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510(k) Data Aggregation
(81 days)
The 3.8mm CS Facet Compression Device 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 and failed previous fusion. The intended use of the 3.8mm CS Facet Compression Device is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The 3.8mm CS Facet Compression Device is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to S1.
The 3.8mm CS Facet Compression Device is a double-helix screw with a compressionlocking collar, and is provided with or without a self-retaining washer. It is available in various length ranges fabricated from either Titanium 6Al-4V, which meets the requirements of ASTM F-136 or stainless steel, which meets the requirements of ASTM F-138.
This document describes the 510(k) summary for the Triage Medical, Inc. 3.8mm CS Facet Compression Device. This device is a facet screw intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints.
The provided text describes a medical device submission for regulatory clearance (510(k) application) and details related to its non-clinical performance and a comparison to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria related to AI/software performance or diagnostic accuracy. The performance data mentioned is focused on mechanical and biocompatibility aspects, not AI-driven predictive or diagnostic capabilities.
Therefore, many of the requested sections about acceptance criteria, study details for AI performance, sample sizes for AI training/testing, ground truth establishment, and MRMC studies cannot be generated from the given text.
Here's the information that can be extracted and a clear statement about what is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Met) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Satisfy functional performance requirements | "Mechanical and biomechanical testing have established that the devices satisfies functional performance requirements." |
| Biocompatibility | Made from biocompatible materials; meet ASTM standards for Titanium 6Al-4V ELI (F-136) or surgical grade Stainless Steel (F-138). | "The 3.8mm CS Facet Compression Device is made from either Titanium 6Al-4V ELI, which meets the requirements of ASTM F-136 or surgical grade Stainless Steel, which meets the requirements of ASTM F-138." |
| Substantial Equivalence | Similar in basic design, materials, and intended use to predicate device (NuVasive™ 3.5mm Triad™ Facet Screw System K020411). | "The 3.8mm CS Facet Compression Device is similar in basic design, materials and intended use to the NuVasive™ 3.5mm Triad™ Facet Screw System cleared under 510(k) K020411.""The 3.8mm CS Facet Compression Device is similar in materials, design, construction and mechanical performance to the predicate devices." |
| Safety and Effectiveness | Safe when used as indicated; accurately perform stated intended use. | "Documentation provided, and test results demonstrate that the 3.8mm CS Facet Compression Device is substantially equivalent to the predicate devices and is capable of safely and accurately performing the stated intended use." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The document refers to non-clinical mechanical and biocompatibility testing, not clinical studies or AI algorithm testing with a "test set" in the common sense for AI.
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 information is not available in the provided text. The device is a physical implant, and its evaluation relies on engineering tests and material standards, not expert-derived ground truth for AI performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text.
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 information is not available in the provided text. This device is not an AI-driven diagnostic or assistive tool, so an MRMC study comparing human readers with and without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not available in the provided text. This device is a physical facet screw, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the mechanical and biocompatibility performance, the "ground truth" would be established by engineering standards and test methodologies (e.g., ASTM standards for materials, recognized biomechanical testing protocols). This is not the typical "ground truth" concept as applied to AI/diagnostic devices.
8. The sample size for the training set
This information is not available in the provided text. There is no mention of an AI algorithm or a training set.
9. How the ground truth for the training set was established
This information is not available in the provided text. There is no mention of an AI algorithm or a training set.
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