(230 days)
The CastleLoc-P Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7). The System is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusions in patients with:
- degenerative disc disease (as defined by neck pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies),
- . spondylolisthesis,
- trauma (i.e. fractures or dislocations), .
- tumors, .
- . deformity (defined as kyphosis, lordosis, or scoliosis),
- failed previous fusion (pseudoarthrosis) .
- spinal stenosis. .
The CastleLoc-P Anterior Cervical Plate System is composed of plates, screws and lockers which are made from titanium alloy Ti-6A1-4V ELI (ASTM F136). These plates attach to the anterior cervical spine with a minimum of four screws per plate. The plates are offered in one-level, two-level, three-level, four-level fusion configurations (19~97mm). The plate screws are 3.5mm and 4.0mm diameter head screws. They are selftapping and self-drilling threaded. This device is provided as non-sterile.
This document is a 510(k) premarket notification for the CastleLoc-P Anterior Cervical Plate System. It describes the device and claims substantial equivalence to a predicate device based on performance testing. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Results) |
|---|---|
| Static compression bending strength | Performed, demonstrated substantial equivalence. |
| Static tension strength | Performed, demonstrated substantial equivalence. |
| Static torsion strength | Performed, demonstrated substantial equivalence. |
| Dynamic compression bending strength (Fatigue performance) | Performed according to ASTM F1717, demonstrated substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the mechanical performance tests. It mentions "a worst-case, cervical plate construct," implying a representative sample was tested.
The data provenance is from bench testing conducted by the manufacturer, L&K Biomed Company, Limited. There is no information regarding country of origin for the data beyond the manufacturer's location (Republic of Korea), or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is a premarket notification for a medical device (spinal intervertebral body fixation orthosis) based on mechanical (bench) performance data, not clinical data or data requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set
Not applicable. This is mechanical bench testing; there is no adjudication process involving human experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This document pertains to a physical medical device (spinal plate system), not an AI-assisted diagnostic or interpretation tool. Therefore, an MRMC study is irrelevant.
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.)
The "ground truth" for this type of device is established by ASTM (American Society for Testing and Materials) standards for mechanical performance, specifically ASTM F1717 for Spinal intervertebral body fixation orthoses. Compliance with these established industry standards serves as the benchmark for performance.
8. The sample size for the training set
Not applicable. This is not a study involving machine learning or AI where a training set would be used. The "training" in this context would refer to the design and engineering process of the device, which doesn't involve a quantifiable "training set" in the computational sense.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/ML algorithm. The design and manufacturing of the device would adhere to engineering principles and regulatory requirements to achieve the desired mechanical properties.
§ 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.