(43 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 and screws made of titanium alloy (Ti-6Al-4V per ASTM F1472 and Ti-6Al-4V ELI per F136) and CP titanium per ASTM F67. The Pyrenees Cervical Plates are offered in both constrained and translational designs and the screws are fixed or variable. The subject 510(k) adds screws with a cobalt chrome component (per ASTM F1537) to the system. The Pyrenees system components are provided non-sterile.
Function: The system functions as a spinal fixation device to provide support and stabilization of the cervical vertebrae.
The provided document is a 510(k) premarket notification for a medical device called the "Pyrenees Cervical Plate System". It primarily focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information about acceptance criteria and study details cannot be found in this document.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the document in the format of acceptance criteria. The document states that the device was tested according to ASTM F1717 for static compression, static torsion, and dynamic compression. The conclusion is that the modifications to the screws did not represent a new worst-case, and there were no significant differences compared to predicate devices which would adversely affect the use of the product. No specific numerical acceptance criteria or performance metrics are listed.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Not specified | Not specified beyond compliance with ASTM F1717 and no new worst-case for screw modifications. |
2. Sample size used for the test set and the data provenance
The document describes non-clinical performance evaluation, which refers to mechanical testing of the implants rather than a clinical study with a patient test set. Therefore, information about a "test set" in the context of patient data (e.g., country of origin, retrospective/prospective) is not applicable or present.
- Sample size for non-clinical testing: Not explicitly stated, beyond stating that "the predicate and subject Pyrenees implants were tested."
- Data provenance: Not applicable as this refers to mechanical testing, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document describes mechanical testing of a medical device, not a study involving human experts to establish ground truth for a test set.
4. Adjudication method for the test set
This information is not applicable as the document describes mechanical testing of a medical device, not a study involving human readers or a test set requiring 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
No such study is mentioned or implied, as the document details the mechanical properties of a spinal plate system, not an AI-assisted diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not relevant to this type of medical device (spinal plate system). The document describes mechanical testing of the physical device components.
7. The type of ground truth used
The "ground truth" in this context would be the physical properties and performance characteristics of the device under specific mechanical loads, as defined by engineering standards (ASTM F1717).
- Type of "ground truth": Mechanical test results and engineering analysis, based on ASTM F1717.
8. The sample size for the training set
This information is not applicable as the document describes mechanical testing of a medical device, not a machine learning model that would require a training set.
9. How the ground truth for the training set was established
This information is 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.