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The Addivation Medical Cervical Interbody System is indicated for use in cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels from the C2 to T1 disc.

DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have six weeks of non-operative therapy.

The Addivation Medical Cervical Interbody System is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or cortico-cancellous bone graft, and is to be implanted via an open, anterior approach.

The Addivation Medical Cervical Interbody System is intended to be used with supplemental spinal fixation systems that have been cleared for use in the cervical spine.

The Addivation Medical Cervical Interbody System is a series of hollow, titanium interbody fusion cages intended for use in the cervical spine. The cage consists of an open window for bone graft containment and has serrations on the superior and inferior surfaces of the cage for fixation. The cage is offered in a variety of footprints, heights, and lordotic angles to adapt to varying patient anatomies. The Addivation Medical Cervical Interbody System implants are simultaneously built using Electron Beam Melting (EBM) method of additive manufacturing. Addivation Medical Cervical Interbody System Implants are provided sterile.

This document describes the marketing authorization for the Addivation Medical Cervical Interbody System. It is a cervical interbody fusion device intended for use in patients with degenerative disc disease.

Here's an analysis of the provided text in relation to acceptance criteria and study data:

1. Table of acceptance criteria and reported device performance:

   Acceptance Criterion (Type of Test)	Reported Device Performance
   Static and dynamic compression per ASTM F2077	"meets or exceeds the performance of the predicate devices"
   Static and dynamic torsion per ASTM F2077	"meets or exceeds the performance of the predicate devices"
   Subsidence testing per ASTM F2267	"meets or exceeds the performance of the predicate devices"

2. Sample size used for the test set and data provenance:
   The document does not specify sample sizes for the testing. It mentions that "Non-clinical testing was performed." These are in-vitro mechanical tests, not clinical studies with human data. Therefore, the concept of country of origin or retrospective/prospective data provenance does not apply in the typical sense for a clinical study.

3. Number of experts used to establish the ground truth for the test set and their qualifications:
   This question is not applicable. The device's performance was evaluated through laboratory mechanical testing based on established ASTM standards, not through expert review of clinical data to establish ground truth.

4. Adjudication method for the test set:
   Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review in clinical studies. This document describes mechanical testing.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
   Not applicable. This device is a physical interbody fusion system, not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study or AI assistance evaluation was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used:
   For the mechanical performance tests, the "ground truth" is defined by the requirements and thresholds established by the referenced ASTM standards (F2077, F2267) and the performance characteristics of the predicate devices. The device had to demonstrate comparable or superior mechanical properties under these controlled laboratory conditions.

8. The sample size for the training set:
   Not applicable. This is a physical medical device, not a machine learning algorithm. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established:
   Not applicable, as there is no training set for a physical implant.

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