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The Minta Ryan RF Thermocouple Electrodes are used in conjunction with the commercially available Neurotherm (K011387), RF Lesion Generators and Pajunk RF disposable cannula (K060397) to create radiofrequency (RF) lesioning of peripheral nerve tissue. The Minta Ryan RF Thermocouple Electrode is a temperature sensor (thermocouple) which is used to deliver RF energy to the tissue. The RF energy is then transferred from the electrode which heats the surrounding tissue to create a lesion. The thermocouple also measures the temperature at the tip of the electrode. The Minta Ryan RF Thermocouple Electrodes are provided as non-sterile re-usable devices (re-processed single use). The Minta Ryan RF Thermocouple Electrode will be available in a variety of lengths and gauges. The Minta Ryan RF Thermocouple Electrode consists of a stainless steel shaft, a PET (polyethylene terephthalate) hub; a non-latex silicone rubber insulated electrical lead and a plug connector.

AI/ML Overview

The provided document is a 510(k) summary for the Minta Ryan RF Thermocouple Electrode. It states that this device is the same device that was previously cleared under K011387, with only a name change. Therefore, the acceptance criteria and the study that proves the device meets them refer to the original submission, K011387, and not to a new study conducted for K090608.

Based on the provided text, here's a breakdown of the requested information:

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

The document does not explicitly state acceptance criteria in a table format with specific quantitative targets. Instead, it refers to the performance established with the predicate device (K011387). The core claim is that the device is the predicate device.

Acceptance Criteria (Implied from predicate device)	Reported Device Performance (as the same device)
Functional performance characteristics of a Radiofrequency Lesion Probe for lesioning peripheral nerve tissue.	"Testing was performed to validate the functional performance of the Minta Ryan RF Thermocouple Electrode. In particular, specific performance and compatibility testing was performed with the Neurotherm RF Lesion Generators to show that the performance was met."
Compatibility with predicate RF Lesion Generators (Neurotherm K011387) and disposable cannulas (Pajunk K060397).	"The Minta Ryan RF Thermocouple Electrodes are used in conjunction with the commercially available Neurotherm (K011387), RF Lesion Generators and Pajunk RF disposable cannula (K060397) to create radiofrequency (RF) lesioning of peripheral nerve tissue." Also, "specific performance and compatibility testing was performed with the Neurotherm RF Lesion Generators to show that the performance was met."
Safety and effectiveness for its intended application.	"The Minta Ryan RF Thermocouple Electrodes are safe and effective for the application for which they are intended and have been tested to confirm their safety and effectiveness in this format for over 15 years, without incident in their UK and other countries, plus the USA since 2001."
Re-processability for steam sterilization.	"Additional steam sterilisation validation studies were carried out in February 2010 to validate each of the recommended sterilisation processes."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states that "All non-clinical data for the Minta Ryan RF Thermocouple Electrode was submitted under K011387 to confirm the performance characteristics." It also mentions "functional performance testing" and "compatibility testing" but does not specify the sample size or data provenance beyond asserting the device's long-standing use in the UK, other countries, and the USA since 2001. No specific test set sample size is provided for K090608, as the justification relies on the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document does not describe a study involving expert review for establishing ground truth, as it is a submission for a non-clinical device based on equivalence to a predicate. The testing mentioned is for functional performance and compatibility, not diagnostic accuracy requiring expert interpretation.

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

No adjudication method is described, as the evaluation is based on non-clinical performance and compatibility testing, not diagnostic accuracy.

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

No MRMC study was done, as this device is a physical electrode, not a diagnostic AI or imaging system. Therefore, there's no mention of human reader improvement or AI assistance.

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

A standalone performance evaluation was implicitly done, as the document refers to "functional performance" and "compatibility testing" of the device itself. However, this is for a physical medical device, not an algorithm.

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

The "ground truth" for this device would be its demonstrated functional performance in generating radiofrequency lesions and its compatibility with specified RF generators and cannulas, established through engineering and performance testing. There's no mention of expert consensus, pathology, or outcomes data as "ground truth" for this type of device submission.

8. The sample size for the training set

This is not applicable. The device is a physical electrode, not a machine learning algorithm that requires a training set.

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

This is not applicable, as there is no training set mentioned for this device.

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