(74 days)
The 4.5mm BONE-LOK® Facet Screw is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis or failed previous fusion.
The intended use of the 4.5mm BONE-LOK® Facet Screw is 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. The 4.5mm BONE-LOK® Facet Screw is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to Sl.
The 4.5mm BONE-LOK® Facet Screw is a double-helix screw with a compressionlocking collar and a self-retaining washer. It is available as a 30-40mm range device fabricated from either stainless steel, which meets the requirements of ASTM F-138, or Titanium 6Al-4V, which meets the requirements of ASTM F-136.
This appears to be a 510(k) summary for a medical device (a facet screw), not an AI/ML medical device. Therefore, the questions related to AI/ML device performance, such as acceptance criteria based on AI/ML metrics, sample sizes for test/training sets, expert ground truth, MRMC studies, and standalone performance, are not applicable.
The provided document describes a 4.5mm BONE-LOK® Facet Screw and its substantial equivalence to a predicate device for safety and effectiveness. The "acceptance criteria" in this context would generally refer to the successful demonstration of this substantial equivalence through non-clinical performance data (mechanical and biomechanical testing) and biocompatibility, rather than clinical performance metrics for an AI algorithm.
However, I will extract information related to "acceptance criteria" and "study" as best as possible from the provided context, interpreting "acceptance criteria" as the requirements for substantial equivalence and "study" as the non-clinical performance evaluation.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Non-Clinical) |
|---|---|
| Material Composition and Safety | Made from surgical grade Stainless Steel (ASTM F-138) or Titanium 6Al-4V ELI (ASTM F-136). These materials are currently used in legally marketed orthopedic devices, demonstrating biocompatibility. |
| Design and Construction Similarity | "Similar in materials, design, construction... to the predicate devices." |
| Mechanical Performance Requirements | "Mechanical and biomechanical testing have established that the devices satisfies functional performance requirements and is safe when used as indicated." |
| Functional Performance Requirements | "Mechanical and biomechanical testing have established that the devices satisfies functional performance requirements and is safe when used as indicated." |
| Intended Use Fulfillment | "Literature, other documentation provided, and test results demonstrate that the 4.5mm BONE-LOK® Facet Screw is substantially equivalent to the predicate devices and is capable of safely and accurately performing the stated intended use." |
Explanation of the "Study" that Proves the Device Meets Acceptance Criteria:
The study proving the device meets the (implied) acceptance criteria is a non-clinical performance evaluation consisting of:
- Mechanical Testing: To assess the physical properties and performance under stress.
- Biomechanical Testing: To evaluate how the device performs within a biological system context (e.g., in terms of stability, load-bearing).
- Biocompatibility Assessment: Based on the use of well-established, legally marketed surgical-grade materials (Stainless Steel and Titanium alloy) that meet ASTM standards (F-138 and F-136, respectively).
These tests collectively demonstrate that the device satisfies functional performance requirements and is safe for its intended use, establishing substantial equivalence to the predicate device.
Items 2-9 (Not Applicable to this type of device submission):
The following points are specifically relevant to the evaluation of AI/ML medical devices, which typically involve software algorithms processing data for diagnostic or prognostic purposes. The provided document concerns a Class II mechanical implant (a facet screw), not an AI/ML device. Therefore, these questions are not applicable in this context.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective) - Not applicable for a mechanical implant.
- 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) - Not applicable for a mechanical implant.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set - Not applicable for a mechanical implant.
- 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 - Not applicable for a mechanical implant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done - Not applicable; this is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc) - Not applicable for a mechanical implant.
- The sample size for the training set - Not applicable; this is not an AI/ML model.
- How the ground truth for the training set was established - Not applicable; this is not an AI/ML model.
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