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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 HALYARD* COOLIEF* Cooled Radiofrequency Kit, in combination with the HALYARD* Radiofrequency (RF) Generator (PMG-BASIC/PMG-ADVANCED) (formerly Baylis Pain Management Generator or KIMBERLY-CLARK® Pain Management Generator) is intended for the creation of Radio-Frequency (RF) heat lesions in nervous tissue for the relief of pain, and 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 (RF) Kit is similar in construction, materials, energy source, and intended use to the predicate TransDiscal Cooled Radiofrequency Kit, which is a part of the cleared TransDiscal System (K062937) that also includes a "Y connector cable for the probes, a cooling pump, and a pump connector cable that connects to the RF generator. The COOLIEF* Cooled RF Kit includes fluid delivery introducers, cooled probes, and a burette tubing assembly. The subject COOLIEF* Cooled Radiofrequency Kit is available in several configurations based on the anatomic region of use (i.e., available in various introducer and probe lengths, and active tip lengths). The kit is sterilized to a SAL of 10-6 by EO terminal sterilization. The Fluid Delivery Introducer is a sterile, non-pyrogenic single-use cannula with a fluid delivery port. It is used with cooled radiofrequency probes in conjunction with the Halyard Radiofrequency Pain Management Generator, with cooling pump, to create lesions in nervous tissue for the relief of pain.

This document is a 510(k) Pre-Market Notification for the HALYARD* COOLIEF* Cooled Radiofrequency Kit, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the new device meets specific acceptance criteria in the way a clinical trial or algorithm validation study would.

The information provided describes the device, its intended use, and comparisons to a predicate device (TransDiscal Cooled RF Kit, K062937) and a reference device (Diros OWL Sterile Single-Use Trident R.F. Insulated Cannula models DTR and DTRH, K150371). The "acceptance criteria" here are implicitly the standards and features of the predicate device and the relevant biocompatibility and mechanical test standards.

Here's an analysis of the provided text in the context of your request:

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

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical sense of numerical thresholds for clinical efficacy or diagnostic accuracy. Instead, it demonstrates substantial equivalence through comparisons of technological characteristics, materials, and a series of non-clinical performance tests against established standards and the predicate device.

The "acceptance criteria" can be inferred as:

• Compliance with ISO standards for biocompatibility, sterility, mechanical properties, and electrical safety.
• Similar performance to the predicate device in terms of RF lesion creation, if not explicitly quantified.
• Functionality of the new fluid delivery system (side port with extension tubing).

Here’s a summary table based on the provided "Summary of Non-Clinical Testing (Performance Testing)" and "Biocompatibility Testing":

The "study that proves the device meets the acceptance criteria" is the collection of non-clinical tests summarized, demonstrating compliance with various ISO standards and equivalence in performance to the predicate and reference devices.

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 primarily describes non-clinical (bench) testing. For such tests, "sample size" refers to the number of units tested for mechanical properties, biocompatibility, etc. This specific numerical sample size is not explicitly provided in the summary for individual tests (e.g., how many cannulas were tested for bond strength). The data provenance is from internal testing conducted by the manufacturer (Halyard Health, Inc.), implicitly in the USA. These are prospective tests conducted on the newly designed device components.

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)

This section is not applicable. The "ground truth" concept is typically relevant for diagnostic or AI-based devices where human expert interpretation is compared to device output. For a physical medical device like a radiofrequency kit, performance is evaluated against engineering specifications, material standards, and functional tests, not against expert-established ground truth in a clinical sense.

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

This section is not applicable for the reasons stated above (non-clinical testing of a physical device).

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 section is not applicable. An MRMC study is relevant for diagnostic imaging devices or AI tools involving human interpretation. This submission is for a therapeutic radiofrequency ablation kit.

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

This section is not applicable. This is not an AI algorithm. The device performance is the physical device's ability to create lesions and deliver fluids, which is tested directly.

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

As mentioned, true "ground truth" as typically defined for AI or diagnostic devices is not applicable. The "ground truth" for this device's performance validation is its adherence to:

• Established ISO standards for biocompatibility and mechanical properties.
• Functional requirements (e.g., fluid flow, lesion size in a tissue model).
• Equivalence to the predicate device's known performance.

8. The sample size for the training set

This section is not applicable. There is no "training set" as this is not an AI/machine learning device. The device is validated through engineering and bench testing, not through training on data.

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

This section is not applicable for the reasons stated above.

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