(21 days)
The Concorde VBR Spinal System is indicated for use in the thoracolumbar spine (i.e., T1-L5) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The Concorde VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine.
The Concorde VBR Spinal System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
The Concorde VBR Spinal System is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the VBR Spinal System include DePuy Spine titanium plate or rod systems (i.e., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, MONARCH, Expedium. Viper, and Profile).
Additional components in various sizes and footprints alternative minimally invasive surgical and an approach. The Concorde VBR Spinal System also contains Class 1 manual surqical instruments and cases that are considered exempt from premarket notification.
This document is a 510(k) summary for the Concorde VBR Spinal System. It describes the device, its intended use, and indicates that performance data were submitted. However, it does not detail specific acceptance criteria or the study data proving the device meets those criteria.
Therefore, I cannot provide the requested information about acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details from the provided text.
The relevant section simply states:
PERFORMANCE DATA:
"Performance data were submitted to characterize the additional components of the Concorde VBR Spinal System."
To answer your request, more detailed performance data and study reports would be needed than what is available in this 510(k) summary.
§ 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.