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 fusions 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® System construct consists of a screw and optional polyaxial washer both manufactured from Ti-6AI-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 is a 510(k) premarket notification for the FacetBRIDGE® System, specifically for a line extension that includes an additional washer design. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study of the device itself.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria is largely not applicable/provided in this document in the context of device performance as typically defined for new medical devices requiring extensive clinical data.

Here's what can be extracted based on the provided text, and where information is missing:

1. A table of acceptance criteria and the reported device performance

Explanation: The document states that the purpose of the submission is to introduce a line extension and that the non-clinical performance bench testing conducted was to support substantial equivalence. The "performance" described here is in the context of ensuring the new washer design does not negatively impact existing functionality or mechanical strength. No specific quantitative performance metrics (e.g., maximum load, fatigue cycles, specific dimensional tolerances) or their corresponding acceptance thresholds are provided in this summary. Instead, a general statement of compliance or completion of these tests is made.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not specified. The document mentions "functional verification study utilizing sawbones" but does not give a sample size (e.g., number of sawbones tested, number of devices tested on sawbones).
• Data Provenance: Not specified. Given it's non-clinical bench testing, geographical provenance is less relevant than for clinical data. The study appears to be proprietary data from the manufacturer (LDR Spine USA, Incorporated). It is a non-clinical, prospective bench study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not applicable/provided. This was a non-clinical bench study. Ground truth in this context would typically refer to objective measurements from engineering tests rather than expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable/provided. This was a non-clinical bench study.

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

• MRMC Study: No. This is not applicable to a non-clinical submission for a spinal implant. It's a physical medical device, not an AI or diagnostic software.

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

• Standalone Performance Study: No. This is not applicable to a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: For the non-clinical bench testing, the "ground truth" would be established by engineering specifications, material standards, and verifiable physical measurements. For example, during dimensional analysis, "ground truth" would be the engineering drawings and metrology results. For endotoxin testing, it would be a validated assay and defined pass/fail criteria.

8. The sample size for the training set

• Training Set Sample Size: Not applicable/provided. There is no mention of a "training set" as this is not an AI/machine learning device. The non-clinical tests would involve specific samples for each test type mentioned.

9. How the ground truth for the training set was established

• Ground Truth for Training Set Establishment: Not applicable/provided, as there is no "training set."

Summary of Device and Study Context:

This 510(k) submission, K161798 for the FacetBRIDGE® System, is for a line extension (new washer design) to an already cleared device. The regulatory strategy applied here is to demonstrate "substantial equivalence" to a predicate device (K152137), meaning the new design does not introduce new questions of safety or effectiveness. For such a submission, extensive de novo clinical trials are often not required. The clinical performance data section explicitly states: "Clinical testing was not required to demonstrate substantial equivalence." The non-clinical data primarily consists of engineering analysis, functional verification using sawbones, and endotoxin testing, which are standard for changes to mechanical devices to confirm continued safety and performance without needing full clinical re-validation.

Ask a specific question about this device