(45 days)
K2M Cervical Plate Systems are indicated for use in anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fractures), spinal stenosis and tumors (primary and metastatic), failed previous fusions (pseudarthrosis) and deformity (defined as scoliosis, kyphosis or lordosis).
The Pyrenees Cervical Plate System consists of plates (1-5 level) and screws (self-tapping and self-starting) made of titanium alloy per ASTM F1472 and CP titanium per ASTM F67. The plates range in length from 18-110mm and the screws from 10-22mm. The Pyrenees Cervical Plates are offered in both constrained and translational designs. The subject 510(k) adds plates to the system. The Pyrenees system components are provided non-sterile.
The provided document describes the K2M Pyrenees Cervical Plate System, a spinal fixation device, and its substantial equivalence to predicate devices. It does not contain information about the acceptance criteria or a specific study that quantitatively proves the device meets those criteria in the context of device performance metrics like sensitivity, specificity, or accuracy, which are typical for studies involving AI or diagnostic devices.
The document focuses on the regulatory clearance for a physical medical device (cervical plate system) based on material, design, function, and mechanical performance rather than a diagnostic algorithm or AI system. Therefore, most of the requested fields are not applicable to the information contained in this document.
Here's a breakdown of the available information and why other fields are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., benchmark for mechanical strength) | Reported Device Performance |
|---|---|
| Static compression performance in accordance with ASTM F1717 | Performed equally to or better than predicate devices |
| Static torsion performance in accordance with ASTM F1717 | Performed equally to or better than predicate devices |
| Dynamic compression performance in accordance with ASTM F1717 | Performed equally to or better than predicate devices |
2. Sample size used for the test set and the data provenance: Not applicable. This is a mechanical device, not a diagnostic or AI system. The testing involved mechanical measurements on plate samples, not patient data.
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 mechanical testing is established by engineering standards and measurement equipment, not expert human assessment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for mechanical testing.
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. No AI or human reader component is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the mechanical performance of the Pyrenees Cervical Plate System was established by adherence to ASTM F1717 standards for static and dynamic mechanical properties.
8. The sample size for the training set: Not applicable. There is no "training set" in the context of mechanical device testing as described. Product development iterations might involve prototypes, but it's not a "training set" as understood in AI/ML.
9. How the ground truth for the training set was established: Not applicable. No training set in the AI/ML sense exists.
Summary of available information from the document:
- Device Type: Pyrenees Cervical Plate System (spinal intervertebral body fixation orthosis).
- Purpose: Anterior screw fixation to the cervical spine (C2-C7).
- Indications for Use: Degenerative disc disease (DDD), spondylolisthesis, trauma (including fractures), spinal stenosis, tumors, failed previous fusions (pseudarthrosis), and deformity.
- Materials: Titanium alloy per ASTM F1472 and CP titanium per ASTM F67.
- Testing Performed: Non-clinical mechanical performance evaluation.
- Standards Used: ASTM F1717 (for static compression, static torsion, and dynamic compression).
- Conclusion of Testing: The plates performed equally to or better than predicate devices in the specified mechanical tests.
- Regulatory Status: Substantially equivalent to legally marketed predicate devices.
§ 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.