(72 days)
Smith & Nephew RF Denervation Probes and 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 Cannulae. The Smith & Nephew Denervation Probe is packaged non-sterile for reuse. The Smith & Nephew RF Cannulae are offered in a variety of sizes and tip configurations, and are packaged sterile for single use.
Based on the provided text, the device in question is the Smith & Nephew RF Denervation Probes & RF Cannulae. The document is a 510(k) Summary of Safety and Effectiveness, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed clinical performance data against specific acceptance criteria for a new device.
Therefore, the information for many of your requested points is not present in this document. The existing information primarily relates to electrical safety standards.
Here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical safety standards (UL 60601-1) | The device meets the requirements of UL 60601-1 when used in combination with the Smith & Nephew Electrothermal® 20S Spine System Generator. |
| Electrical safety standards (IEC 60601-1) | The device meets the requirements of IEC 60601-1 when used in combination with the Smith & Nephew Electrothermal® 20S Spine System Generator. |
| Substantial Equivalence to Predicate Device | The Smith & Nephew RF Denervation Probes & RF Cannulae are substantially equivalent in design, materials, function, and intended use to the predicate device: Smith & Nephew RF Denervation Probes and RF Cannulae (K034012). (This is a regulatory "acceptance criterion" for 510(k) clearance). |
2. Sample sized 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 document. The document refers to "Summary Performance Data" which only states compliance with electrical safety standards, not a clinical test set.
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)
This information is not provided in the document, as no clinical test set requiring expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document, as no clinical test set requiring adjudication is described.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done (or at least, not reported in this document). The device is a medical instrument (probe and cannula), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a medical instrument, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided as no clinical performance study with a defined ground truth is described. The performance data presented relates to engineering standards (electrical safety).
8. The sample size for the training set
This information is not provided. The document describes a medical device, not a machine learning model, so there is no "training set" in the context of AI.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for an AI model.
Summary of the Study and Device Proof:
The "study" described in this 510(k) summary is not a clinical performance study in the traditional sense, but rather a demonstration of substantial equivalence to a previously cleared predicate device (Smith & Nephew RF Denervation Probes & RF Cannulae, K034012) and compliance with electrical safety standards.
- The device meets the requirements of UL 60601-1 and IEC 60601-1 electrical safety standards when used with a specific generator (Smith & Nephew Electrothermal® 20S Spine System Generator). This compliance serves as the "proof" for these specific acceptance criteria.
- The primary "proof" for regulatory clearance is the argument that the new device is substantially equivalent in design, materials, function, and intended use to the predicate device. This argument itself is the "study" for 510(k) purposes, rather than a clinical trial with 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).