Search Results
Found 1 results
510(k) Data Aggregation
(42 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) and 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 instrumentation provided to facilitate implantation are Class I, manual orthopedic standard surgical instruments.
The provided text describes the AZURE Anterior Cervical Plate System, a medical device, and its premarket notification. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing.
Here's an analysis of the provided information, framed by your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance |
|---|---|---|
| Static Torsion Test | ASTM F1717-12 | "Test results demonstrated that the new, proposed device is substantially equivalent to the predicate device." |
| Static Axial Compression Bending Test | ASTM F1717-12 | "Test results demonstrated that the new, proposed device is substantially equivalent to the predicate device." |
| Dynamic Axial Compression Bending Test | ASTM F1717-12 | "Test results demonstrated that the new, proposed device is substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of devices tested) for the mechanical tests. The data provenance is non-clinical, meaning it's from laboratory testing of the device itself, not from human or animal subjects. The testing was conducted in a laboratory setting to ASTM F1717-12 standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable in this context. The "ground truth" for mechanical testing is established by engineering standards and measurements, not by expert medical consensus. The performance is objectively measured against the criteria defined by ASTM F1717-12.
4. Adjudication Method for the Test Set
This is not applicable for non-clinical mechanical testing. Adjudication typically refers to the process of resolving disagreements among experts when establishing ground truth for clinical data. Here, performance is determined by objective measurements meeting predefined engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of a diagnostic or assistive AI system on human reader performance for interpretation of medical images or data. The AZURE Anterior Cervical Plate System is a physical implant, not a diagnostic or AI-driven system.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. Again, this device is a physical implant, not an algorithm. The performance evaluation is based on its mechanical properties.
7. The Type of Ground Truth Used
The "ground truth" for the performance study (mechanical testing) is the established engineering specifications and performance thresholds defined within the ASTM F1717-12 standard. The device's ability to withstand static torsion, static axial compression bending, and dynamic axial compression bending according to this standard is the objective measure of its performance.
8. The Sample Size for the Training Set
This is not applicable. Training sets are used in the development of AI algorithms. This document is for a physical medical device (an anterior cervical plate system), not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for a physical implant.
Ask a specific question about this device
Page 1 of 1