(625 days)
- The Levante Intervertebral Pillar prosthesis is intended for use in the thoracolumbar spine (i.e., T1 to L5) to replace and to restore the height of a diseased vertebral body resected or excised for the treatment of tumor as well as to concomitantly facilitate anterior decompression of the spinal cord and neural tissues. Two contiguous vertebral bodies are the maximum number of bodies the device is intended to replace. The device is intended to be always implanted with adjunctive fixation.
- To replace a vertebral body for tumor and to replace or restore the height of a vertebral body due to fracture; for example, burst or compression fractures
- To facilitate anterior decompression of the spinal cord and neural structure
- To facilitate the reduction of kyphotic deformities
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "Levante Intervertebral Pillar." It approves the device for marketing based on its substantial equivalence to previously marketed devices.
This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. The clearance letter is a regulatory approval, not a scientific study report. It states that the device is "substantially equivalent" to predicate devices for the indicated uses, but it doesn't detail the performance metrics or studies that would typically be described as "acceptance criteria" for a new, unproven technology.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications based on 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.