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The Genesys Spine Apache™ Lateral Lumbar Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The intent of this Special 510(k) is to add new components to the currently cleared Genesys Spine Apache® Lateral Lumbar Interbody Fusion System (K130913). This submission will offer various device configurations based on surgical approach and patient anatomy, and consist of a Genesys Spine Lumbar Interbody Fusion Device, which may be implanted as a single device via a lateral approach.

The Genesys Spine Apache® Lateral Lumbar Interbody Fusion System is comprised of various device configurations designed to accommodate patient anatomy and provide the surgeon with different surgical approach options.

The Genesys Spine Apache® Lateral Lumbar Interbody Fusion System implant components are made of polyetheretherketone (Invibio PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. The additional implant offering being proposed has similar technological characteristics and identical indications as the currently cleared product line.

This document describes a medical device submission (K161404) for the "Genesys Spine Apache® Lateral Lumbar Interbody Fusion System," which is a Spinal Intervertebral Body Fusion Device.

The provided text does not contain information about a study proving the device meets acceptance criteria related to an AI/ML-driven medical device. Instead, it is a 510(k) summary for a physical medical implant. The performance data presented focuses on mechanical and engineering analyses (cross-sectional area analysis, Finite Element Analysis (FEA), and projected area calculations) to demonstrate substantial equivalence to existing predicate devices, rather than clinical performance or user studies for a diagnostic or AI-assisted system.

Therefore, I cannot provide the requested information about acceptance criteria, human reader studies, or ground truth establishment relevant to an AI/ML device. The document explicitly states that "The overall technology characteristics and mechanical performance data lead to the conclusion that Genesys Spine Apache® Lateral Lumbar Interbody Fusion System is substantially equivalent to [predicate devices]."

To answer your prompt with the information provided, I would have to state that the document does not contain the type of study and data you are asking for.

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