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The M6-C™ Single Use, Disposable Instrumentation are intended for the placement and positioning of the M6-C Artificial Cervical Disc.

The M6-C™ Artificial Cervical Disc is an intervertebral disc prosthesis designed to permit motion of a functional spinal unit in the cervical spine when replacing a degenerated native disc (PMA P170036). The surgical implantation of the M6-C Cervical Artificial Disc requires specific surgical instruments including: a footprint template and a trial to determine the appropriate size and position of the implant; a fin cutter to create tracks in the superior and inferior vertebral endplates; and an implant inserter to place the artificial disc into the desired position to aid in and ensure correct placement within the intervertebral space. Additionally, these are general surgical instruments to assist in the distraction and mobilization of the disc space. The single use instruments are composed primarily of reinforced polyacrylamide (PAA+50%GF) with some structural components made from surgical stainless steel and are intended to be reusable.

The provided text focuses on the FDA's 510(k) clearance for the M6-C™ Single Use, Disposable Instrumentation. It details the device's intended use and design, emphasizing its equivalence to a predicate device. However, it does not contain information about acceptance criteria for an AI/ML device, details of diagnostic performance studies, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details (effect size, human improvement).
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document describes a surgical instrumentation device, not an AI/ML diagnostic device. The performance testing mentioned (Impact Testing, Bend/Functional Testing, Sterilization and Biocompatibility Testing) are typical for physical surgical instruments, not for evaluating AI model performance.

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