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The Eminent Spine Standalone ALIF Interbody Fusion 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 Eminent Spine Standalone ALIF Interbody Fusion System is a stand-alone interbody fusion device intended to be used with screws which accompany the spacers for fixation. Hyperlordotic implants (≥25 lordosis) are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I Spondvlolisthesis. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The device is designed for use with autograft and/or allogenic bone graft composed ofcancellous bone graft to facilitate fusion. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Standalone ALIF devices are inserted through an anterior lumbar approach and packed with autogenous bone graft to facilitate fusion. Serrations on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebral bodies to aid in expulsion resistance, while screws are inserted through the anterior face of the implant for bone fixation. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved.

The cages are made from medical grade polyetheretherketone (PEEK) per ASTM F2026 with tantalum per ASTM F560 pins, from titanium alloy Ti-6Al-4V ELI per ASTM F136, or from additively manufactured Ti-6Al-4V per ASTM F3001. The integrated fixation screws and screw anti-backout plate are manufactured from Ti-6A1-4V ELI per ASTM F136.

This document describes a medical device, the Eminent Spine Standalone ALIF Interbody Fusion System, and its substantial equivalence to predicate devices, based on mechanical testing. It does not describe an AI/ML powered medical device. Therefore, I cannot provide an answer that includes information that is not present in the original document, such as:

• Acceptance criteria table with reported device performance for an AI/ML system
• Sample size used for the test set and data provenance (for an AI/ML system)
• Number of experts used to establish ground truth and their qualifications (for an AI/ML system)
• Adjudication method (for an AI/ML system)
• Multi-reader multi-case (MRMC) comparative effectiveness study information
• Standalone performance (algorithm only) for an AI/ML system
• Type of ground truth used (for an AI/ML system)
• Sample size for the training set (for an AI/ML system)
• How ground truth for the training set was established (for an AI/ML system)

The provided text focuses on the physical and mechanical characteristics of an interbody fusion device, not on the performance of an AI/ML algorithm.

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