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The Spine Wave Anterior Cervical Spine System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have at least six (6) weeks of non-operative treatment. The Spine Wave Anterior Cervical Spine System is to be used with autogenous bone graft and placed via an open, anterior approach; supplemental fixation (i.e., posterior cervical screw fixation) is required to properly utilize this system.

The Spine Wave Anterior Cervical Spine (ACS) System consists of a selection of non-sterile, single use cervical interbody cages indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1.

The Spine Wave ACS cages are multi-component devices comprised of a cage body, anchor plate and graft cap. Spine Wave supplies the cage body and anchor plate as a paired combination, and the surgeon assembles the graft cap in situ. The Spine Wave ACS cages are offered in a variety of sizes and shapes to accommodate different patient anatomies and manufactured from titanium alloy (Ti-6Al-4V per ASTM F136), commercially pure titanium (ASTM F67) and PEEK-OPTIMA with 6% BaSO4.

Using the Spine Wave ACS Inserter, the surgeon places the cage body with undeployed anchor plate into the disc space. After placement, the surgeon uses the cage inserter to deploy the superior and inferior portions of the anchor plate into the adjacent vertebral bodies and pack the open end of the cage with autograft. Once grafting is complete, the surgeon snaps the graft cap into the open end of the cage.

The provided text describes a 510(k) premarket notification for a medical device, the "Spine Wave Anterior Cervical Spine System." It focuses on demonstrating substantial equivalence to predicate devices through various technical characteristics and performance testing. However, it does not contain information about an AI/algorithm-based device or a study involving acceptance criteria for such a device, human readers, or ground truth establishment relevant to AI performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI device meets these criteria based on the given text. The document is about a physical intervertebral body fusion device and its mechanical testing, not a diagnostic or AI-driven system.

To answer your request, I would need a document describing the development and validation of an AI/algorithm-based medical device.

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