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,), tumors, deformity (defined by kyphosis, lordosis, or scoliosis), and/or pseudoarthrosis (defined as failed previous fusion).
Axis Anterior Cervical Plate System is a plate and screw system composed of medical grade titanium Ti-Alloy (Ti-6Al-4V ELI) components. The titanium plates are available in a variety of lengths, addressing multiple levels of fixation. The plates contain an integrated locking mechanism which interfaces with fixed and variable angled screws, of various diameters and lengths, to accommodate anatomical variation when securing the plate-screw construct to the anterior cervical vertebral bodies. The system is intended to provide mechanical support to the implanted level(s) until fusion is achieved. To accommodate normal cervical spine lordosis, and at the same time eliminate the need for additional plate contouring, Axis Anterior Cervical Plates come with a prelordosed curve. Various instruments are available to facilitate the implantation of the device.
This document is a 510(k) summary for the Axis Anterior Cervical Plate System. It describes the device, its indications for use, and a summary of performance testing to demonstrate substantial equivalence to predicate devices. The information provided is not about an AI/ML powered device, but a physical medical implant. Therefore, the requested information about acceptance criteria for an AI device, sample sizes for test/training sets, expert involvement, and ground truth establishment, which are typical for AI/ML validation studies, are not applicable here.
However, I can extract the information relevant to the performance assessment of this physical device as presented in the document itself.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this physical medical device are related to its mechanical performance, demonstrating equivalence to a predicate device based on specific ASTM standards.
| Acceptance Criteria (based on ASTM Standards) | Reported Device Performance |
|---|---|
| Equivalence to predicate device per ASTM F1717-15 (Static Compressive Bending, Static Torsion, Fatigue Compression Testing) | The subject plate performed equivalently to the predicate device (Medtronic Atlantis Vision Anterior Cervical Plate System) in static compressive bending, static torsion, and fatigue compression testing as per ASTM F1717-15. |
| Sufficient screw performance per ASTM F543-13e1 | The subject screws performed sufficiently to pass the evaluation criteria set forth in the protocol that was derived from the applicable ASTM standard (ASTM F543-13e1). (No specific quantitative values are provided in this summary, but it states the criteria were met.) |
| Geometric comparison to mechanical predicate | An engineering comparison (Appendix A, not provided in this excerpt) was performed, showing a geometric comparison between the subject AXIS device and a mechanical predicate (Exactech Ambassador). The conclusion implies this comparison supported substantial equivalence. |
Study Proving Device Meets Acceptance Criteria:
A performance assessment was conducted through mechanical testing.
- Study Type: Mechanical performance testing.
- Standards Used: ASTM F1717-15 and ASTM F543-13e1.
- Objective: To demonstrate that the Axis Anterior Cervical Plate System is equivalent to a predicate device with respect to the testing recommended in these ASTM standards.
The following sections are not applicable as this is not an AI/ML device:
- 2. Sample sized used for the test set and the data provenance: Not applicable. This refers to physical testing of the device components, not data analysis.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device is established through engineering and material science specifications and testing.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth here is the established mechanical performance standards as outlined in ASTM F1717-15 and ASTM F543-13e1, and the performance of the predicate devices.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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.