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510(k) Data Aggregation
(220 days)
Azure Anterior Cervical Plate System
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)
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(42 days)
AZURE ANTERIOR CERVICAL PLATE SYSTEM
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.
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