(81 days)
X-PAC® N-GAGE™ 2-Hole and 4-Hole Lumbar Plate System is indicated for temporary stabilization during spinal fusion via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via a lateral or anterolateral surgical approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability in skeletally mature patients for the treatment of degenerative disc disease (DDD), spondylolisthesis, spondylolysis, spinal stenosis, pseudoarthrosis, deformity (defined as scoliosis, kyphosis, or lordosis), tumors, trauma (i.e. fractures including dislocation and subluxation), and/or failed previous fusion. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
N-GAGE™ 2-Hole and 4-Hole Plates may be assembled with the X-PAC® LLIF Expandable Cage to create a plate-spacer assembly. When assembled to the X-PAC® LLIF Expandable Cage, the plate-spacer assembly is indicated for standalone use at one or two levels of the lumbosacral spine (L2-S1), as an adjunct to fusion in skeletally mature patient with degenerative disc disease (DDD). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous bone graft and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have at least six (6) months of non-operative treatment.
N-GAGE™ 1-Hole Plate is to be assembled with the X-PAC® LLIF Expandable Cages. When assembled, the system is intended to maintain the relative position of X-PAC® LLIF Expandable Cage and intended for use with supplemental fixation (e.g., posterior spinal systems).
X-PAC® N-GAGE™ Lumbar Plate System is a lumbar plate system comprised of implants (plates and screws), couplers, and surgical instruments. The implants are used in a lateral approach interbody fusion and are designed to provide rigid stabilization and support to the spinal column. The plate helps to restrict movement between adjacent vertebrae, preventing further injury and promoting the fusion of the bones over time. During operation, the plate is positioned laterally or anterolaterally, following insertion of a spinal interbody fusion spacer, via a removable inserter and screwdriver. The plate system can be installed either attached to (with a coupler) or floating from the X-PAC® LLIF Cage. The plates are available in multiple sizes and configurations to accommodate all heights of interbody spacing. The plates have a flat, elongated shape that conforms to the curvature of the spine at the required level(s) and have holes to secure the plate to the vertebrae. The fully threaded screws are available in two diameters and multiple lengths to accommodate varying anatomies. The screws are inserted into the vertebral body to hold the plate in place. The system includes a 1-hole, 2-hole, and 4-hole configuration. The screw can be angled up to 20 degrees away from the cage, and 10 degrees towards the cage. Each screw hole has an adjacent tab, which is turned and locked over the screw head once the screw has been inserted. The coupler is used to create a secure connection between the plate and the interbody device. The plates, screws, tabs, and couplers are manufactured from medical grade titanium alloy per ASTM F136.
This document is a 510(k) clearance letter for a medical device called the X-PAC® N-GAGE™ Lumbar Plate System. It is not an AI/ML device, and therefore the request to describe acceptance criteria and associated studies for such a device is not applicable.
The document describes a physical medical implant (a lumbar plate system) and details the non-clinical mechanical tests performed to ensure its safety and effectiveness. It does not mention any artificial intelligence or machine learning components, nor does it refer to acceptance criteria that would typically be associated with AI/ML device performance (e.g., accuracy, sensitivity, specificity, AUC).
Therefore, I cannot provide the requested information regarding acceptance criteria and studies that prove an AI/ML device meets them, as the provided document does not pertain to an AI/ML 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.