(87 days)
The Typhoon™ Facet Fixation Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from L1 to S1 inclusive.
The Typhoon™ Facet Screw Fixation System is indicated for treatment of any or all of the following: degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history and radiographic studies; degenerative disease of the facets with instability; Spondylolisthesis; Spondylolysis; Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; and trauma, including spinal fractures and/or dislocations.
For transfacet fixation, the Typhoon™ Facet Screw Fixation System is inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle.
The Typhoon™ Facet Fixation System is a posterior Facet spinal fixation system consisting of screws and washers, manufactured from titanium alloy (Ti6Al4V ELI; ASTM F136). The bone screws are designed to transfix the facet articular process in the spine to enhance spinal fusion and stability. The self-tapping screws are 4.5mm and 5.5mm in diameter. The 4.5mm screws are supplied in length ranging from 20mm to 60mm and the 5.5 mm screws range in length from 25mm to 60mm. Washers are available to increase the load bearing area of the screw in contact with the bone. These washers are designed to angulate about the head of the bone screw to provide optimal bony contact over a range of screw trajectories.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the Typhoon™ Facet Screw Fixation System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Testing) | Reported Device Performance (Typhoon™ Facet Screw Fixation System) |
|---|---|
| Mechanical testing according to ASTM F2193 | Performed and demonstrated substantial equivalence to predicate devices. |
| - Static bending | Performed |
| - Dynamic bending | Performed |
| - Static torsion | Performed |
| - Axial pullout | Performed |
| Mechanical testing according to ASTM F543 | Performed and demonstrated substantial equivalence to predicate devices. |
| - Static bending | Performed |
| - Dynamic bending | Performed |
| - Static torsion | Performed |
| - Axial pullout | Performed |
| Equivalence in intended use, indications, anatomic location, and material to predicate devices. | Documentation provided and accepted for substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include information on a "test set" in the context of clinical data or a data-driven device evaluation. The evaluation for this device was based on mechanical testing, not clinical trials with human subjects. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device's evaluation was based on mechanical testing according to established ASTM standards, not on expert-adjudicated clinical data.
4. Adjudication Method for the Test Set
This information is not applicable as the device's evaluation was based on mechanical testing, not clinical data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The evaluation was based on mechanical testing and comparison to predicate devices, not on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This is a physical medical device (facet screw), not a software algorithm.
7. The Type of Ground Truth Used
For the mechanical testing, the "ground truth" was defined by the established performance requirements and methodologies outlined in the ASTM F2193 and ASTM F543 standards. Compliance with these standards indicates the device's acceptable mechanical properties for its intended use. For the overall substantial equivalence determination, the ground truth was the demonstrated performance and characteristics of the predicate devices.
8. The Sample Size for the Training Set
This information is not applicable as the evaluation was based on mechanical testing of physical implants, not a data-driven training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
N/A