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When used as a cervical intervertebral fusion device, the K7C™ spacers are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine.

The K7C™ Spacer is a collection of radiolucent interbody devices having a keystone-shaped cross-section. The superior and inferior surfaces are open with parallel serrations to facilitate implant stability. The implants are available in an assortment of height, length, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements.

The provided text describes a medical device, the K7C™ Spacer, and its mechanical testing for a 510(k) submission. However, it does not contain the specific information requested about acceptance criteria for device performance in the format of a table, nor does it detail a clinical study with human subjects, ground truth establishment, or expert involvement as outlined in the request.

Therefore, many of the requested elements cannot be extracted directly from the provided text.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance:

The document states: "Mechanical testing of the worst case K7C™ spacer was performed according to ASTM F2077 and included static and dynamic compression and static and dynamic torsion. The subsidence properties were evaluated according to ASTM F2267. The mechanical test results demonstrate that the K7C™ Spacers perform as well as or better than the predicate devices."

This indicates that the acceptance criteria were likely defined by the performance of the predicate devices in these specific ASTM standards (ASTM F2077 and ASTM F2267). The reported device performance is stated as "perform as well as or better than the predicate devices."

2. Sample sized used for the test set and the data provenance:

The document mentions "mechanical testing of the worst case K7C™ spacer." This suggests a limited sample size, likely a few units chosen to represent the most challenging design. It does not provide an exact number. The data provenance is from mechanical testing, not human subjects, and is likely conducted in a laboratory setting (prospective testing of manufactured devices). No country of origin for this specific testing data is mentioned, but the sponsor is in Henderson, NV, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the study described is mechanical testing of a medical device, not a study involving human diagnosis or interpretation where expert ground truth would be established.

4. Adjudication method for the test set:

This information is not applicable for mechanical testing.

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:

This information is not applicable. The document describes mechanical testing of an intervertebral fusion device, not an AI-powered diagnostic tool requiring MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used:

For mechanical testing, the "ground truth" would be the objective physical measurements obtained according to the specified ASTM standards. These standards themselves establish the methodology for determining the performance characteristics.

8. The sample size for the training set:

This information is not applicable. There is no "training set" as this is mechanical testing of a physical device, not a machine learning model.

9. How the ground truth for the training set was established:

This information is not applicable as there is no training set mentioned or implied.

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