(57 days)
The Facet FixxTM System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle. The Facet Fixx System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to S1 inclusive. The Facet Fixx System is indicated for treatment of any or all of the following: Degenerative disc disease (DDD) as defined by back pain of discogenic origins confirmed by history and radiographic studies, Degenerative disease of the facets with instability, Trauma (i.e. fracture or dislocation), Spondylolisthesis, Spondylolysis, Pseudoarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity.
The Facet FixxTM System is a posterior facet spinal fixation system consisting of screws with and without washers. The cannulated screw is offered partially or fully threaded in various diameter and length combinations.
This device is a spinal fixation system, not an AI/ML device. Therefore, the questions related to AI/ML device performance and study design are not applicable. The provided text describes the device, its intended use, materials, and a comparison to predicate devices, focusing on mechanical performance.
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Properties equivalent to predicate devices (Static and dynamic cantilever bending, axial pullout tests) | "The mechanical test results demonstrate the Facet FixxTM System to be substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a "test set" in the context of an algorithm. For mechanical testing, the number of samples tested for static/dynamic cantilever bending and axial pullout is not specified.
- Data Provenance: The mechanical testing was likely conducted in a laboratory setting, not with human patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable as this is a mechanical device, not an AI/ML diagnostic or prognostic system requiring expert-established ground truth.
4. Adjudication Method for the Test Set:
- Not applicable. Mechanical testing involves objective measurements rather than expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Not applicable. This is not an AI/ML device.
6. Standalone Performance Study:
- Not applicable. This is not an AI/ML algorithm. The performance established is the mechanical performance of the device itself.
7. Type of Ground Truth Used:
- Mechanical Testing Results: The "ground truth" here is the objective measurement of the device's mechanical properties (static and dynamic cantilever bending, axial pullout strength) against established ASTM standards (F2193 and F543) and comparable predicate devices.
8. Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that uses a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
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