(21 days)
The 4.5mm LS Facet Compression Device with Polymer Washer is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by neck and/or 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 LS Facet Compression Device with Polymer Washer 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 LS Facet Compression Device with Polymer Washer is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1.
The 4.5mm LS Facet Compression Device is a double-helix screw with a compressionlocking collar. It is available as 4.5mm diameter device and is obtainable in a 30-40mm length range. The 4.5mm LS Facet Compression Device with Polymer Washer is intended for single use only.
Devices are provided "STERILE" and are double-pouched in Tyvek®ffilm pouches and sterilized by gamma radiation.
The provided text describes a 510(k) premarket notification for a medical device, the "4.5mm LS Facet Compression Device with Polymer Washer." This submission focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a standalone study with acceptance criteria and device performance metrics in the way a clinical trial or algorithm validation study would.
Therefore, many of the requested elements for an AI/algorithm-focused study are not directly applicable or present in this document. I will extract the information that is available and indicate where the information is not provided.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
This document does not present quantitative acceptance criteria or detailed device performance metrics in the format of a clinical study or algorithm validation. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to a predicate device, as determined by mechanical testing and biocompatibility.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (materials meet specified standards) | Titanium meets ASTM F-136, Stainless steel meets ASTM F-138. Polymer washer meets USP Class VI and ISO 10993-1. |
| Functional Performance (mechanical similarity to predicate) | "Performance test results indicate that the device is safe and satisfies functional performance requirements when used as indicated." |
| Substantial Equivalence to Predicate Device (BONE-LOK® 4.5mm Facet Screw, K043351) | "The test results demonstrate that the modified 4.5mm LS Facet Compression Device with Polymer Washer is substantially equivalent to the predicate device and is capable of safely and accurately performing the stated intended use." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document is for a mechanical medical device, not a data-driven AI/algorithm. The "test set" would refer to the mechanical tests performed on the device. However, specific sample sizes for these tests are not provided in this summary. The data provenance would be from laboratory testing of materials and device mechanics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of ground truth.
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
Not applicable. This is not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical performance and biocompatibility, the "ground truth" is defined by established material standards (e.g., ASTM, USP, ISO) and laboratory-based functional performance tests compared against the predicate device.
8. The sample size for the training set
Not applicable. This is a mechanical medical device, not an AI/algorithm that requires training data.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
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