(90 days)
The Cosman G4 Radiofrequency Generator is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. The Cosman G4 Radiofrequency Generator is used with separately approved Cosman Radiofrequency Probes.
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This document is a 510(k) summary for the Cosman G4 Radiofrequency Generator, which is a medical device. This type of document focuses on establishing substantial equivalence to existing devices rather than presenting a detailed clinical study demonstrating acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance studies is not available in this filing.
Here's a breakdown of what can be extracted and what is not applicable:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail criteria in the provided text. The document states that "Performance testing was done to validate the intended use of the Cosman device." However, specific quantitative acceptance criteria (e.g., "output power must be within X% of target") are not detailed.
- Reported Device Performance: Not detailed in this summary. The 510(k) summary asserts "The comparison and performance test results in this 510(k) notification show that the Cosman G4 Radiofrequency Generator is substantially equivalent to the predicated devices and is safe and effective for the intended use." This indicates that performance data was collected and reviewed by the FDA, but the actual data and specific performance metrics are not included in this high-level summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided in the 510(k) summary. Performance testing is mentioned, but details about the test set, its size, or provenance are absent. For a radiofrequency generator, performance testing typically involves bench testing or animal studies, not human data sets in the way AI/ML devices do.
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)
- Not applicable/Not provided. For a device like a radiofrequency generator, "ground truth" would relate to its physical output and operational parameters rather than clinical diagnoses established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. This concept is typically relevant for studies involving human interpretation (e.g., image analysis for AI devices).
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
- Not applicable. This device is a radiofrequency generator, not an AI-assisted diagnostic tool or an imaging device that requires human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an algorithm-based device. Its performance is directly tied to its physical operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated. For a physical device like this, "ground truth" for performance testing would likely involve objective measurements of electrical output (e.g., power, impedance, temperature at the probe tip) against specifications, using calibrated equipment.
8. The sample size for the training set
- Not applicable. This is a hardware device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, this is not a machine learning device.
§ 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).