(206 days)
The CoreLink ANODYNE® 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 ANODYNE® Anterior Cervical Plate System is comprised of an assortment of titanium alloy plates and screws that act to stabilize the spine during the intervertebral fusion process. The ANODYNE® Anterior Cervical Plate System is manufactured from anodized Ti-6AI-4V ELI in accordance with ASTM F136. The two-screw per level plates are available in lengths of 13-30mm (1-level), 26-46mm (2-level), 46-70mm (3-level), and 60-100mm (4-level).
The provided text describes the 510(k) summary for the ANODYNE® Anterior Cervical Plate System, focusing on its substantial equivalence to predicate devices rather than a standalone clinical study proving the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity.
Therefore, many of the requested sections regarding acceptance criteria, performance metrics, ground truth, sample sizes, and expert adjudication are not applicable or cannot be extracted from the provided document, as it pertains to a mechanical device and a substantial equivalence review, not an AI/diagnostic software study.
Here's a breakdown based on the provided text, indicating what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from performance standards) | Reported Device Performance |
|---|---|
| Adherence to ASTM F1717 performance standards | All applicable requirements were met, indicating substantial equivalence to predicate devices. |
| Static compression bending | Testing performed. |
| Static torsion | Testing performed. |
| Dynamic compression bending | Testing performed. |
| Finite Element Analysis (FEA) | Performed. |
Explanation: The "acceptance criteria" here are defined by adherence to ASTM F1717 performance standards, which cover mechanical testing for spinal implant assemblies. The reported performance is that the device met these standards, demonstrating substantial equivalence to its predicate devices in terms of mechanical behavior. Specific quantitative values for these tests are not provided in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of this device's mechanical testing for 510(k) clearance. The "test set" refers to the physical devices undergoing mechanical tests, not patient data.
- Data Provenance: Not applicable. The "data" comes from engineering and mechanical testing, not clinical patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. Ground truth for mechanical performance is established through standardized testing protocols (ASTM F1717) and engineering analysis, not expert consensus on clinical data.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Mechanical testing results are objectively measured and analyzed against predetermined standards, not adjudicated by human readers.
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. This is a medical device (spinal plate system), not AI software or an imaging diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for this device's performance is established by validated mechanical testing methodologies and engineering principles as defined by the ASTM F1717 standard. The "truth" is that the device withstands specified loads and forces according to these standards, demonstrating mechanical equivalence to previously cleared devices.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of mechanical device testing for substantial equivalence.
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.