(79 days)
The VERTE-SPANTM Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-SPAN™ Spinal System is to be used with supplemental fixation. Specifically, the VERTE-SPAN™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, Titanium DYNALOK™ CLASSIC Spinal System, LAURAIN DEWALD Anterior Fixation System, Titanium TSRH® Spinal System, Titanium CD HORIZON® Spinal System or the Titanium GDLH® Spinal System. Additionally, the VERTE-SPAN™ device is intended to be used with bone graft.
The VERTE-SPAN™ device consists of titanium cylinders of various lengths and diameters, endplates and break-off set screws. The assembled VERTE-SPAN™ device consists of five components (one hollow metal cylinder, two endplates and two set screws). The VERTE-SPAN™ components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The VERTE-SPAN™ Spinal System implant components are made of medical grade titanium alloy (Ti-6A1-4V) described by ASTM Standard F136 or ISO 5832-3. The purpose of this submission is to add components to the existing system and to incorporate some minor design changes. The VERTE-SPAN™ Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability.
This document describes a medical device, the VERTE-SPAN™ Spinal System, and its substantial equivalence to an existing device. It is a 510(k) summary, which focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Therefore, the provided text does not contain information about acceptance criteria, device performance, clinical study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment in the context of device performance or AI/software validation.
This type of submission to the FDA, a 510(k), primarily relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or if there are differences, that those differences do not raise new questions of safety or effectiveness. Performance data, if present, would likely be limited to bench testing confirming material properties and mechanical integrity, rather than clinical efficacy studies in the way you've described for algorithmic performance.
In summary, none of the requested information about acceptance criteria or a study proving device performance (as you've defined it for AI/software) can be extracted from the provided text. The document is a regulatory submission focused on substantial equivalence, not a performance study report.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.