(69 days)
The NuVasive® Facet Screw System is intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The NuVasive Facet Screw System is indicated for facet fixation, with or without bone graft, at single or multiple levels, from C2 to S1 (inclusive). The Facet Screw System is indicated for treatment of any or all of the following:
(a) pseudoarthrosis and failed previous fusion;
(b) spondylolisthesis;
(c) spondylolysis;
(d) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies;
(e) degeneration of the facets with instability; and
(g) fracture.
The NuVasive Facet Screw System is intended for conventional or percutaneous surgical placement.
The NuVasive Facet Screw System consists of fully threaded and partially threaded screws designed to compact juxtaposed facet articular processes to enhance spinal fusion and stability. The screws and washers are fabricated from anodized titanium alloy (Ti-6Al-4V) and are supplied in various sizes to accommodate the various anatomy of the spine.
The NuVasive Facet Screw System is a medical device intended to stabilize the spine as an aid to fusion through immobilization of the facet joints. The acceptance criteria and the study proving the device meets these criteria are detailed below.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Composition Equivalence | The device is fabricated from anodized titanium alloy (Ti-6Al-4V), which is stated to be equivalent to predicate devices. |
| Design Equivalence | The device design (fully threaded and partially threaded screws) is compared to predicate devices and found to be substantially equivalent. |
| Intended Use Equivalence | The intended use (stabilize the spine as an aid to fusion through immobilization of facet joints, C2 to S1, for specified conditions) is consistent with predicate devices. |
| Function Equivalence | The function of compacting juxtaposed facet articular processes to enhance spinal fusion and stability is substantially equivalent to predicate devices. |
| Range of Sizes Equivalence | The device is supplied in various sizes to accommodate various anatomy of the spine, similar to predicate devices. |
| Static Cantilever Bending Performance (guided by ASTM F1717-04) | The device meets or exceeds the performance of the predicate device. |
| Dynamic Cantilever Bending Performance (guided by ASTM F1717-04) | The device meets or exceeds the performance of the predicate device. |
| Overall Substantial Equivalence | The device is shown to be substantially equivalent to legally marketed predicate devices, and safe and effective for its intended use. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state a "test set" in the context of clinical trials with human subjects. The performance data is derived from nonclinical testing, specifically mechanical testing. Therefore, there is no information on human subject sample size, country of origin, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for nonclinical mechanical testing is established by engineering standards and measurements, not expert clinical interpretation.
4. Adjudication method for the test set
Not applicable. This concept is relevant for clinical studies involving expert review, not for mechanical bench testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a surgical implant, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical implant, not an algorithm.
7. The type of ground truth used
For the nonclinical performance testing, the "ground truth" was established by engineering standards and measurements as defined by the ASTM F1717-04 guideline for static and dynamic cantilever bending testing. The performance of the predicate device served as the benchmark for comparison.
8. The sample size for the training set
Not applicable. This device is a surgical implant; there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for this type of device, no ground truth was established for it.
N/A