(59 days)
The NuVasive CoRoent System is a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
The NuVasive CoRoent System is an implantable PEEK vertebral body replacement device indicated for use in the thoracic and lumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues.
The device is available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.
The NuVasive CoRoent System is a partial vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of a collapsed, damaged, or unstable vertebral body(s) due to tumor or trauma and to achieve decompression of the spinal cord and neural tissues. The System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be used at the surgeon's discretion.
The provided text is a 510(k) summary for the NuVasive CoRoent System, a vertebral body replacement device. It does not describe acceptance criteria or a study proving that the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on design, materials, indications for use, and mechanical testing.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document explicitly states: "H. Summary of Clinical Tests (Not Applicable)." This indicates that no clinical studies were performed for this 510(k) submission to demonstrate the device meets specific performance criteria against a ground truth from human data. The assessment was based on non-clinical (mechanical) testing and comparison to predicate devices.
§ 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.