(91 days)
The 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 VBR Spinal System is also indicated for treating fractures of the thoracic and lumbar spine.
The 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 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, and Profile).
Additional components in various sizes and footprints.
The VBR Spinal System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.
The provided text describes a 510(k) summary for the VBR Spinal System, a medical device. This document focuses on establishing substantial equivalence to predicate devices and detailing the device's indications for use and materials.
However, based on the content provided, there is no information available regarding acceptance criteria, performance data, or a specific study proving the device meets acceptance criteria in the format requested. The document explicitly states:
"PERFORMANCE DATA: Performance data were submitted to characterize the additional components of the VBR Spinal System."
This statement confirms that performance data were submitted but does not present that data, nor does it define acceptance criteria or detail a study design.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details. This information is typically found in a separate performance study report or a more detailed section of the 510(k) submission that is not included in the provided text.
§ 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.