(220 days)
The Azure Anterior Cervical Plate System is a temporary implant intended for anterior fixation to the cervical spine from C2 to C7 and indicated for: a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by patient history and radiographic studies); b) Spondylolisthesis; c) Trauma (i.e., fracture or dislocation); d) Spinal stenosis; e) Deformities (i.e., scoliosis, kyphosis, and/or lordosis); f) Tumor: g) Pseudoarthrosis; h) Revision of previous surgery
The Azure Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy (Ti6Al4V ELI per ASTM F136) with nitinol (per ASTM 2063) components that allow a surgeon to build a temporary anterior cervical implant construct. The system is attached to the anterior aspect of the vertebral body by means of screws to the cervical spine. The system consists of an assortment of screws, plates and associated instrumentation, which assists in the surgical implantation of the devices.
The provided document describes a 510(k) premarket notification for the Azure Anterior Cervical Plate System. This document is a regulatory submission for a medical device (a spinal implant), not an AI/ML device. Therefore, the questions related to AI/ML specific acceptance criteria, study design, and performance metrics (e.g., sample size for test set, data provenance, ground truth establishment, MRMC studies, standalone performance, training set size) are not applicable to this submission.
The document focuses on demonstrating substantial equivalence to a predicate device (K130825 - Azure Anterior Cervical Plate System, SE) by removing constrained screws from the system due to a field failure mode. The performance data presented is related to mechanical testing of the spinal implant, not the performance of an AI/ML algorithm.
Therefore, I cannot populate the requested table and information as it pertains to an AI/ML device.
However, I can extract the relevant information regarding the modification to the device and the reason for the change, which led to a performance test.
Summary of Device Modification and Performance Study:
The purpose of this 510(k) submission is the removal of constrained screws from the Azure Anterior Cervical Plate System. This change was initiated because the constrained screw constructs were experiencing "total fracture of the locking mechanism" in the field.
A modified Dynamic Axial Compression test was conducted in accordance with ASTM F1717 standard to compare the performance of constrained and semi-constrained screws.
Acceptance Criteria and Reported Device Performance (for mechanical testing, not AI):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Prevention of "total fracture of the locking mechanism" failure mode experienced with constrained screws. | Constrained screw constructs: were able to cause total fracture of the locking mechanism, "similar to the failures experienced in the field." This indicates that the constrained screws failed to meet the implied criteria of preventing this specific failure mode. |
| Semi-constrained screw constructs should not exhibit the same failure modes as constrained screws. | Semi-constrained screw constructs: "did not experience the same failure modes," thereby eliminating the risk of locking mechanism fracture. This indicates that the semi-constrained screws met the implied criteria of preventing the identified failure mode. In addition, simulated testing with semi-constrained screws was performed to validate a new recommended surgical technique, further demonstrating safety and effectiveness. |
| Device with semi-constrained screws should be safe and effective and substantially equivalent to the predicate. | The tests demonstrated that "the Azure system containing semi-constrained screws is safe and effective for use and is substantially equivalent or better than its predicate device Azure Anterior Cervical Plate System K130825." This general statement of equivalence and safety/effectiveness indicates that the system with semi-constrained screws met the overall regulatory acceptance for substantial equivalence after the modification. |
Regarding the specific questions about AI/ML studies:
- Sample size for the test set and data provenance: N/A (Not an AI/ML device)
- Number of experts used to establish the ground truth...: N/A (Not an AI/ML device)
- Adjudication method: N/A (Not an AI/ML device)
- Multi reader multi case (MRMC) comparative effectiveness study: N/A (Not an AI/ML device)
- Standalone (i.e. algorithm only...) performance: N/A (Not an AI/ML device)
- Type of ground truth used: N/A. The "ground truth" here is mechanical failure analysis (ASTM F1717 standard, field failure reports for constrained screws).
- Sample size for the training set: N/A (Not an AI/ML device)
- How the ground truth for the training set was established: N/A (Not an AI/ML device)
§ 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.