(28 days)
Smith & Nephew RF Cannulae are intended to facilitate placement of Smith & Nephew RF Denervation Probes. The Smith & Nephew RF 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. 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 the regulatory clearance for the Smith & Nephew RF Cannulae. It does not contain information about a study proving the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or improvement with AI assistance. Instead, it focuses on the device's substantial equivalence to a predicate device and its compliance with electrical safety standards.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety Standards (UL 60601-1 and IEC 60601-1) | Meets the requirements of electrical safety standards for UL 60601-1 and IEC 60601-1 when used in combination with the Smith & Nephew Electrothermal® 20S Spine System Generator. |
| Substantial Equivalence to Predicate Device | Determined by FDA to be substantially equivalent to Smith & Nephew RF Probe and Cannulae (K034012) in design, materials, function, and intended use. |
2. Sample size used for the test set and the data provenance:
- Not applicable. The document describes a regulatory submission based on substantial equivalence and compliance with safety standards, not a performance study on a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No such test set or ground truth establishment by experts is mentioned in the provided text.
4. Adjudication method for the test set:
- Not applicable. No adjudication method is described as there is no performance study or test set using patient data.
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:
- No. An MRMC study was not done, and the device is a medical cannulae, not an AI-assisted diagnostic tool. Therefore, there's no mention of human reader improvement with or without AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. The device is a physical medical instrument, not an algorithm. Therefore, no standalone algorithm performance study was conducted.
7. The type of ground truth used:
- Not applicable. The "ground truth" in this context is the existing predicate device and established electrical safety standards, not clinical outcomes data or pathology from a study. The device's "performance" is primarily assessed against these regulatory and technical benchmarks.
8. The sample size for the training set:
- Not applicable. This device is hardware, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for a machine learning model, this question is not relevant.
In summary: The provided document is a 510(k) summary for a medical device (RF Cannulae) seeking regulatory clearance. It focuses on demonstrating substantial equivalence to a legally marketed predicate device and compliance with relevant electrical safety standards. It does not describe a clinical study with performance metrics, patient data, or expert-established ground truth in the way one would expect for an AI-enabled diagnostic or prognostic device. The "study" mentioned is the evaluation of the device against standards and comparison to an existing device, rather than a prospective clinical performance trial.
§ 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).