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The Ghost Spacer System is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.

The Ghost Spacer System consists of implants made of titanium alloy (Ti-6Al-4V ELI per ASTM F3001). The spacers have a basic rectangular shape, a hollow center for placement of autograft bone graft and/or allogeneic bone composed of cancellous and/or corticocancellous bone to help promote fusion and a smooth bullet shaped distal surface. They are available in an assortment of height, length and anteroposterior angulations to accommodate many different anatomic requirements. The implants are delivered via a posterior, transforaminal, lateral or anterior approach. The devices are manufactured using the Electron Beam Melting (EBM) additive manufacturing method. All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the GHOST Spacer System components with components from any other system or manufacturer. The GHOST Spacer System components should never be reused under any circumstances.

This document describes the FDA's 510(k) clearance for the Life Spine Ghost Spacer System, an intervertebral body fusion device. While it establishes the device's substantial equivalence to predicate devices, it does not include a study describing acceptance criteria and demonstrating the device meets those criteria from an AI/algorithm perspective.

The provided text focuses on the device's physical and functional characteristics, material, and mechanical testing (e.g., Static and Dynamic Axial Compression & Compressive Shear Testing per ASTM F2077, and Static subsidence testing per ASTM F2267) to demonstrate substantial equivalence to previously cleared devices.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment for an AI-powered device, as the information is not present in the provided document. The device in question is a physical implant, not an AI/algorithm-driven diagnostic or therapeutic tool.

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