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The Spinal Fusion Cage System is an intervertebral body fusion devices intended for use to skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Spinal Fusion Cage System is indicated to be used with autologous bone graft to facilitate fusion and are intended to be used with supplemental fixation. The device is to be used in patients who have had six months of nonoperative treatment.

device intended for use as an intervertebral body fusion device in the lumbosacral region (L2-S1) of the spine. It is implanted using a posterior or transforaminal approach and is intended to be used singly or in pairs with supplemental fixation. The Spinal Fusion Cage System is single component devices used to restore height of disc and to facilitate lumbar intervertebral body fusion with maintaining physiological lordotic angulation of lumbar spine. To allow maximum preservation and ensure ample contact surfaces with bony endplate, a variety of shapes and sizes are available and each device made withh PEEK Polymer has tantalum (ASTM F560) markers for ease of visualization on radiographs. Vertical square teeth on the top and the bottom surface prevent subsidence of the cage into the vertebral body while they increase the anchoring and prevent slipping or expulsion. To make solid fusion of intervertebral body, hollow space in the implant allows autologous bone graft material to be filled. The implant has safety proven structure and material (Polyetheretherketone, ASTM F2026 & Titanium Ti6Al4V Eli ASTM F136) to promote biological synostosis and assures mechanical safety against load.

The provided text is a 510(k) Summary for a medical device (Spinal Fusion Cage System), not a study describing the acceptance criteria and performance of an AI-powered medical device.

This document details the regulatory submission for an intervertebral body fusion device, comparing it to predicate devices to establish substantial equivalence based on material, design, and mechanical performance. It does not contain information related to AI or a study proving an AI device meets acceptance criteria.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, ground truth methods, etc.) from the provided text as it is irrelevant to AI device evaluation.

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