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Smith & Nephew RF Cannulae are intended to facilitate placement of Smith & Nephew RF Denervation Probes. The Smith & Nephew RF Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.

Smith & Nephew RF Cannulae are intended to facilitate the placement of Smith & Nephew RF Denervation Probes for the use in RF heat lesion procedures. The RF Cannulae are offered in a variety of lengths, gauges and tip configurations to accommodate various anatomical locations and differences in patient anatomy.

I am sorry, but the provided text, while being a 510(k) summary, does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The document is a submission for a medical device (Smith & Nephew RF Cannulae) for the purpose of demonstrating substantial equivalence to a previously cleared device (K063467). It focuses on:

• Device Description: What the cannulae are and their purpose.
• Intended Use: How they are meant to be used (facilitating placement of RF Denervation Probes for RF heat lesion procedures for pain relief).
• Technological Characteristics: Stating they are similar to the predicate device with minor improvements for insertion performance.
• Substantial Equivalence Information: Explicitly stating equivalence based on design, indications for use, and material composition to the predicate device.
• List of Models: Various gauges, lengths, and tip configurations.
• FDA Clearance Letter: Confirming the 510(k) clearance based on substantial equivalence.

There is no mention of any performance studies, clinical trials, or validation data that would include acceptance criteria or reported device performance metrics. The approval appears to be based on the similarity to an already cleared device, implying that the safety and effectiveness are established through that predicate.

Therefore, I cannot populate the requested table or answer the specific questions about studies, sample sizes, ground truth, or expert involvement as that information is not present in the provided text.

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