(64 days)
The Smith & Nephew ElectroThermal® 20S Spine System is intended to create lesions in nervous tissue, and to coagulate and decompress disc material when used in combination with Smith & Nephew thermal/coagulating probes. The generator and accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
The proposed Smith & Nephew ElectroThermal® 20S Spine generator is a 20-watt electrothermal generator. It is intended to be used to create lesions in nervous tissue and to coagulate and decompress material when used in combination with Smith & Nephew thermal/coagulating probes. The generator provides temperature and impedance monitoring of energy to maintain effective tissue heating during temperature controlled applications. Smith & Nephew ElectroThermal® 20S Spine generator is designed to be used in conjunction with Smith and Nephew Spine products. These products include the Smith & Nephew SpineCATH® Intradiscal Catheter, the Smith & Nephew Decompression Catheter and the Smith & Nephew RF Denervation Probe and Smith & Nephew RF Probe.
The provided document is a 510(k) summary for the Smith & Nephew ElectroThermal® 20S Spine Generator, which details its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the manner of a clinical trial for diagnostic performance.
Therefore, the detailed information requested regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not available in this document, as it pertains to performance studies typically conducted for devices with diagnostic or AI components. This submission is for an electrosurgical generator, and the "performance data" referred to is about its functional equivalence to other similar generators.
Here's an interpretation of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it establishes substantial equivalence based on technological characteristics and functional performance compared to predicate devices. The "reported device performance" is the demonstration of this substantial equivalence.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicates) | Reported Device Performance (Summary) |
|---|---|
| Control and monitor temperature (like ORA-50 S and RFG-3C Plus) | The Smith & Nephew ElectroThermal® 20S Spine Generator controls and monitors temperature. |
| Monitor impedance (like ORA-50 S and RFG-3C Plus) | The Smith & Nephew ElectroThermal® 20S Spine Generator monitors impedance. |
| Use RF energy to thermally heat SpineCATH® and Decompression catheters (like ORA-50 S) | The Smith & Nephew ElectroThermal® 20S Spine Generator uses RF energy to thermally heat the SpineCATH® and Decompression catheters. |
| Provide preset settings for time and temperature to deliver RF (like ORA-50 S) | The Smith & Nephew ElectroThermal® 20S Spine Generator provides preset settings for time and temperature to deliver RF. |
| Use a biphasic square wave to deliver stimulation voltage (like RFG-3C Plus) | The Smith & Nephew ElectroThermal® 20S Spine Generator uses a biphasic square wave to deliver stimulation voltage. |
| Use temperature controlled RF energy to create lesions in nervous tissue (like RFG-3C Plus) | The Smith & Nephew ElectroThermal® 20S Spine Generator uses temperature-controlled RF energy to create lesions in nervous tissue. |
| Deliverance of temperature and time of RF controlled energy (overall functional performance) | "The performance testing conducted on the Smith & Nephew ElectroThermal® 20S Spine generator demonstrates substantial equivalents to the Radionic's RFG-3C Plus Lesion Generator clarified in K982489 and the Smith & Nephew ORA-50 S clarified in K993854 based on deliverance of temperature and time of RF controlled energy." (This indicates the device functionally performs these tasks comparably to the predicate devices.) |
2. Sample size used for the test set and the data provenance
- Not Applicable. This document describes a 510(k) submission for an electrosurgical generator, focusing on its substantial equivalence to predicate devices based on technological characteristics and functional performance rather than diagnostic accuracy or clinical outcomes tested on a "test set" of patient data. Performance testing would typically involve engineering and bench testing to confirm the generator's output parameters match those of the predicate, not a "test set" of patient data in the context of diagnostic AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. Ground truth, in the context of diagnostic performance, is not relevant here as this is an electrosurgical device. The "ground truth" for its functional performance would be established by engineering specifications and measurements.
4. Adjudication method for the test set
- Not Applicable. See point 3.
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 an electrosurgical generator, not an AI-powered diagnostic tool. MRMC studies are for diagnostic accuracy, typically involving human readers interpreting images with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm but an electrosurgical device. Its performance is evaluated through engineering and functional tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Implied Ground Truth: For this type of device, the "ground truth" for its performance would be established through engineering specifications, bench testing, and functional measurements to ensure that the device generates the correct RF energy, monitors temperature and impedance accurately, and performs its intended electrosurgical functions within established parameters that are comparable to the predicate devices. This is not derived from clinical outcomes or expert consensus on patient data.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of an electrosurgical generator. This terminology applies to machine learning algorithms.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.