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The Innovasis Gibralt Spine System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the cervical spine (C1-C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Gibralt Spine System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Gibralt Spine System may be connected to the Innovasis Excella II® Spinal System, Excella 3® Spinal System and Excella III-D® Spinal Deformity System using rod-to-rod connectors and transitional rods. Refer to the specific system Instructions for Use for a list of their indications for use.

The Innovasis® Gibralt® Spine System is a posterior system intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the cervical, and/or upper thoracic spine. The system consists of a variety of sizes of rods, hooks, poly-axial screws and connecting components, which can be rigidly locked to the rod in various configurations. The Gibralt Spine System components are manufactured from titanium alloy (Ti6Al4V ELI per ASTM F136), with rods being available in both titanium alloy and cobalt chrome alloy (CoCr per ASTM F1537) options.

No modifications have been made to the design, materials or principles of operation when compared to the predicate.

This document describes the regulatory clearance (510(k)) for the Innovasis® Gibralt® Spine System. The focus of this clearance is on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical performance data for a novel AI/software medical device.

Therefore, the specific information about acceptance criteria, study design for proving device performance, sample sizes, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details as requested in the prompt cannot be found in this document. This is because the device (a spinal implant system) is a physical orthopedic device, not an AI or software medical device. The regulatory pathway for such devices typically relies on mechanical testing, material specifications, and comparison to existing predicate devices, rather than clinical performance studies involving AI algorithms.

The document explicitly states under "7. Performance Data":
"Nonclinical testing was performed on the subject Gibralt Spine System as part of K160697. The results demonstrated in K160697 that the subject Gibralt Spine System was substantially equivalent to the predicate. This information has been provided to Innovasis and no changes have been made to the system components to necessitate additional mechanical testing."

This confirms that the clearance is based on nonclinical mechanical testing ensuring the device's physical properties are equivalent to the predicate, not on a clinical study of its performance in human subjects, especially not in the context of an AI/software device.

Therefore, I cannot provide the requested information regarding acceptance criteria and study proving device performance in the context of an AI/software medical device from the provided text. The prompt's questions are tailored for a different type of medical device (AI/ML) than the one described in the provided FDA 510(k) clearance document.

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