(63 days)
The Cosman Radiofrequency Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes, is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures.
Cosman RF Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes
Here's an analysis of the provided text regarding the Cosman RF Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes:
Important Note: The provided text is a 510(k) summary for a medical device. 510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than providing extensive de novo clinical trials to prove efficacy. Therefore, much of the requested information regarding detailed study design (like sample sizes for test and training sets, expert qualifications, MRMC studies, standalone performance, and specific ground truth establishment methods) is often not explicitly present in these types of documents. The focus is on showing similarity in intended use, technological characteristics, and performance data sufficient to establish equivalence.
Description of Acceptance Criteria and Study to Prove Device Meets Criteria
The Cosman RF Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes' acceptance criteria and the study proving it meets these criteria are framed within the context of a 510(k) premarket notification. This means the primary "acceptance criterion" is substantial equivalence to existing predicate devices.
The text states: "Performance testing was done to results in this 510(k) notification show that the Cosman RF Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes are substantially equivalent to predicate devices and are safe and effective for their intended use."
This implies that the "study" conducted was a comparison of the device's performance against the predicate devices to demonstrate that it operates safely and effectively in a similar manner. The document does not outline specific, quantitative acceptance criteria in the typical sense (e.g., "sensitivity must be >90%"). Instead, the acceptance is based on the demonstration of equivalent performance characteristics to the identified predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) submission, specific quantitative acceptance criteria in the format of a clinical trial endpoint are not explicitly listed. The "acceptance criterion" is proving substantial equivalence to predicate devices. The "reported device performance" would encompass various engineering and functional tests designed to demonstrate this equivalence and ensure the device functions as intended.
| Acceptance Criterion (Implied by 510(k) Process) | Reported Device Performance (Summary from Text) |
|---|---|
| Substantial Equivalence to Predicate Devices | Performance testing was conducted to demonstrate safety and effectiveness for intended use, showing substantial equivalence to predicate devices (Radionics RFG-3C Plus, Radionics SMK Sluijter-Mehta Kit, Radionics Microelectrode Kit, Diros Technology URF-2AP, Diros Technology URP-2A). |
| Safety and Effectiveness for Intended Use | Demonstrated to be "safe and effective for their intended use" through performance testing and comparison to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text. 510(k) submissions often rely on engineering and laboratory testing rather than large-scale human subject clinical trials for non-novel devices. If human data were used, the specifics are not detailed here.
- Data Provenance: Not explicitly stated. Given it's a device manufactured in the USA, it's likely testing was conducted domestically, but the text doesn't confirm this or specify whether data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. Again, for a 510(k) of this type, the "ground truth" often relates to engineering specifications and performance benchmarks, not subjective expert assessment of medical images or diagnostic outputs.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. It is unlikely that a formal adjudication process (like 2+1 or 3+1) was used, as this is typically applied in studies involving expert interpretation of data (e.g., radiology reads), which isn't the primary focus of this type of 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted (or at least, not reported in this summary). This type of study is more common for diagnostic imaging devices where human interpretation is a key component and the goal is to show improved reader performance with AI assistance. The Cosman device is a therapeutic lesion generator, not a diagnostic tool with AI.
- Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as no MRMC study was performed and the device does not involve AI assistance for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is a physical instrument for generating lesions, not an algorithm. Its performance is inherent in its operation and interaction with human users, not in a "standalone algorithm" sense.
7. The Type of Ground Truth Used
Given the nature of the device (a lesion generator), the "ground truth" would likely involve:
- Engineering specifications and performance metrics (e.g., output power accuracy, temperature control, impedance measurement).
- Bench testing to verify the ability to create lesions of appropriate size and characteristics in controlled environments or simulated tissue.
- Potentially, non-clinical (e.g., animal) studies to demonstrate lesion creation and safety without specific clinical outcome data being the "ground truth" for this 510(k).
- Comparison to the established performance characteristics of the predicate devices.
The provided text does not specify the exact nature of this "ground truth."
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The Cosman RF Lesion Generator is not an AI/machine learning device that requires a training set in the conventional sense. Its design and validation rely on established engineering principles and performance testing.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.
In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence to predicate devices, and as such, it does not contain the detailed clinical study information often associated with novel AI/software as a medical device (SaMD) clearances or PMAs. The "study" refers to the entire body of testing and comparison data submitted to the FDA to support the claim of substantial equivalence.
§ 882.4725 Radiofrequency lesion probe.
(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).