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The C7 Anterior Cervical Intervertebral Fusion Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. C7 Anterior Cervical Intervertebral Fusion Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach and packed with autogenous bone. C7 Anterior Cervical Intervertebral Fusion Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The Medyssey C7 Anterior Cervical Interbody Fusion Cage system consists of a series of PEEK (polyetheretherketone) cervical interbody spacers of various footprints and thicknesses. The C7 ACIF cages have ridges on their superior and inferior surfaces to prevent migration, and graft windows to allow for bony fusion. Tantalum markers are incorporated into the devices to allow for radiographic visualization of the implants.

The provided document is a 510(k) summary for the Medyssey C7 Anterior Cervical Interbody Fusion Cage. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing. It does not involve studies evaluating the diagnostic accuracy or performance of an AI/ML powered medical device, which would typically involve human readers, ground truth establishment, or training/test sets.

Therefore, many of the requested elements are not applicable to this document. The information provided below reflects what is available in the document.

1. Table of Acceptance Criteria and Reported Device Performance

• Static Compression
• Static Torsion
• Static Compressive Shear
• Dynamic Compression
• Subsidence
• Expulsion | Non-clinical tests were performed for:
• Static Compression
• Static Torsion
• Static Compressive Shear
• Dynamic Compression
• Subsidence
• Expulsion

Conclusion: Based on the testing and comparison analysis to the predicate devices, Medyssey believes that the subject Medyssey C7 Anterior Cervical Cage System is substantially equivalent to the predicate devices. The minor differences in design were evaluated through testing and do not affect the safety and efficacy of the device for its intended use. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a non-clinical testing submission for a physical medical device (interbody fusion cage), not an AI/ML powered device using test sets of data. The "tests" refer to mechanical and material property assessments.

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. Ground truth as typically understood for diagnostic AI/ML models is not relevant here. The "ground truth" for a physical device would relate to engineering standards and mechanical properties, assessed by engineers and technicians.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for human interpretation of data, typically in diagnostic studies.

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 an interbody fusion cage, not an AI-assisted diagnostic tool.

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

Not applicable. This device is an interbody fusion cage, not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. For this device, "ground truth" would be defined by engineering specifications and material science standards.

8. The sample size for the training set

Not applicable. This device is an interbody fusion cage, not an AI algorithm requiring a training set of data.

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

Not applicable.

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