(83 days)
The Smith & Nephew RF Denervation Probes and Cannulae are indicated for use in RF heat lesion procedures for the relief of pain.
The Smith & Nephew RF Denervation Probe is a temperature sensing electrode designed for use in radiofrequency lesion procedures. The RF Denervation Probe is used with a disposable Smith & Nephew RF Cannula. The Smith & Nephew RF Denervation Probe is packaged non-sterile for reuse. Smith & Nephew RF Cannulae are offered in a variety of sizes and tip configurations. The RF Cannulae are packaged sterile for single use.
The provided text describes a 510(k) summary for the Smith & Nephew RF Denervation Probes & RF Cannulae. For devices cleared through the 510(k) process, the primary "study" that proves the device meets acceptance criteria is a demonstration of substantial equivalence to legally marketed predicate devices. This typically involves performance data showing the new device functions similarly and safely to the predicate, rather than an extensive clinical trial designed to prove clinical efficacy.
Therefore, the requested information focusing on AI-specific metrics (like MRMC studies, standalone algorithm performance, training/test set sizes, expert adjudication for ground truth) is not applicable to this type of device and submission. The document explicitly states: "The Smith & Nephew RF Denervation Probes & RF Cannulae are substantially equivalent in design, materials, function and intended use to the following devices cleared for commercial distribution: Radionics Racz-Finch Electrode K870028 and Radionics Disposable RF Cannulae K980430."
However, the document does contain information about performance data related to electrical safety standards.
Here's the breakdown based on the available information:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety Standards: Compliance with UL 60601-1 and IEC 60601-1 | The Smith & Nephew RF Denervation Probes & RF Cannulae meet the requirements of UL 60601-1 and IEC 60601-1 when used in combination with the Smith & Nephew Electrothermal® 20S Spine System Generator. |
| Substantial Equivalence to Predicate Devices (Radionics Racz-Finch Electrode K870028 and Radionics Disposable RF Cannulae K980430) in design, materials, function, and intended use. | The device is deemed substantially equivalent to the predicate devices. |
Study Details (Based on available 510(k) summary)
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a separate "test set" in the context of a clinical performance study. The 510(k) process relies on demonstrating equivalence through technical characteristics and a summary of performance data (like electrical safety testing).
- Data Provenance: Not applicable in the context of a clinical trial for substantial equivalence based on technical standards and comparisons. The performance data relates to general electrical safety testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for algorithm performance (e.g., in AI/ML studies) is not part of this 510(k) submission. The "ground truth" for substantial equivalence is the established performance and safety of the predicate devices and compliance with recognized standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. There was no clinical study requiring adjudication of expert interpretations as described.
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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 not an AI-assisted diagnostic or imaging device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a medical instrument (probe and cannula), not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this submission are the established safety and performance requirements of electrical safety standards (UL 60601-1, IEC 60601-1) and the characteristics of the legally marketed predicate devices.
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The sample size for the training set: Not applicable. This device is not an AI-based system that requires a training set.
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How the ground truth for the training set was established: Not applicable.
Summary Rationale:
The provided document is a 510(k) summary for medical devices (RF Denervation Probes and Cannulae). The 510(k) pathway is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving independent clinical effectiveness through extensive clinical trials as would be required for a novel device or an AI/ML product. The "study" here is primarily a technical comparison and confirmation of compliance with relevant industry standards (electrical safety), rather than a clinical trial with human subjects, ground truth panels, or AI performance metrics.
§ 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).