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The Conway-Stuart Medical Model C4 RF Generator, in combination with Conway Stuart Medical electrodes, is indicated for coagulation of tissue. This device is intended for use by qualified medical personnel, trained in the use of electrosurgery.

Model C4 Radiofrequency Electrosurgical Generator

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a Model C4 Radiofrequency Electrosurgical Generator. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory information and indications for use.

It does not include:

1. A table of acceptance criteria and reported device performance.
2. Information on sample sizes, data provenance, or details about test sets.
3. The number or qualifications of experts used for ground truth.
4. Adjudication methods.
5. Details about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
6. Information about standalone algorithm performance.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. The sample size for the training set or how its ground truth was established.

Therefore, I cannot fulfill your request based on the provided input.

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