(29 days)
The Valeo™ VBR is intended for vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable vertebral body or portion thereof, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.
The Valeo™ VBR 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 Valeo™ VBR is always to be used with supplemental internal spinal fixation. Additionally, the Valeo™ VBR may be used with bone graft.
The Valeo™ VBR acts as a spacer to maintain proper vertebral body spacing and angulation following partial or total corpectorny. The Valeo™ VBR is manufactured from MC4, a ceramic material. The Valeo™ VBR is for single level anterior spinal use from T1-L5.
The provided text is for a medical device 510(k) submission for the Amedica Valeo™ VBR. This specific document outlines the device's intended use and substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device.
The document describes a physical medical device (vertebral body replacement) and its regulatory classification. The "Performance Standards" section simply states that testing was performed and the device is substantially equivalent to predicate devices, but it does not detail any specific performance metrics or the studies conducted to establish them.
Therefore, for an AI/ML powered device, I cannot fill out the requested table regarding acceptance criteria and performance, nor can I provide information related to sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because these concepts are not applicable to the information provided in the K073125 document.
§ 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.