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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.

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