(153 days)
The CoreLink ZOUTM Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterior lateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels.
The CoreLink ZOU™ Anterior Lumbar Plate System is designed to provide temporary stability until fixation is achieved. It is intended for anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
The Zou® Anterior Lumbar Plate System is comprised of an assortment of titanium alloy plates and screws that act to stabilize the spine during the intervertebral fusion process. The Zou® Anterior Lumbar Plate System is manufactured from Ti-6A1-4V ELI in accordance with ASTM F136.
This is a 510(k) summary for a spinal fixation device, not a report about an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and human reader performance with AI assistance is not applicable and cannot be extracted from the provided text.
The document discusses the substantial equivalence of the Zou® Anterior Lumbar Plate System to previously cleared predicate devices based on:
- Indications For Use: Identical to predicate devices.
- Design, Function, and Materials used: Similar to predicate devices.
- Performance Standards: The device underwent testing based on a modified ASTM F1717 protocol, which included static compression bending, static torsion, and dynamic compression bending. The conclusion is that all substantial equivalence requirements were met.
There is no mention of an algorithm or AI being used, nor any studies involving human readers or ground truth for diagnostic purposes.
§ 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.