(122 days)
The Relievant RFG is intended to be used with RF probes FDA cleared as part of the Relievant INTRACEPT Intraosseous Nerve Ablation System for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least six months of conservative care, and is also accompanied by either Type 1 or Type 2 Modic changes on an MRI.
The Relievant RFG is a universal AC powered, microcontrolled, bipolar RF generator intended to deliver RF energy to a targeted site. During RF energy delivery, power is continuously monitored and controlled, based on temperature and impedance measurements at the treatment site, to ensure proper operation. RF probes FDA cleared as part of the Relievant INTRACEPT Intraosseous Nerve Ablation System are used with the Relievant RFG.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Relievant Medsystems RF Generator:
The provided document describes the Relievant Medsystems RF Generator (RFG), a radiofrequency lesion generator. The acceptance criteria and testing detailed are primarily non-clinical performance tests aimed at demonstrating the device's substantial equivalence to a predicate device, rather than clinical efficacy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria / Standard | Reported Device Performance (Results) |
|---|---|---|
| Electrical Safety | IEC 60601-1-1 (General requirements for basic safety and essential performance) AND IEC 60601-2-2 (Particular requirements for high-frequency surgical equipment) | Pass. Complies with the standards. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 (Electromagnetic compatibility – Requirements and Tests) | Pass. Complies with the standard. |
| Temperature Accuracy | Verify output temperature 25°C-100°C ± 1.9°C | Pass |
| RF Output Power | IEC 60601-1-2 (Electromagnetic compatibility – Requirements and Tests) | Pass. Complies with the standard. |
| Mechanical Testing | IEC 60601-1-1, IEC 60601-2-2, and Relievant specified requirements | Pass. Complies with the standards and Relievant requirements. |
| Software | FDA's May 2005 “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Major Level of Concern) | Pass. Met FDA's Guidance requirements for software development documentation and testing. |
| Programmable Electrical Medical System (PEMS) | IEC 62304 Medical Device Software – Software Life-Cycle Processes | Pass. Complies with the standard. |
| Interface: Usability | FDA Guidance Document: "Applying Human Factors and Usability Engineering to Medical Devices", IEC 60601-1-6 (Usability), and IEC 62366-1 (Application of usability engineering) | Pass. Complies with the standards. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical performance testing, primarily bench testing and software validation. Therefore, there are:
- No "test set" in the traditional sense of patient data.
- No human "sample size" for these performance tests.
- The data provenance is laboratory testing of the device itself against established medical device standards and internal company requirements.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since the testing described is non-clinical (electrical, mechanical, software, etc.), the "ground truth" is established by adherence to recognized medical device standards and internal specifications. This means:
- No external human experts were used to establish a "ground truth" for a patient-based test set.
- The "ground truth" is derived from engineering specifications and regulatory standards. Presumably, internal engineers and quality personnel with relevant expertise in these standards conducted and verified the testing.
4. Adjudication Method for the Test Set
Given that the performance testing is non-clinical and based on objective measurements against standards:
- There was no adjudication method (like 2+1 or 3+1 consensus) as this is typically applied to subjective human interpretation of patient data or images.
- The results are either a "Pass" or "Fail" based on whether the device meets the defined quantifiable specifications of the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- No MRMC comparative effectiveness study was done.
- The device described is an RF Generator, a piece of medical hardware. It does not involve AI or human-in-the-loop performance improvement with AI assistance.
- The document explicitly states: "Substantial equivalence is not dependent upon clinical data and no clinical testing was performed."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No standalone (algorithm-only) performance was done.
- As noted above, this device is hardware (an RF generator) and does not involve an algorithm for diagnostic or interpretative purposes.
7. The Type of Ground Truth Used
For the non-clinical performance testing, the "ground truth" used was:
- Engineering Specifications and Recognized Medical Device Standards: These include IEC 60601-1-1, IEC 60601-1-2, IEC 60601-2-2, IEC 62304, IEC 60601-1-6, IEC 62366-1, and FDA guidance documents for software and human factors.
- Relievant Specified Requirements: Internal requirements set by the manufacturer for mechanical testing.
8. The Sample Size for the Training Set
- Not applicable. This document describes non-clinical performance testing of a hardware device (RF Generator). There is no "training set" in the context of machine learning or AI that would produce diagnostic results.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set mentioned or implied for this medical device, there is no ground truth established for it.
§ 882.4400 Radiofrequency lesion generator.
(a)
Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.(b)
Classification. Class II (performance standards).