(55 days)
The Z-Span Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracolumbar spine (T1-L5) or via the anterior approach below the bifurcation of the great vessels in the treatment of the lumbar and lumbosacral spine (L1-S1).
The Z-Span Plate System is intended to provide immobilization as an adjunct to fusion in sketally mature patients in the treatment of the following:
- · Fracture (including dislocation and subluxation)
• Tumor
· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- · Pseudoarthrosis
- · Spondylolysis
- · Spondylolisthesis
- · Scoliosis
- · Lordotic deformities of the spine
- · Spinal stenosis
- · Failed previous spine surgery
The Z-Span Plate System is supplemental fixation device consisting of a variety of shapes and sizes of thoracic, lumbar, and sacral plates and screws. The plates attach to the thoracic, lumbar, and lumbosacral spine (L1-S1). The implant components are made of titanium alloy per ASTM F-136 (Ti-6AL-4V ELi).
This document is a 510(k) premarket notification for a medical device called the Z-Span Plate System. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.
However, the provided text does not contain information about acceptance criteria or a study proving that a software device meets acceptance criteria. Instead, it focuses on the Z-Span Plate System, which is an implantable orthopedic device for spinal fixation. The "Performance Data" section specifically mentions mechanical testing (static and dynamic axial compression bending testing and static torsion testing) according to ASTM F1717, which is relevant for the physical properties of surgical implants, not for the performance of a software algorithm.
Therefore, I cannot provide the requested information about acceptance criteria for a software device, its reported performance, sample sizes, ground truth establishment, or expert adjudication. The document pertains to a physical medical implant, not a software device.
§ 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.