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The Varian cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Varian cage is designed to be implanted bi-laterally via a posterior (PLIF) approach. The device is intended for use with supplemental fixation and is intended for use with autograft to facilitate fusion.

The Medyssey Varian cage is an interbody fusion device utilized to achieve fusion in the lumbosacral spine. The system is made of titanium alloy and includes seven sizes, ranging from 9 mm to 15 mm in height and 24 mm or 27mm in length with 8° or 10° lordotic angle versions.

The provided text describes a medical device, the "Varian cage," and its FDA 510(k) clearance, which attests to its substantial equivalence to previously marketed devices. However, the document does not describe a study that establishes acceptance criteria for performance metrics (such as sensitivity, specificity, or AUC) and then proves the device meets those criteria, as typically seen in AI/ML device submissions.

Instead, the "acceptance criteria" discussed are related to the mechanical and functional performance of the intervertebral body fusion device. The study described is a series of engineering tests designed to demonstrate the device's structural integrity and equivalence to predicate devices, not a study involving human readers or AI.

Therefore, many of the requested fields cannot be filled as they pertain to clinical or AI performance studies that are not present in this document.

Here's the breakdown of what can be extracted:

Acceptance Criteria and Device Performance (Mechanical/Functional)

1. A table of acceptance criteria and the reported device performance
(See table above)
The document states that testing was performed in accordance with ASTM F2077 and ASTM F2267, which are standards for intervertebral body fusion device testing. The acceptance criterion is implicitly meeting the requirements of these standards and demonstrating substantial equivalence to predicate devices in these mechanical performance aspects. The reported device performance is that these studies were designed to address risks and demonstrate substantial equivalent performance to predicate devices. Specific numerical results are not provided in this 510(k) summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document describes mechanical testing of a physical device, not a study with a "test set" of clinical data. The "samples" would be the physical devices tested according to the ASTM standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This document describes mechanical testing of a physical device. Ground truth is not established by experts in a clinical context for this type of submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document describes mechanical testing of a physical device. Adjudication methods are 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
No, an MRMC comparative effectiveness study was not done. This device is a physical intervertebral cage, not an AI/ML diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This device is a physical intervertebral cage, not an AI/ML algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. For mechanical testing, the "ground truth" relates to the physical properties and performance characteristics of the material and device design as per engineering standards, not clinical ground truth like pathology or expert consensus.

8. The sample size for the training set
Not applicable. This document describes mechanical testing, not a machine learning study with a training set.

9. How the ground truth for the training set was established
Not applicable. This document describes mechanical testing, not a machine learning study.

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