Search Results

The FacetBRIDGE® System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1. For transfacet fixation the screws are inserted posteriorly through the superior side of the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet joint, and into the pedicle. This system is intended for use only with bone graft material. This system is not to be used with bone cement. The FacetBRIDGE® System is indicated for treatment for any or all of the following:
· Pseudoarthrosis and failed previous which are symptomatic or which may cause secondary instability or deformity,
· 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,
· Trauma including spinal fractures and/or dislocations.

The FacetBRIDGE System is a set of screws used for translaminar or transfacet fixation in the spine as an adjunct to fusion. Each FacetBRIDGE construct consists of a screw and polyaxial washer both manufactured from Ti-6A1-4V ELI. The screw is cannulated to aid in placement via a guide wire. This system is not to be used with bone cement. The safety and effectiveness of using bone cement with this system has not been established.

This document describes the regulatory submission for the FacetBRIDGE® System, a spinal facet screw system. It focuses on non-clinical (bench) performance data rather than clinical studies or those involving AI. Therefore, most of the requested information regarding AI-specific criteria, human expert involvement, and ground truth establishment from clinical data is not available in the provided text.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that non-clinical performance bench testing was conducted to support substantial equivalence. The acceptance criterion is that the device "demonstrates the device is substantially equivalent to legally marketed predicate devices." The reported performance is that the FacetBRIDGE® System met this requirement.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable and not provided. The study conducted was non-clinical bench testing, not a clinical test set with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable and not provided. The "ground truth" in this context would refer to the performance standards set by the ASTM methods for bench testing, not expert clinical consensus.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are relevant for clinical studies involving human interpretation or outcome assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable. This device is a physical spinal implant system, not a software algorithm or AI device.

7. The Type of Ground Truth Used

For the non-clinical performance data, the "ground truth" or reference standard would be the engineering specifications and performance standards defined by the ASTM (American Society for Testing and Materials) standards referenced (e.g., ASTM F1264-14, ASTM F543e1).

8. The Sample Size for the Training Set

This information is not applicable and not provided. The study conducted was non-clinical bench testing; there was no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

This information is not applicable. There was no training set for an AI model. For the non-clinical testing, the performance standards (ground truth) were established by the relevant ASTM test methods.

Ask a specific question about this device