(29 days)
When intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine.
The use of polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. Polyaxial screws are not intended to be placed in the cervical spine.
This system can be used independently or in conjunction with Exactech 5.5mm or 6.0mm rod-based Thoraco-Lumbar Pedicle Screw Systems.
Gibralt Rod-to-Rod Cross Connectors represent a line extension to the Gibralt Spinal System. The Gibralt Spinal System is a top-loading spinal fixation system comprising a range of polyaxial screws, rods, hooks, and various connectors. Gibralt Spinal System devices are used by surgeons to immobilize and stabilize spinal segments as an adjunct to fusion of the cervical and/or upper thoracic spine.
As with other Gibralt System cross-connectors, Gibralt Rod-to-Rod Cross Connectors are designed to increase the rigidity of Gibralt Spinal System constructs. Gibralt Rod-to-Rod Cross Connectors can be used at any point along a Gibralt Spinal System rod, where previous cross connectors can only be used at connection points in a system construct. This line extension is proposed to provide surgeons with additional options for stabilizing and/or immobilizing spinal segments as an adjunct to spinal fusion.
Like all Gibralt Spinal System components, the proposed Gibralt Rod-to-Rod Cross Connectors are manufactured from titanium alloy per ASTM F136. All implantable Gibralt Spinal System components are provided non-sterile, and must be steam sterilized by the hospital prior to use.
This document describes a Special 510(k) submission for Exactech® Gibralt® Rod-to-Rod Cross Connectors, an extension to the Gibralt Spinal System. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device through mechanical bench testing.
Here's the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test) | Performance Outcome |
|---|---|
| Static compression bending (ASTM F1717-13) | Assessed; deemed substantially equivalent to predicate |
| Dynamic compression bend strength (ASTM F1717-13) | Assessed; deemed substantially equivalent to predicate |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for the bench testing. It indicates the tests were conducted per ASTM F1717-13, a standard for testing spinal fixation devices, which would implicitly define testing protocols and sample sizes. The data provenance is mechanical bench testing, not human or animal data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this device is based on mechanical properties and performance against established ASTM standards, not on expert clinical interpretation.
4. Adjudication method for the test set
Not applicable, as this was mechanical bench testing against a standard, not a clinical study requiring human adjudication.
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 a medical device (spinal implant components), not an AI-assisted diagnostic or predictive tool, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable as this is a medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" is defined by the performance requirements outlined in ASTM F1717-13 for static compression bending and dynamic compression bend strength, as well as comparison to the performance of the predicate device (Gibralt Spinal System).
8. The sample size for the training set
Not applicable. This is a medical device, not a machine learning model; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of medical device submission.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.