(226 days)
The CoreLink TERRACE™ Anterior Cervical Plate System is intended for anterior fixation of the cervical spine. Indications for use include the temporary stabilization of the anterior spine during the evolution of cervical fusions in patients with degenerative disc disease (DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions. The intended levels for treatment range from C2 – T1.
The Terrace™ Anterior Cervical Plate System is indicated for one through five levels of fixation and are provided in multiple sizes to accommodate a variety of patient anatomies. Screws are provided in multiple sizes to accommodate a variety of patient anatomies. Implants are manufactured from Ti-6Al-4V ELI conforming to ASTM F136 and nitinol conforming to ASTM F2063. Implants are provided non-sterile with instructions for sterilization.
The provided document describes the Terrace™ Anterior Cervical Plate System, a medical device, and its submission for FDA clearance (K163104). This document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data, primarily mechanical testing.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Standard) | Reported Device Performance (Summary) |
|---|---|
| Static axial compression bending per ASTM F1717-14 | Results sufficient for intended use; substantially equivalent to predicate devices. |
| Static torsion per ASTM F1717-14 | Results sufficient for intended use; substantially equivalent to predicate devices. |
| Dynamic axial compression bending fatigue per ASTM F1717-14 | Results sufficient for intended use; substantially equivalent to predicate devices. |
| Corrosion testing per ASTM F2129 | Results sufficient for intended use; substantially equivalent to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific sample sizes (e.g., number of devices or constructs tested) for the mechanical tests. It also does not specify the provenance of the data in terms of country of origin or whether it was retrospective or prospective, as these are non-clinical (benchtop) tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This device's evaluation is based on non-clinical mechanical testing, not clinical data requiring expert review for ground truth.
4. Adjudication Method for the Test Set
Not applicable. This evaluation is based on non-clinical mechanical testing, not clinical data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document presents non-clinical (benchtop) mechanical testing results, not clinical studies involving human readers or comparative effectiveness with AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This document does not pertain to an AI-powered device or algorithm. It concerns a physical medical implant.
7. The Type of Ground Truth Used
The "ground truth" for this type of evaluation is effectively established by the ASTM test standards (ASTM F1717-14 and ASTM F2129) themselves, which define acceptable methodologies and performance metrics for spinal implants. The device's performance is compared against these standards and to predicate devices to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set. The evaluation is based on mechanical testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI/ML algorithm that requires a training set.
§ 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.