(41 days)
The AccuFit® Lateral Plate System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracolumbar (TI-LS) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiosy, scollosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery. The device is intended as a temporary fixation device until fusion is achieved.
The AccuFit® Lateral 2-Hole Plate consists of non-sterile, single use, titanium alloy (Ti-6AI-4V ELI per ASTM F136) rigid plates and screws of varying sizes. The plate attaches by means of screws to the lateral portion of the vertebral body. The AccuFit® Lateral 2-Hole Plate (Subject Device) will be implanted using the instruments cleared with the AccuFit® Lateral Plate System (K162211), however a new inserter and tray will be introduced to the system that is to be used with the AccuFit® Lateral 2-Hole Plate (Subject Device). The AccuFit® Lateral 2-Hole Plate is to be provided non-sterile. They require sterilization prior to use.
The provided text describes a medical device (AccuFit® Lateral 2-Hole Plate) and its 510(k) clearance by the FDA based on substantial equivalence to predicate devices. It does not present information related to the performance of an AI/ML-enabled device, nor does it detail a study involving human readers or expert ground truth establishment for a diagnostic algorithm.
Therefore, I cannot extract the information required in your request about acceptance criteria, device performance, sample sizes, ground truth establishment, or human reader studies. The document pertains to a physical spinal implant, not an AI-based diagnostic tool.
§ 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.