(134 days)
The Spinal USA 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 with or without bone graft, at single or multiple levels, of any or all of the following spinal levels L1 to S1 (inclusive): Spondylolisthesis, Spondylolysis, Pseudoarthrosis or failed previous 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 Spinal USA Facet Screw System consists of a assortment of screws. Each are made of medical grade titanium alloy conforming to such standards as ASTM F-136 and/or ISO 5832-3. The screws will be provided non-sterile.
The provided text describes a medical device, the "Spinal USA Facet Screw System," and its mechanical testing to demonstrate substantial equivalence to a predicate device. It is a 510(k) premarket notification summary.
Here's a breakdown of the requested information based on the provided text, while noting that many of the requested items are not applicable to this type of device and submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance (ASTM F1264) | Sufficient strength and fatigue resistance to stabilize the facet joint during fusion healing and exceed physiological loads. | "Comparable mechanical performance to the predicate device tested in direct side by side testing." "Demonstrated strengths that exceed all physiological loads and accepted criteria along with spinal column through the facet joint with significant margin of safety provided." "Performed comparably to the commercially available predicate and demonstrated sufficient strength and fatigue resistance to stabilize the facet joint during fusion healing." "Performed well above the acceptance criteria and will adequately stabilize a fusion segment." |
| Equivalence to Predicate Device | Substantially equivalent in intended use, indications, anatomic sites, performance, and material of manufacture. | "Documentation was provided which demonstrated the Facet Screw System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture." "The screws are available in different diameters and lengths to accommodate patient anatomy and are substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a distinct "test set" sample size for mechanical testing in the way that would apply to clinical performance studies (e.g., number of patients or images). For mechanical testing, the "sample size" would refer to the number of individual screws and/or constructs tested for each mechanical test condition (Axial Pullout, Torque to Failure, Static 3-Point Bending, Dynamic 3-Point Bending). This specific number is not provided in the summary.
- Data Provenance: The mechanical testing was "performed per ASTM F1264." This indicates it was laboratory testing conducted according to a recognized standard, not data from human subjects or clinical trials. Therefore, concepts like "country of origin" or "retrospective/prospective" are not applicable here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- N/A. This information is not relevant for a mechanical testing study of a medical implant and is not provided in the document. Ground truth as typically defined in AI/clinical studies (e.g., expert consensus on medical images or patient outcomes) does not apply to this type of engineering performance evaluation.
4. Adjudication Method for the Test Set
- N/A. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert opinions, typically in clinical studies or for establishing ground truth for AI model training/testing. This is not applicable to mechanical testing data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This was not a MRMC comparative effectiveness study. This type of study involves multiple human readers evaluating cases, often with and without AI assistance, to measure diagnostic performance. The submission describes mechanical testing of a surgical implant.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
- N/A. This does not involve an algorithm or AI. It is a physical medical device (facet screw system) undergoing mechanical performance testing.
7. Type of Ground Truth Used
- The "ground truth" for this engineering study is defined by the measured mechanical properties of the device when subjected to standardized tests (ASTM F1264) and compared against pre-defined acceptance criteria, as well as against the mechanical performance of a predicate device. It's an objective measurement against engineering standards, not expert consensus, pathology, or outcomes data in a clinical sense.
8. Sample Size for the Training Set
- N/A. This device does not involve a "training set" in the context of machine learning or AI. The design and manufacturing processes are informed by engineering principles and standards, not data training.
9. How the Ground Truth for the Training Set Was Established
- N/A. As there is no training set for an AI model, this question is not applicable.
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