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The RSM-C is intended for use in radiofrequency (RF) heat lesion procedures for relief of pain. This is the same intended use as the SMK Cannula and TIC Cannula.

The RSM-C Radionics Sluijter-Mehta Cannulae are insulated disposable cannulae designed for use with a Radionics Radiofrequency Lesion Generator to create heat lesions for relief of pain. These cannulae are compatible with the commercially available Radionics SMK-TC thermocouple electrodes. They are used in the same way as the commercially available Radionics SMK-C Cannulae.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics. The document describes a medical device, the Radionics Sluijter-Mehta Cannula (RSM-C), and states its intended use and basis for substantial equivalence to predicate devices (SMK Cannula and TIC Cannula).

Specifically, the document focuses on:

• General Information: Trade name, model number, manufacturer, contact, classification, predicate devices, and intended use.
• Safety and Effectiveness Information: Stating that the labeling contains proper use and safety information, and that the device has similar intended use and technological characteristics to existing devices.

There is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for any test set.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Types of ground truth used.
• Sample size for training sets or how their ground truth was established.

Therefore, I cannot fulfill the request for this specific information based on the provided text.

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