(133 days)
The Z-Span Plate System is intended to provide immobilization and stabilization as an adjunct to fusion in skeletally 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 intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the lumbar spine (L1-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 supplemental fixation device consisting of a variety of shapes and sizes of one-level lumbar and sacral plates and screws. The plates attach to the lumbar and lumbosacral spine (L1-S1). The implant components are made of titanium alloy per ASTM F-136 (Ti-6AL-4V ELi)
This is a 510(k) premarket notification for a spinal implant, not a medical device software. Therefore, the request for information on acceptance criteria and study proving device meets criteria is not applicable in the context of AI/ML software.
The document describes the Z-Span Plate System, a physical spinal fixation device.
Here's why the AI/ML specific questions are not relevant:
- No AI/ML Component: The submission focuses on mechanical testing, materials, and design of a physical implant. There is no mention of any software component, AI, or machine learning.
- Performance Data: The performance data presented refers to mechanical testing (static and dynamic axial compression bending testing and static torsion testing) conducted in accordance with ASTM F1717, comparing the device to a predicate device. This is standard for orthopedic implants, not software.
- Ground Truth, Training/Test Sets, Experts: These concepts are specific to evaluating diagnostic or predictive AI/ML algorithms, where the algorithm's output is compared against a "ground truth" established by experts or other definitive methods. They do not apply to the mechanical performance evaluation of a spinal plate.
Therefore, I cannot provide answers to the requested questions as they are designed for AI/ML medical devices, and this document pertains to a physical orthopedic implant.
§ 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.