(168 days)
The Stryker RF Coaxial Bipolar Electrodes and Cannulae, in combination with the Stryker RF Generator, are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. They are also used for selective denervation and tissue destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the spinal cord, peripheral nerves, and nerve roots for the relief of pain. Examples include, but are not limited to, Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.
The Stryker RF Coaxial Bipolar Electrodes and Cannulae will be used in conjunction with the Stryker RF Generator and Connector Cable to create radiofrequency lesions in nerve tissue. The generator applies temperature-controlled, radio frequency (RF) energy into targeted nerve tissue via an electrode probe. This energy destroys the nerve tissue's ability to conduct electrical signals. Pain relief is achieved by creating defined lesions on pain-conducting nerve fibers or tissue.
The two poles of the bipolar circuit will be referred to as RF1 and RF2. RF1 will define the sending pole while RF2 will define the return pole. Cannulae have both RF1 and RF2 Electrode connections. A secondary conductive surface (RF2) is offset axially to RF1 providing the return path for the RF energy. Thus the RF energy travels from the RF1 pole to the RF2 pole on the same probe. A lesion will be created between RF1 and RF2 on the singular probe.
This document is a 510(k) summary for the Stryker RF Coaxial Bipolar Electrodes and Cannulae. It states that the device is substantially equivalent to existing predicate devices. Therefore, the information typically found in a study demonstrating the device meets acceptance criteria (like specific performance metrics, sample sizes, expert qualifications, and study designs) is not present in this document.
The core argument for acceptance is substantial equivalence rather than direct performance testing against new acceptance criteria.
Here's how the requested information would apply to this document:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria and reported device performance because the device's acceptance is based on substantial equivalence to predicate devices, not on meeting new, specific performance metrics. The implicit "acceptance criteria" is that the device is as safe and effective as the predicate devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No new safety concerns compared to predicate devices | The document states: "The Stryker RF Coaxial Bipolar Electrodes and Cannulae do not raise any new safety and efficacy concerns when compared to similar devices already legally marketed." |
| Equivalent effectiveness to predicate devices | The document states: "The Stryker RF Coaxial Bipolar Electrodes and Cannulae are equivalent in intended use, safety, and effectiveness to existing devices being marketed by Stryker, Smith and Nephew and Baylis." |
2. Sample size used for the test set and the data provenance
Not applicable. No new test set data is presented for this 510(k) submission. The substantial equivalence argument relies on the established safety and effectiveness of the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new test set data where experts would establish ground truth is presented.
4. Adjudication method for the test set
Not applicable. No new test set data is presented.
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 electrode and cannulae, not an AI-assisted diagnostic or therapeutic tool with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm, but a physical medical device.
7. The type of ground truth used
Not applicable in the context of new performance data. The "ground truth" for the substantial equivalence argument is the existing regulatory approval and demonstrated safety/effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable. No training set for an algorithm is mentioned as this device is not an AI/ML product.
9. How the ground truth for the training set was established
Not applicable.
§ 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).