(26 days)
The REGENT Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:
- Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
- Trauma (including fractures).
- Tumors
- Deformities or curvatures (including kyphosis, lordosis or scoliosis)
- Pseudoarthrosis
- Failed previous fusion
- Spondylolisthesis
- Spinal Stenosis
THIS DEVICE IS ONLY TO BE USED IN SKELETALLY MATURE PATIENTS.
WARNING: THIS DEVICE IS NOT INTENDED FOR SCREW ATTACHMENT OR FIXATION TO THE POSTERIOR ELEMENTS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE.
The REGENT Anterior Cervical Plate System is composed of various cervical plates and screws made from a Titanium alloy (Ti-6Al-4V, ASTM F-136/ISO 5832-3). The REGENT Anterior Cervical System contains multiple level plates (1 Level, 3 Level, and 4 Level) and various diameter screws that are either fixed or variable in nature. The plates and screws are anodized.
Here's an analysis of the provided text regarding the acceptance criteria and study for the REGENT Anterior Cervical Plate System:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission is for a modification to an already cleared device, primarily the addition of a self-drilling screw. The acceptance criteria are implicitly linked to demonstrating substantial equivalence to the predicate device (K091134), particularly in terms of mechanical performance and material properties. Since it's a modification, the "acceptance criteria" are not absolute performance thresholds but rather a demonstration that the new component (self-drilling screw) does not negatively impact the overall system's safety and effectiveness compared to the predicate.
| Acceptance Criteria Category (Implied for Substantial Equivalence to K091134) | Reported Device Performance (Proposed Device) |
|---|---|
| Mechanical Performance (Static Compression Bending and Torsion) | Substantially equivalent to the self-tapping screws used in the previously cleared REGENT Anterior Cervical Plate System (K091134), as per ASTM F1717. |
| Material Composition | Made from the same material as the predicate device's self-tapping screw: Ti-6Al-4V (ASTM F-136/ISO 5832-3). |
| Dimensional Characteristics (Screw Diameters & Lengths) | Provided in the same lengths and overall diameters (4.0mm and 4.5mm) as the predicate device's screws. |
| Interface with Plate (Screw to Plate Interface) | The proximal geometry of the subject self-drilling screw has an identical geometry to the self-tapping screw head (K091134), resulting in identical interfaces between the REGENT Anterior Cervical Plate. |
| Indications for Use | Same as the previously cleared system (K091134). |
| Anodization | Yes (Type II), same as the predicate. |
| Plate Dimensions | Same as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a numerical sample size for the mechanical tests. It states "The self drilling screws and the cleared REGENT Anterior Cervical Plates were tested..." This suggests a sufficient number of samples were tested to meet the requirements of ASTM F1717.
- Data Provenance: The data is based on non-clinical (mechanical) testing conducted by Custom Spine, Inc. The country of origin for the testing itself is not explicitly stated, but the company is based in Parsippany, NJ, USA. The study is prospective in the sense that the new self-drilling screws were manufactured and then tested.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a submission for a medical device which relies on objective mechanical testing data and comparison to a predicate device, not on expert-established ground truth for a diagnostic algorithm.
4. Adjudication Method for the Test Set
Not applicable. This refers to adjudication of discrepancies in human interpretation, which is not relevant for mechanical testing results.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. This is a mechanical device, not a diagnostic algorithm that involves human readers interpreting cases. Therefore, an MRMC study was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence is based on objective mechanical test standards (ASTM F1717) and direct comparison of material, design, and indications for use to a previously cleared predicate device.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning model; therefore, there is no training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, there is no ground truth for a training set to establish.
§ 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.