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The Endoskeleton® TAS Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device may be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be use with autograft bone.

The Endoskeleton TAS is comprised of a variety of implant sizes to accommodate various patients' anatomy and pathology, and includes associated instrumentation. All implantable

This is a 510(k) summary for a spinal implant device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML algorithms, are not present in this document.

The document describes the device, its intended use, technological characteristics, and its substantial equivalence to predicate devices, which is the standard pathway for 510(k) clearance for conventional medical devices.

I cannot provide the requested information based on the input text because it describes a traditional medical device (intervertebral body fusion device), not an AI-powered diagnostic or predictive algorithm. There are no mentions of "acceptance criteria" for algorithm performance, "test sets," "training sets," "ground truth," "experts for ground truth," or "multi-reader multi-case studies" in the context of AI evaluation.

The "study that proves the device meets the acceptance criteria" in this context refers to the demonstration of substantial equivalence to legally marketed predicate devices, which typically involves comparing technological characteristics, intended use, and performance data (like mechanical testing, biocompatibility, etc.) relevant to the physical implant, rather than a clinical study evaluating diagnostic accuracy or AI performance.

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