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The SC-C, RFK-DS and RFK-DB Radionics disposable RF Cannulae are insulated disposable cannulae designed for use with a Radionics Radiofrequency Lesion Generator to create heat lesions for relief of pain.

The SC-C cannulae are compatible with the commercially available Radionics SMK-TC thermocouple electrodes. They are used in the same way as the commercially available Radionics RSM-C and SMK-C cannulae. The RFK-DS and RFK-DB are compatible with the commercially available RFK-TC thermocouple electrode . They are used in the same way as the commercially available Radionics RSM-C and SMK-C cannulae.

AI/ML Overview

The provided text is a 510(k) premarket notification for Radionics Disposable RF Cannulae. For devices of this nature, the acceptance criteria are generally based on substantial equivalence to predicate devices. There are no direct performance metrics, such as sensitivity, specificity, or image quality, that are usually reported for such accessories. Instead, the "study" demonstrating that the device meets criteria is primarily a comparison of technological characteristics and intended use to previously cleared devices.

Here's the breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred from Substantial Equivalence to Predicate Devices)	Reported Device Performance (as described in the 510(k))
Intended Use Equivalence: Device must have the same intended use as predicate devices.	The SC-C, RFK-DS and RFK-DB are intended for use in radiofrequency (RF) heat lesion procedures for relief of pain. This is the same intended use as the RSM-C Cannula (K963577) and SMK-C Cannula (K870028).
Technological Characteristics Equivalence: Device must have similar design, materials, and operational principles as predicate devices.	The Radionics Disposable RF Cannula (SC-C, RFK-DS and RFK-DB) has similar technological characteristics as the commercially available Radionics RSM-C cannulae (K963577) and SMK-C cannulae (K870028). The insulating material is widely used as a medical grade heat shrinkable tubing.
Safety: Device must demonstrate safety comparable to predicate devices.	Labeling contains instructions for proper use, including a description, directions for use, and applicable safety information. "These instructions ensure safe and effective use of the device when followed by the physician."
Biocompatibility: Materials used must be biocompatible.	Biocompatibility has been performed on Radionics SC-C10 Cannula. (It's implied that this applies to the materials used in the new devices as well).
Compatibility: New cannulae should be compatible with existing equipment (e.g., electrodes, generators).	The SC-C cannulae are compatible with the commercially available Radionics SMK-TC thermocouple electrodes. The RFK-DS and RFK-DB are compatible with the commercially available RFK-TC thermocouple electrode. They are designed for use with a Radionics Radiofrequency Lesion Generator.

2. Sample size used for the test set and the data provenance

The document does not describe a test set, clinical study, or data provenance in the traditional sense of a clinical trial for device performance. The demonstration of safety and effectiveness for these accessories is based on a comparison to predicate devices, material biocompatibility, and intended use as an accessory to an existing procedure. There are no quantitative performance metrics (like accuracy, F1-score, etc.) typically associated with AI/diagnostic devices that would require a "test set."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As described above, there was no "test set" and no ground truth establishment by experts in the context of device performance as one might expect for a diagnostic or AI device. The expertise involved would be in the design, manufacturing, materials science, and regulatory interpretation to establish equivalence.

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

Not applicable. There was no test set or clinical data requiring adjudication.

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 a disposable cannula for radiofrequency heat lesion procedures, not an AI-assisted diagnostic or therapeutic device involving human readers.

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

Not applicable. This is a medical accessory, not an algorithm or AI system.

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

Not applicable in the context of performance metrics. The "ground truth" for this 510(k) submission is the existence and established safety and effectiveness of the predicate devices (RSM-C Cannula K963577 and SMK-C Cannula K870028). The new devices are deemed substantially equivalent to these already-cleared devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. There is no training set for this type of medical accessory.

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