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The Stryker Intradiscal RF Generator is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The Stryker Intradiscal RF Generator will be used with the previously cleared Stryker RF Intradiscal Adapter and catheters such as Smith & Nephew Spinecath™ & Acutherm™ catheters.

The Stryker Intradiscal RF Generator when used with the separately cleared Stryker RF Intradiscal Adapter and the separately cleared Smith & Nephew SPINECATH™ Intradiscal Catheter (K993967) ACUTHERM ™ Decompression Catheter is is intended for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs.

The provided documentation, K063489, is a 510(k) Summary for the Stryker Intradiscal RF Generator, submitted in 2007. It establishes substantial equivalence to a predicate device, the Smith & Nephew ElectroThermal 20S Spine Generator (K033981), rather than presenting a study with specific acceptance criteria and performance data for the Stryker device itself.

Therefore, many of the requested details regarding a study proving acceptance criteria are not directly available in this document. The submission asserts equivalence based on intended use, technological characteristics, operating principles, and similar performance characteristics.

Here’s an analysis based on the provided text, indicating what is not present in the document due to its nature as a 510(k) summary relying on predicate equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not Applicable. This 510(k) submission does not describe a new clinical or performance study with a test set for the Stryker Intradiscal RF Generator. It relies on the substantial equivalence to a previously cleared device.

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):

• Not Applicable. No test set or ground truth establishment by experts is described for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. No test set or adjudication method 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:

• Not Applicable. The device is a radiofrequency generator, not an AI-based diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant and not present in this document.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not Applicable. The device is a physical medical instrument (RF generator), not an algorithm or AI system. Its performance is evaluated through its physical and electrical characteristics, and its safety relies on its design and manufacturing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not Applicable. As no specific performance study for this device is detailed, no ground truth data type is mentioned. The submission relies on the predicate device's established safety and effectiveness.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device, so the concept of a "training set" is not relevant.

9. How the ground truth for the training set was established:

• Not Applicable. As above, this is not an AI/machine learning device.

Summary of the K063489 Submission:

The K063489 submission for the Stryker Intradiscal RF Generator establishes substantial equivalence to the Smith & Nephew ElectroThermal 20S Spine Generator (K033981). This means that instead of conducting new performance studies, the applicant demonstrated that their device shares the same intended use, technological characteristics, operating principles, and similar performance characteristics as a device already legally marketed. Therefore, the detailed information typically found in a clinical or performance study (such as acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies) is not provided in this 510(k) summary for the Stryker device itself. The FDA cleared the device based on this comparative assessment.

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