(294 days)
The Highgate Curved Rod System is intended for unilateral screw fixation of the anterolateral thoracolumbar spine from T6 to L5 in skeletally mature patients. The Highgate Curved Rod System is intended to provide stabilization of a spinal segment as an adjunct to spinal fusion. Indications for the use of this device include spondylolisthesis (Grades 1 and 2), spinal stenosis, pseudarthrosis, failed fusion or degenerative disc disease (DDD) defined as back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Highgate Curved Rod System is not intended for patients having severe spondylolisthesis (Grades 3 and 4), deformities or curvatures, tumor or trauma i.e. vertebral fracture.
The Highgate Curved Rod System is available in titanium alloy (Ti6Al4V, ASTM F136) and includes rods and screws. Screws are used to attach the rod to the thoracolumbar spine. Rods are offered in two curvatures and have circular openings accommodate the screws.
The provided text is a 510(k) summary for the Highgate Curved Rod System. It describes the device, its intended use, and states that substantial equivalence was demonstrated to a predicate device. It does not contain any information about acceptance criteria, specific study designs, sample sizes, ground truth establishment, or performance outcomes beyond a general statement of substantial equivalence.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them from the given text.
The document states:
"Documentation was provided which demonstrated the Highgate Medial Curved Rods to be substantially equivalent to the previously cleared Highgate Lateral Curved Rods. The substantial equivalence is based upon equivalence in indications/intended use, manufacturing methods, interconnection mechanism, basic design, materials and testing."
This indicates that the device was cleared based on a comparison to a predicate device, rather than a de novo study with specific performance acceptance criteria and a detailed clinical or performance study report. The "testing" mentioned is likely referring to non-clinical bench testing to demonstrate similar mechanical properties or biocompatibility to the predicate, not a study assessing diagnostic or clinical performance against defined acceptance criteria in the way you have outlined.
§ 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.