(99 days)
The Affix IIS Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the lumbosacral spine (L1 - S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion in the following conditions:
· 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)
• Tumor
The Affix IIS Spinous Process Plate System is not intended for stand-alone use.
The Affix IIS Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the lumbosacral spine (L1-S1). It is intended for plate fixation/attachment to the spinous process for the purpose of achieving supplemental fusion, and is not intended for stand-alone use.
This document is a 510(k) summary for the NuVasive® Affix IIS® Spinous Process Plate System, a medical device. It does not describe an AI/ML powered device, nor does it contain information about acceptance criteria, efficacy studies, or performance metrics in the way a diagnostic or prognostic AI algorithm would.
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on:
- Indications for Use: The Affix IIS Spinous Process Plate System is a posterior, non-pedicle supplemental fixation device for use at a single level in the lumbosacral spine (L1-S1) to achieve supplemental fusion in conditions like Degenerative Disc Disease (DDD), Spondylolisthesis, Trauma, and Tumor. It is not for stand-alone use.
- Technological Characteristics: Comparison of design, labeling/intended use, material composition, and function to predicate devices.
- Performance Data: Nonclinical (bench) testing, including static and dynamic axial compression and static torsion, to demonstrate mechanical equivalence to predicates.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets those criteria, as it pertains to AI/ML device performance. This document is a regulatory submission for a physical medical implant, not a software-driven diagnostic or treatment planning system.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.