(73 days)
The GEO Structure is indicated for use in the thoracolumbar spine (i.e., T1 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The GEO Structure is also indicated for treating fractures of the thoracic and lumbar spine. The GEO Structure 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 GEO Structure is a vertebral body replacement device manufactured from surgical implant grade titanium alloy as described by ASTM F-1108 (Ti 6Al 4V). The implant has a satin finish surface and is available in various shapes and sizes. The GEO Structure is provided either sterile or nonsterile.
The provided text is a 510(k) summary for the GEO Structure, a vertebral body replacement device. It primarily focuses on demonstrating substantial equivalence to a predicate device based on indications for use, intended use, materials, and biomechanical performance.
Crucially, this document does NOT contain information about specific acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
The document states: "Based on the same indications for use, intended use, similarity in materials of construction and equivalent biomechanical performance, the GEO Structure is considered substantially equivalent to the legally marketed predicate device." This indicates that the regulatory approval was based on demonstrating equivalence, not on a new clinical study with specific performance metrics against pre-defined acceptance criteria as would be the case for novel AI/software devices or those requiring new clinical evidence.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, study details, and performance metrics because that information is not present in the provided 510(k) summary. These summaries typically do not contain the detailed study results that would satisfy the prompt's requirements.
§ 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.