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510(k) Data Aggregation
(312 days)
RAPTOR FACET FIXATION SYSTEM
The Raptor™ Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. Raptor™ Facet Fixation System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1-S1 inclusive. The Raptor™ Facet Fixation 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 Raptor™ Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The system is comprised of the Facet Screw with Washer and instrumentation. The implant provides bilateral facet fixation, with or without bone graft, at single or multiple levels and can be used in conventional or percutaneous surgical procedures. The implants are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Raptor™ Facet Fixation System:
The provided documents describe a 510(k) premarket notification for a medical device (Raptor™ Facet Fixation System), which is primarily concerned with demonstrating substantial equivalence to previously cleared devices. This type of submission relies on nonclinical performance data, specifically mechanical testing, rather than studies involving human subjects or AI algorithms. As such, many of the typical questions regarding acceptance criteria for AI/diagnostic devices, such as sample size for test sets, expert adjudication, or MRMC studies, are not applicable in this context.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria are based on established consensus standards for spinal implants, and the performance is demonstrated by meeting the requirements of these standards. Exact numerical pass/fail thresholds are not explicitly detailed in the summary but are implied by adherence to the standards.
| Acceptance Criteria (based on consensus standards) | Reported Device Performance |
|---|---|
| Material Composition: Biocompatible and strong enough for intended use. | Identical to numerous other Alphatec Spine products cleared via 510(k), manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI). |
| Insertion/Removal Torque: Adequate torque capacity for surgical handling without failure. (Per ASTM F543-07) | Testing performed and satisfied requirements for posterior supplemental fixation. (Specific values not provided in summary but implied to meet standard.) |
| Torque to Failure (Torsional Yield Strength and Breaking Angle): Sufficient resistance to torsional forces experienced during and after implantation. (Per ASTM F543-07) | Testing performed and satisfied requirements for posterior supplemental fixation. (Specific values not provided in summary but implied to meet standard.) |
| Axial Pullout Strength: Sufficient resistance to dislodgement under axial forces. (Per ASTM F543-07) | Testing performed and satisfied requirements for posterior supplemental fixation. (Specific values not provided in summary but implied to meet standard.) |
| Static Bending: Ability to withstand static loads without permanent deformation or failure. (Per ASTM-F2193-02(2007)) | Testing performed and satisfied requirements for posterior supplemental fixation. (Specific values not provided in summary but implied to meet standard.) |
| Dynamic Bending: Ability to withstand cyclic loads over time without fatigue failure. (Per ASTM-F2193-02(2007)) | Testing performed and satisfied requirements for posterior supplemental fixation. (Specific values not provided in summary but implied to meet standard.) |
| Overall Performance: Satisfies requirements for posterior supplemental fixation. | The testing demonstrated that the performance characteristics satisfy the requirements of posterior supplemental fixation. |
| Substantial Equivalence: Similar in general design, intended use, and technological characteristics to predicate devices. | Determined to be substantially equivalent to predicate devices based on non-clinical performance data and engineering analysis. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this device and submission type. The "test set" here refers to mechanical test specimens (e.g., screws, washers), not patient data or images. The number of specimens tested for each mechanical test (e.g., insertion/removal torque, axial pullout, static/dynamic bending) would be detailed in the full test reports referenced by the ASTM standards, but not in this summary.
- Data Provenance: Not applicable. The data is from laboratory mechanical testing of physical device components, not from human subjects or clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth in this context is defined by objective physical measurements taken during mechanical testing according to standardized protocols (ASTM standards), not by human expert interpretation of clinical data. The "experts" would be the engineers and technicians performing the tests, qualified in mechanical engineering and testing procedures.
4. Adjudication Method for the Test Set
- Not applicable. Mechanical testing results are objective measurements against predefined acceptance criteria from the standards, not subjective interpretations requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms that assist human readers in interpreting clinical data. The Raptor™ Facet Fixation System is a physical implant, and its assessment focuses on mechanical safety and performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. There is no algorithm or AI component to this device.
7. The Type of Ground Truth Used
- Mechanical Integrity/Performance Standards: The ground truth is established by the specifications and acceptance criteria outlined in the referenced ASTM international consensus standards (ASTM F543-07, ASTM F2193-02(2007)). The device is deemed safe and effective if it meets or exceeds these pre-defined mechanical performance thresholds.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of this device. This is a physical implant, not an AI model requiring training data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set.
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