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The Endoskeleton® TT IBD 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 must 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 used with autograft bone.

The Endoskeleton® TT IBD is comprised of a variety of implant sizes to accommodate various patient anatomy and pathology, and associated instrumentation. All implantable components are manufactured from medical grade titanium alloy (Ti6A14V-ELI),

While the provided document is a 510(k) summary for the Endoskeleton® TT IBD, it does not contain the type of detailed information typically found in an AI/Software as a Medical Device (SaMD) study for performance evaluation.

This document describes a medical device (an intervertebral fusion device) which is a physical implant, not an AI software. The "Performance Testing" mentioned refers to pre-clinical testing for the physical device's adequacy (likely mechanical, biocompatibility, etc.), not a clinical study involving human readers or AI algorithms as would be the case for a SaMD.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from this document. These types of details are specific to the evaluation of AI or software-based medical devices.

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