(40 days)
The Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) as an adjunct to fusion. These implants have been designed to provide stabilization for the treatment of the following indications: degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, or scoliosis), tumor, pseudarthrosis or failed previous fusion.
The Cervical Plate System is an anterior cervical plating system that consists of plates and selftapping screws. The implants are available in a variety of shapes to accommodate the anatomical condition of patients. The subject device components are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
Here's a breakdown of the acceptance criteria and study information for the Cervical Plate System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Test) | Reported Device Performance |
|---|---|
| Static compression bending per ASTM F1717 | "sufficient for its intended use" |
| Static torsion per ASTM F1717 | "sufficient for its intended use" |
| Dynamic compression bending per ASTM F1717 | "sufficient for its intended use" |
Note: The document states that the mechanical performance data leads to the conclusion that the device is "substantially equivalent" to the predicate device. However, it does not explicitly provide numerical acceptance criteria or specific numerical results for these tests. It only states that the device's strength is "sufficient" and comparable to predicate devices.
2. Sample Size for Test Set and Data Provenance
This information is not provided in the document. The studies mentioned are mechanical performance tests (in vitro), not clinical studies involving human patients or data. Therefore, concepts like country of origin for data or retrospective/prospective studies are not applicable here.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable as the evaluation relies on mechanical testing against ASTM standards, not expert review of clinical data.
4. Adjudication Method for Test Set
This information is not applicable as the evaluation relies on mechanical testing against ASTM standards, not expert review of clinical data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on the mechanical substantial equivalence of a physical medical device (Cervical Plate System) through in vitro testing, not on evaluating the effectiveness of an AI algorithm or human reader performance.
6. Standalone (Algorithm Only) Performance Study
This information is not applicable. The device described is a physical implant (Cervical Plate System), not an algorithm or AI-driven system.
7. Type of Ground Truth Used
The "ground truth" for the device's performance is established by ASTM F1717 standards for static and dynamic mechanical properties of spinal intervertebral body fixation orthoses. The document states "The Cervical Plate System has been tested in the following test modes: - Static compression bending per ASTM F1717 . - Static torsion per ASTM F1717 ● - Dynamic compression bending per ASTM F1717".
8. Sample Size for Training Set
This information is not applicable. There is no mention of a "training set" as this is a mechanical device, not an AI or machine learning system that requires training data.
9. How Ground Truth for Training Set Was Established
This information is not applicable for the same reason as above; there is no training set mentioned or implied for this mechanical device.
§ 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.