(160 days)
The CoreLink Lateral Plate System (LPS) is intended for use as a laterally placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The CoreLink LPS is designed to provide temporary stability until fusion is achieved. It is intended for lateral or anterolateral lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Alternatively, the CoreLink LPS may remain attached to CoreLink Lateral lumbar interbody devices after implantation. In this configuration the CoreLink LPS must only be used to treat patients with degenerative disk disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels.
The CoreLink Lateral Plate System (LPS) is comprised of a lumbar plate and screws. The lumbar plate has a sliding, spring loaded lock tab for each screw position to prevent back-out of the screw. The plate is available in a 2-screw or 4-screw version and in multiple lengths for single level fixation. The screws are available in various lengths and 2 diameters.
This document is a 510(k) premarket notification for a medical device, specifically a Spinal Intervertebral Body Fixation Orthosis. As such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its performance against a set of acceptance criteria for diagnostic or AI-driven systems.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these relate to AI/diagnostic device validation, are not applicable or extractable from this document.
The document discusses mechanical performance testing to demonstrate that the device is sufficient for its intended use and substantially equivalent to legally marketed predicate devices. However, this is not the type of performance data typically associated with the "device performance" and "acceptance criteria" structure you are asking about for AI/diagnostic devices.
Here's an attempt to fill in relevant sections based on the provided text, while explicitly noting where the requested information is not applicable due to the nature of the device (a spinal fixation system, not a diagnostic AI):
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test Mode | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Static axial compression bending per ASTM F1717 | Not explicitly stated as numerical acceptance criteria, but implicitly to demonstrate "sufficient strength for its intended use" and "substantially equivalent to legally marketed predicate devices." | "The strength of the Lateral Plate System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." |
| Mechanical Performance | Static torsion per ASTM F1717 | (Same as above) | (Same as above) |
| Mechanical Performance | Dynamic axial compression bending fatigue per ASTM F1717 | (Same as above) | (Same as above) |
| Mechanical Performance | Static pull apart testing | (Same as above) | (Same as above) |
| Biocompatibility | Material Compliance | Materials made from Ti-6Al-4V ELI in accordance with ASTM F136 and Nitinol per ASTM F2063. | "Lateral Plate System plates are made from Ti-6Al-4V ELI in accordance with ASTM F136, and the lock springs are manufactured from Nitinol per ASTM F2063." |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes mechanical testing of a physical implant rather than a study involving human or animal subjects that generate data in the context of AI/diagnostic device validation. The "tests" refer to laboratory mechanical assessments of the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable. Ground truth, in the context of diagnostic or AI systems, is not relevant for the mechanical testing of a spinal fixation device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used for expert review and consensus in diagnostic or AI studies and are not relevant for mechanical device 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
There was no MRMC comparative effectiveness study done. This device is a passive spinal implant, not an AI-assisted diagnostic or treatment system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There was no standalone algorithm performance study done. This device is a passive spinal implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable. "Ground truth" in the diagnostic/AI sense is not established for the mechanical properties of a spinal implant. The "truth" for this device lies in its adherence to established ASTM standards for mechanical strength and material composition.
8. The sample size for the training set
This information is not applicable. There is no "training set" as this device is a physical implant, not an AI model requiring machine learning.
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set for an AI model, there is no ground truth to establish for it.
§ 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.