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The LesionPoint RF Cannula is indicated for use in RF heat lesion procedures for the relief of pain.

The LesionPoint RF Cannula is used in conjunction with the commercially available Cosman RFG-1A Lesion Generator (K050084) to create radiofrequency (RF) heat lesions for the treatment of pain. The LesionPoint RF Cannula is a stainless steel cannula with an insulated shaft having an exposed (uninsulated) tip to deliver the RF energy to the tissue. The LesionPoint RF Cannula is provided as a sterile, single use, disposable device. The LesionPoint RF Cannula will be available in a variety of lengths and gauges. The LesionPoint RF Cannula is provided sterile packed, and is labeled for Single Use Only.

The provided 510(k) summary for the LesionPoint RF Cannula does not contain acceptance criteria or detailed study information.

The summary states:

1. Non-Clinical Data: "Cosman Medical has done bench testing on the LesionPoint RF Cannula to confirm performance characteristics of this device."
2. Conclusion: "The comparison to the predicate device demonstrates that the LesionPoint RF Cannula is safe and effective and is substantially equivalent to the predicate devices."

This document is a marketing application for a medical device seeking substantial equivalence to existing predicate devices. For such applications, detailed performance metrics, acceptance criteria, and comprehensive study results like those requested are typically not included in this summary document. The FDA determines substantial equivalence based on the device's intended use, technological characteristics, and safety and effectiveness information compared to predicates, often relying on a combination of bench testing, comparisons to predicate devices, and sometimes (but not always for 510(k)s) clinical data.

Therefore, for the specific questions:

1. A table of acceptance criteria and the reported device performance: Not provided in the document. The document only mentions "bench testing...to confirm performance characteristics." No specific metrics or acceptance criteria are reported.
2. Sample size used for the test set and the data provenance: Not provided. The document only mentions "bench testing." No details on sample size or data provenance (e.g., country, retrospective/prospective) are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. The document doesn't describe a test set requiring expert ground truth for performance evaluation of classification or diagnostic accuracy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not provided.
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 cannula, not an AI diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/not provided. The device undergoes "bench testing," which typically involves engineering and physical property measurements rather than ground truth based on clinical or expert consensus.
8. The sample size for the training set: Not applicable/not provided. The document doesn't mention a training set, as it's not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable/not provided.

In summary, the provided 510(k) documentation focuses on demonstrating substantial equivalence to predicate devices through physical and technical characteristic comparisons and general bench testing, rather than detailed performance studies with specific acceptance criteria as might be seen for novel diagnostic or AI-powered devices.

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