Search Results

The Statera-C™ Spinal 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 (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); 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. It 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 Statera-C™ Spinal System may be connected to the Rexious Spinal Fixation System, Statera™ Spinal System, and Statera-M™ Spinal System using corresponding connectors and/or transition rods.

The Statera-C™ Spinal System is a posterior cervico-thoracic fixation system intended to provide stabilization to promote fusion of the cervical spine and upper thoracic spine. The Statera-C™ Spinal System contains rods, polyaxial screws, hooks, set screws, connectors and cross connectors that are made from Titanium alloy and Cobalt Chrome alloy and are available in multiple shapes and sizes. Connecting components can be locked to the rod in various configurations to accommodate individual patient anatomy.

The provided text is related to an FDA 510(k) clearance for a spinal system and does not contain any information about an AI/ML-driven medical device. Therefore, I cannot extract the requested details about acceptance criteria, study performance, sample sizes, ground truth establishment, or expert involvement for an AI medical device from this document.

The document describes the Statera-C™ Spinal System as a physical medical device (rods, screws, hooks, etc.) used for spinal stabilization and fusion, with its performance demonstrated through non-clinical testing according to ASTM F1717 standards (static compression bending, dynamic compression bending, static torsion).

To address your request, information about an AI/ML medical device's performance study would need to be provided.

Ask a specific question about this device