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The Stryker Interventional Pain RF Generator, in combination with the Stryker RF Electrodes and Cannulae, is intended for coagulation of soft tissues in orthopedic, arthroscopic, spinal, and neurosurgical applications. 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 Interventional Pain RF Generator, in combination with the Stryker RF Electrodes and Cannulae, is intended for coagulation of soft tissues in orthroscopic, spinal, and neurosurgical applications.

This document, K032601, is a 510(k) premarket notification for the Stryker Interventional Pain RF Generator. It states that the device is substantially equivalent to existing marketed devices and does not contain information regarding acceptance criteria or a study proving the device meets specific acceptance criteria in the manner requested.

Specifically, the document focuses on:

• Establishing substantial equivalence to predicate devices (Oratec, Radionics, Baylis, NeuroTherm, and Arthrocare) based on intended use, safety, and effectiveness.
• Indications for Use: coagulation of soft tissues in orthopedic, arthroscopic, spinal, and neurosurgical applications (e.g., Facet Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminal Neuralgia, Peripheral Neuralgia, and Rhizotomy).
• Regulatory Classification: Class II, Product Code GXD (Generator, Lesion, RF).

There is no detailed information in this document about:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance. This document uses a "substantial equivalence" argument, not data from a specific study to prove performance against criteria.
3. Number or qualifications of experts used to establish ground truth.
4. Adjudication method.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study, including effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document's purpose is to seek FDA clearance for market entry by demonstrating substantial equivalence to already legally marketed devices, implying that if the predicate devices met safety and effectiveness standards, this new device, being "equivalent," also meets them without needing new, extensive performance studies as might be seen for novel devices.

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