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Intended for use for lesioning of neural tissue and for pain management. It is indicated for use in the peripheral nervous system. The APEX 6 is to be used with LCCS electrodes and cannulae and Conmed Thermogard Dispersive Electrodes.

The RF Innovations APEX 6 is a desktop RF lesioning generator which is used for the lesioning of neural tissue. The APEX 6 is a multi-lesioning, 6 channel portable generator that can provide continuous or pulsed RF output at 460 kHz, and monopolar or dual electrode modes. The device includes sensory and motor stimulation functions to fine tune electrode placement for procedures. Based on performance testing the device is designed to connect to LCCS FDA cleared lesioning probes which are inserted into patients for lesioning of neural tissue during medical procedures. Device features include a touch screen monitor incorporating microprocessor and graphics display for user interface as well as self-diagnostics, calibration checks, and recordkeeping functions.

This document is a 510(k) summary for the APEX 6 Lesioning Generator. It outlines the device's characteristics, its intended use, and how it compares to a predicate device (NeuroTherm NT 2000 RF Lesioning Generator) to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the supporting study, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details:

The provided document describes bench testing to demonstrate the substantial equivalence of the APEX 6 to its predicate device, primarily focusing on physical performance characteristics and safety standards. There is no clinical study (human-in-the-loop or standalone AI performance) described for this device, as it is a medical device generator and not an AI/Software as a Medical Device (SaMD).

Here's an breakdown of the specific points requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance: (See table above)

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

   • Sample Size: The document does not specify exact sample sizes for the "Lesion size" or "Comparison of treatment times" tests. It refers to "minimal, typical, and maximum energy delivery" for lesion size and "worse case conditions" for treatment times, implying a set of controlled experimental conditions rather than a large clinical "test set" in the common AI/SaMD sense. For "Every unit functional test," the sample size is "Every unit manufactured."
   • Data Provenance: The tests are described as "Bench testing," indicating they were performed in a laboratory or controlled environment. There is no information regarding country of origin or whether it's retrospective or prospective, as it's not a clinical data study.

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

   • This information is not applicable to the type of testing described. The "ground truth" for a device like a radiofrequency lesion generator is based on physical measurements (e.g., lesion dimensions, electrical parameters, time) and established engineering/safety standards. It's not about expert interpretation of medical images or clinical outcomes that would require human expert consensus for ground truth.

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

   • This is not applicable. Adjudication methods are typically used in clinical studies where multiple human readers interpret data, and significant disagreements require a tie-breaking mechanism or consensus. The tests described are bench tests with objective physical measurements.

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, an MRMC study was not done. This type of study is relevant for AI/SaMD devices where the AI assists human readers in diagnostic or screening tasks. The APEX 6 is a physical medical device generator, not an AI software.

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

   • While the APEX 6 itself performs functions autonomously (e.g., generating RF energy), the "standalone" concept usually applies to AI algorithms whose performance is evaluated independently of human input. No such "algorithm-only" performance study is described here, as the device's function is the generation and control of RF energy, which is evaluated through bench tests against physical parameters and predicate device performance. Software functions were validated, but this is different from a standalone AI performance study.

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

   • The ground truth for the bench tests was based on physical measurements (e.g., linear dimensions in millimeters, time in seconds, electrical parameters like impedance, voltage, current, power) and compliance with established international and national standards (e.g., IEC 60601 series, ANSI/AAMI, CAN/CSA).
   • For "Lesion size" and "Comparison of treatment times," the "ground truth" was derived from the performance of the legally marketed predicate device, used as a benchmark for substantial equivalence.

8. The sample size for the training set:

   • This information is not applicable. The device is not an AI/machine learning model that requires a "training set" in the sense of data used to train a statistical or learning algorithm. Its design and validation rely on engineering principles, product specifications, and comparisons to predicate devices.

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

   • This information is not applicable, as there is no training set for an AI/ML model for this device.

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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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COOLIEF* Radiofrequency Generator (CRG) System is indicated for use to create lesions during neurological lesion procedures and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The CRG is to be used with only Avanos RF Probes and accessories, such as Avanos TransDiscal Probes, COOLIEF*/Standard RF Pain Management Probes, Cannulas, Introducers, and Fluid Delivery Introducers. Use of CRG System is limited to the indications cleared under these Avanos devices and accessories.

The COOLIEF* Radiofrequency Generator (CRG) System uses controlled radiofrequency energy to generate heat that is used to create lesions in neurological tissues or to coagulate and decompress disc material to treat symptomatic patients with contained herniated discs. The following components of the predicate Pain Management Generator-TD (K072478), which must be used together, have been modified and are the subject of this 510(k): a) COOLIEF* Radiofrequency Generator (CRG), b) COOLIEF* Quad Pump Unit (QPU), and c) COOLIEF* Therapy Cables.

The provided text describes the 510(k) premarket notification for the COOLIEF* Radiofrequency Generator (CRG) System. It lists general and technological characteristics of the device and compares them to a predicate device, along with non-clinical performance data.

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

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

The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., minimum accuracy percentages). Instead, it lists various performance tests conducted and their successful completion, implying that "Pass" is the acceptance criterion for each test.

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 discusses non-clinical testing (performance testing). For these tests, specific sample sizes are not explicitly stated. For example, "Therapy Cable Mechanical Testing" implies that multiple cables were tested, but the number is not provided. Similarly, for "Bench-Top Lesion Validation," the number of lesions or trials is not detailed.

No clinical data was used for this submission, therefore, none of the typical provenance information (country of origin, retrospective/prospective) applies.

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 as the submission relies on non-clinical performance data and engineering verification tests. The "ground truth" for these tests would be established by the expected technical specifications and standards (e.g., a flow rate of >18mL/min, successful completion of a software test protocol). It doesn't involve subjective expert review in the way medical image analysis or diagnostic decision-making would.

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

This section is not applicable as the submission focuses on non-clinical performance testing and engineering verification. Adjudication methods are typically used in clinical studies or studies involving expert interpretation where there might be disagreements on ground truth.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and is not applicable to this submission. The device is a radiofrequency generator, not an AI-powered diagnostic or assistive tool for human readers. No AI assistance or human reader performance is mentioned.

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

This section is not applicable. The device is a hardware system (radiofrequency generator, pump, cables) and is not an algorithm or AI product capable of standalone performance.

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

The ground truth for the non-clinical performance tests is based on engineering specifications, established standards (e.g., IEC 60601 series), and expected functional performance. For instance, for "Quad Pump Unit Flow-Rate Verification," the ground truth is whether the measured flow rate meets the specified >18mL/min. For "Software Verification and Validation," the ground truth is compliance with the software requirements and absence of critical bugs. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this type of submission.

8. The sample size for the training set

This section is not applicable. The submission describes a medical device (radiofrequency generator system), not a machine learning or AI model that requires a training set.

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

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

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