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The Amendia Cervical Interbody Fusion Devices are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level or two contiguous levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. The Amendia Cervical Interbody Fusion Devices are used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone and supplemental fixation. Patients should have at least six (6) weeks of nonoperative treatment prior to treatment with an intervertebral cage.

The Amendia Lumbar Interbody Fusion Devices are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radios. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. Amendia Lumbar Interbody Fusion Devices are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.

The Amendia Interbody Fusion Devices consist of multiple components comprised of nonsterile, single-use implants fabricated from Invibio PEEK-Optima® LT1 or Solvay Advanced Polymers Zeniva™ ZA-500 PEEK (ASTM F2026) with tantalum (ASTM F560) x-ray markers, or Titanium alloy (Ti6Al4V ELI, ASTM F136). The Amendia Interbody Fusion Devices are used to provide structural stability and maintain disc space distraction in skeletally mature adults requiring intervertebral body fusion. They are designed to be used in conjunction with supplemental spinal fixation instrumentation.

The Amendia Interbody Fusion Devices are comprised of implants designed to treat the cervical and lumbar spine. The implants are available in a range of sizes and shapes to accommodate variations in surgical approach and patient anatomy. Each cage has a hollow center to allow placement of autograft. Ridges on the superior and inferior surfaces of the device help to grip the endplates and prevent expulsion.

The provided document is a 510(k) premarket notification for Amendia Interbody Fusion Devices, which are medical devices used in spinal fusion procedures. This type of regulatory document focuses on establishing substantial equivalence to existing legally marketed devices, rather than proving efficacy or meeting specific diagnostic performance criteria through clinical studies in the same way a diagnostic AI device would.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data specific to an AI/diagnostic device is not applicable to this document.

This document describes a medical device (surgical implants) and its intended use, material composition, and mechanical performance testing (engineering analysis and ASTM standards) to demonstrate equivalence to predicate devices, not the diagnostic performance of a software algorithm.

Here's a breakdown of why each requested point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document assesses substantial equivalence based on intended use, indications, material, and mechanical performance (engineering analysis, ASTM F2077, ASTM F1877), not diagnostic accuracy metrics like sensitivity or specificity.
2. Sample size used for the test set and the data provenance: Not applicable. There is no diagnostic "test set" in the context of an interbody fusion device. The document refers to "performance testing" based on engineering analysis and ASTM standards, which would involve physical specimens of the device, not a dataset of patient images or information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not relevant for an interbody fusion device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication is for resolving discrepancies in diagnostic interpretation, which is not relevant here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical implant, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for diagnostic accuracy is not relevant.
8. The sample size for the training set: Not applicable. There is no training set for a physical implant.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for a physical medical device (spinal implant) and does not contain the type of information requested about acceptance criteria and studies typical for AI/diagnostic software performance.

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