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The COOLIEF* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADVANCED) or the COOLIEF* Radiofrequency Generator (CRG-Advanced) to create lesions in nervous tissue. The device includes a fluid delivery system for commonly used fluid agents limited to contrast medium, saline, and/or anesthetic solution delivery at the target site. This device is also indicated for creating radiofrequency lesions of the genicular nerves for the management of moderate to severe knee pain of more than 6 months with conservative therapy, including medication, in patients with radiologically-confirmed ostecarthritis (grade 2-4) and a positive response (≥50% reduction in pain) to a diagnostic genicular nerve block.

The COOLIEF® SINERGY* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADV ANCED) or the COOLIEF* Radiofrequency Generator (CRG-ADVAN CED) to create RF lesions in nervous tissue. The device includes a fluid delivery system for commonly used fluid agents limited to contrast medium, saline, and/or anesthetic solution delivery at the target site.

The COOLIEF* Cooled Radiofrequency Kit Advanced is a modification to the predicate COOLIEF* Cooled Radiofrequency Kit cleared under K163461. The subject device consists of the following:

• COOLIEF* Cooled Radiofrequency Probe Advanced
• COOLIEF* Cooled Radiofrequency Fluid Tubing Kit ●
• COOLIEF* Cooled Radiofrequency Fluid Delivery Introducer ●

The modifications to the subject device are specific to the probe and fluid tubing kit.

The subject probe and fluid tubing kit are also included in the COOLIEFSINERGY Cooled Radiofrequency Kit Advanced.

The subject device has several configurations based on the anatomic region of use, length of the introducer and probe, and the length of the active electrode. The COOLIEF* Cooled Radiofrequency Kit Advanced is composed of fluid delivery introducers, probes, and fluid tubing kit. The kit is sterile, non-pyrogenic, and single-use. The COOLIEF* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADVANCED) or the COOLIEF* Radiofrequency Generator (CRG-Advanced) to create lesions in nervous tissue.

The COOLIEF* SINERGY* Cooled Radiofrequency Kit Advanced is to be used in conjunction with the Radiofrequency (RF) Pain Management Generator (PMG-ADVANCED) or the COOLIEF* Radiofrequency Generator (CRG-ADVANCED) to create RF lesions in nervous tissue. This device includes the same components as the COOLIEF* Cooled RF Kit Advanced, but also includes an Epsilon The Epsilon Ruler is a circular stainless-steel ruler that may be used during the COOLIEF Ruler. SINERGY* procedure to assist the user in providing a 'template' around the foramen, which is specific to performing procedure around the sacroiliac (SI) nerve.

This document is a 510(k) summary for the COOLIEF® Cooled Radiofrequency Kit Advanced, a medical device for creating lesions in nervous tissue. It details the device's characteristics, comparison to predicate devices, and non-clinical testing results.

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

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states that clinical data was not applicable for the subject device and therefore was not provided. All testing mentioned is "non-clinical testing" or "bench performance testing." The sample sizes for these non-clinical tests are not specified in the provided text, nor is the provenance of the data beyond being "bench performance testing."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as there was no clinical study described that involved establishing a ground truth with experts. The stated tests are non-clinical, focusing on device performance and safety parameters.

4. Adjudication Method for the Test Set

This information is not applicable as there was no clinical study described. Adjudication methods are typically relevant for human-led assessments in clinical trials.

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

This information is not applicable. The device described is a radiofrequency kit, not an AI-powered diagnostic or assistive tool for human readers. There is no mention of AI or MRMC studies in the provided text.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is hardware (a radiofrequency kit) and not an algorithm.

7. The Type of Ground Truth Used

This information is not applicable as no clinical studies with a ground truth were conducted or described. The "ground truth" for the non-clinical tests would be the established engineering and safety standards and specifications to which the device was tested.

8. The Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As stated above, the device does not involve a training set or ground truth in the context of an algorithm.

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The DIROS OWL™ URF-3AP(ML) SYSTEM is intended for the following:

1. Lesioning nerve tissue for functional neurosurgical procedures such as thalamotomies, pallidotomies, tractomies, and myelotomies; or
2. radiofrequency heat lesion procedures for the relief of pain
   The MLA-4 Multi-Lesion adaptor is not intended for use in brain surgery.

The Diros OWL™ radiofrequency generator URF-3AP(ML) is used by qualified medical personnel to make heat ablative lesions in central or peripheral nerve tissue for the treatment of movement disorders or for the relief of pain. The lesions are ablative in order to be therapeutic; i.e. the destruction of a small portion of the thalamus within the brain interferes with the motor pathway causing the tremor of Parkinson's disease, thereby relieving the tremor; or the destruction of the facet joint nerves in the lumbar vertebrae to block pain transmission by these nerves and thereby relieve certain types of low back pain.
The URF-3AP(ML) supplies up to 50 Watts of Radio Frequency energy at 481kHz under power or temperature control while continuously monitoring and displaying actual power delivered, measured probe temperature, time of power duration, and measured impedance. This 50W RF source can be directed to one of four channels, one at a time, to create simultaneously up to four lesions.
When used with monopolar probes, the system also delivers low-frequency stimulus pulses in either voltage or current controlled modes.

The provided text from the 510(k) submission for the DIROS OWL™ RF LESION GENERATOR MODEL URF-3AP WITH MULTI-LESION ADAPTOR (MLA-4) does not contain the specific information required to complete a table of acceptance criteria and reported device performance related to diagnostic accuracy, sensitivity, or specificity, nor does it detail a study that proves the device meets such criteria in the way a diagnostic AI device submission would.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a radiofrequency lesion generator, which is a therapeutic device. The performance testing outlined here is primarily centered on safety, electrical, mechanical, and EMC standards, and ensuring the device performs its intended function (generating RF energy, monitoring temperature, impedance, etc.) safely and effectively, rather than on diagnostic accuracy metrics.

Therefore, many of the requested fields cannot be populated based on the provided text.

Here's an attempt to answer what is possible, and clearly indicate what information is not available within the provided text:

Acceptance Criteria and Device Performance

Study Details (Based on available information)

1. Sample size used for the test set and the data provenance:

   • Not Applicable / Not Provided. The document describes performance testing for a therapeutic device (RF Lesion Generator) focused on safety and functional performance, not diagnostic accuracy. Therefore, there isn't a "test set" in the sense of a dataset of patient images or clinical cases for evaluation of diagnostic performance. The testing involved electrical, mechanical, and software verification as per medical device standards.

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

   • Not Applicable / Not Provided. As this is not a diagnostic device undergoing a diagnostic performance study, there's no concept of "ground truth" derived from expert consensus on medical images or patient outcomes in the context of this 510(k) submission.

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

   • Not Applicable / Not Provided. There was no "test set" requiring adjudication in the context of diagnostic performance evaluation.

4. 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 / Not Performed. This device is an RF lesion generator, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant and was not conducted.

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

   • Not Applicable / Not Performed. This is not an algorithm-based diagnostic device. Performance testing focused on the device's hardware and software functionality in isolation (standalone electrical, mechanical, software testing).

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

   • Not Applicable / Not Provided in the context of diagnostic "ground truth." The "ground truth" for this device's performance would be derived from instrumental measurements (e.g., power output, temperature readings, impedance values) against known calibrated standards, and successful completion of predefined engineering and safety tests according to international and national standards.

7. The sample size for the training set:

   • Not Applicable / Not Provided. This is not an AI/ML device that requires training data.

8. How the ground truth for the training set was established:

   • Not Applicable / Not Provided. This is not an AI/ML device.

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