(151 days)
The Resolute Facet Screw System is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels: Spondylolisthesis, Pseudoarthrosis or failed previous fusions which are symptomatic; Degenerative Disc Disease (DDD) as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.
The Resolute Facet Screw System is comprised of various sized single-use, non-sterile facet screws that are designed to provide bilateral transfacet fixation of the lumbar facet joints. The system consists of titanium alloy (6AL-4v-EU per ASTM F136) screws in fully threaded and partially threaded designs, both of which are cannulated.
This document describes the Resolute™ Facet Screw System, a medical device designed for spinal stabilization, and its regulatory submission (510(k)). The provided text does not describe an AI/ML powered medical device, an imaging device, or a study that uses acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC).
Instead, this is a 510(k) summary for a traditional medical implant (facet screw system) where "acceptance criteria" and "performance data" refer to mechanical and material testing to demonstrate substantial equivalence to predicate devices. Therefore, many of the requested fields regarding AI/ML device performance, reader studies, ground truth establishment, and training sets are not applicable.
Here's an analysis of the provided information in the context of the device:
1. A table of acceptance criteria and the reported device performance:
The document states: "Cantilever testing and engineering analysis was completed on the Resolute Facet Screw System." and "No new technical characteristics are being introduced with this product."
This implies that the acceptance criteria for the Resolute™ Facet Screw System would be to meet or exceed the mechanical performance (e.g., stiffness, strength) of the predicate devices (Spineology® Capture™ Facet Screw System (K092464) and NuVasive® Triad® Facet Screw System (K020411)) as demonstrated through cantilever testing and engineering analysis. The specific numerical acceptance criteria (e.g., minimum loads, deflections, fatigue cycles) are not provided in this summary but would have been part of the full submission.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Mechanical performance (e.g., stiffness, strength, fatigue resistance) equivalent to or better than predicate devices, as demonstrated by cantilever testing and engineering analysis. | "Cantilever testing and engineering analysis was completed on the Resolute Facet Screw System." Conclusion: "The overall technology characteristics and mechanical performance data lead to the conclusion that Resolute Facet Screw System is substantially equivalent to the predicate devices." |
| Material properties (titanium alloy 6AL-4v-ELI per ASTM F136) equivalent to predicate devices. | "The Resolute Facet Screw System screws are manufactured from titanium alloy (6AL-4v-ELI per ASTM F136), similar to the referenced predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
For a mechanical device like this, the "test set" would refer to the number of screws or test constructs used in the mechanical testing. This information is not provided in the given 510(k) summary. Data provenance is not applicable for this type of mechanical testing, as it's performed in a laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This question is not applicable. The "ground truth" for a mechanical device is established by physical laws and engineering standards, not expert clinical consensus. The testing would be conducted by engineers in a lab.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This question is not applicable. Adjudication methods are used for clinical or diagnostic data, not for mechanical testing of an orthopedic implant.
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:
This question is not applicable. This device is a surgical implant, not an imaging or diagnostic AI device. No reader studies would be performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable as this is a mechanical medical device, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is based on engineering principles, material science, and relevant ASTM standards for mechanical testing of spinal implants. It's not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set:
This question is not applicable. There is no "training set" for a mechanical medical device in the context of the provided information.
9. How the ground truth for the training set was established:
This question is not applicable for the same reason as above.
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