(241 days)
The Stryker RF Electrodes and Cannulae, in combination with the Stryker RF Generator, are intended for coagulation of soft tissues in orthopedic, arthroscopic, 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 Electrodes and Cannulae, in combination with the Stryker RF Generator, are intended for coagulation of soft tissues in orthopedic, arthroscopic, 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 provided text is a 510(k) premarket notification for the Stryker RF Electrodes and Cannulae. This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device and therefore does not typically include detailed studies proving performance against acceptance criteria in the same way a novel device might.
Instead, the core of a 510(k) is to demonstrate that the new device is as safe and effective as an already approved device. The document explicitly states:
"The Stryker RF Electrodes and Cannulae are equivalent in intended use, safety, and effectiveness to a legally marketed predicate device submited by Stryker Instruments. The Stryker RF Electrodes and Cannulae do not raise and efficacy concerns when compared to similar devious an outly roget of these existing devices." (There appears to be a typo/parsing error in the original document, but the intent is clear.)
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication, MRMC studies, and standalone performance is not present in this 510(k) summary. These details are typically part of a Pre-Market Approval (PMA) application or a more extensive clinical validation for novel devices.
Here's a breakdown of why this information is absent:
- Acceptance criteria and reported device performance: Not applicable in a 510(k) in the way you're asking. The "performance" is implicitly deemed acceptable because it's equivalent to an already approved predicate.
- Sample size, data provenance: Not relevant for a substantial equivalence claim.
- Number/qualifications of experts, adjudication: Not relevant. The "ground truth" here is the established safety and efficacy of the predicate device.
- MRMC comparative effectiveness study: Not typically part of a 510(k) for devices like electrodes and cannulae.
- Standalone performance: Not explicitly proven as a new device.
- Type of ground truth: The "ground truth" is the performance of the legally marketed predicate device.
- Sample size for training set: Not applicable, as this is not an AI/algorithm-driven device requiring a training set.
- How ground truth for training set was established: Not applicable.
In summary: The provided document demonstrates "substantial equivalence" to a predicate device, which is a different regulatory pathway than proving novel performance against acceptance criteria through independent studies.
§ 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).