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The Stryker MultiGen™ 2 RF Generator, in combination with the Stryker MultiGen 2 Electrodes and RF Cannulae, are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.

The Stryker Venom MultiGen 2 Electrodes, in combination with the Stryker RF Cannulae and Stryker MultiGen™ 2 RF Generator, are intended for coagulation of soft tissue in orthopedic, spinal, and neurosurgical applications. These products are also used for selective denervation and tissue destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the peripheral nerve, and nerve roots for the relief of pain. Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.

The Stryker MultiGen 2 Electrodes, in combination with the Stryker RF Cannulae and Stryker MultiGen™ 2 RF Generator, are intended for coagulation of soft tissue in orthopedic, spinal, and neurosurgical applications. These products are also used for selective denervation and tissue destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the peripheral nerve, and nerve roots for the relief of pain. Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia and Rhizotomy.

The Stryker RF Cannulae, in combination with Stryker Electrodes and the Stryker RF Generator, Stryker MultiGen, or Stryker MultiGen™ 2 RF Generator, are intended for coagulation of soft tissue in orthopedic, spinal, and neurosurgical applications. They are also used for selective denervation and destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the peripheral nerve, and nerve roots for the relief of pain. Examples include, but are not limited to: Facet Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.

The MultiGen™ 2 RF Generator system is a bipolar and monopolar, high frequency electrosurgical system. The MultiGen 2 RF Generator will be used in conjunction with the MultiGen 2 Splitter Cable, MultiGen 2 Electrodes, RF Cannulae, and other accessories to produce lesions by the direct application of radiofrequency currents. The generator applies temperature-controlled, radiofrequency (RF) energy into the electrode. During lesion creation, targeted nerve tissue is exposed to RF energy using an active electrode inserted into an insulated cannula with an uninsulated tip. The application of RF energy causes a thermal reaction at the targeted nerve tissue site to create a lesion.

This document is a 510(k) Pre-market Notification for a medical device, specifically the Stryker MultiGen™ 2 RF Generator System. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials for novel devices.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to demonstrating substantial equivalence through a combination of comparisons to predicate devices, and various types of performance testing (electrical safety, EMC, software V&V, and bench testing). There are no clinical studies or human reader performance studies mentioned for this device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device, meaning the new device should have similar or equivalent technical characteristics and performance to the previously cleared device. The "performance" refers to the results of various verification tests showing the device operates within its specifications and performs similarly to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a numerical sample size for a "test set" in the context of clinical data. This submission relies on a comparison to a predicate device and various engineering tests. For the engineering tests:
  • "Substantial equivalence testing verifying the radiofrequency ablations created by the subject device are equivalent to the radiofrequency ablations created by the predicate device." - The number of tests/data points is not specified.
  • "Multi-Lesion testing verifying that the MultiGen 2 RF Generator system functions properly with all possible set ups and procedural variations." - The number of test cases/scenarios is not specified.
  • "MultiGen 2 Splitter Cable (Splitter Cable) life testing." - The number of cables tested and duration is not specified.
  • "MultiGen 2 Electrode NOVRAM testing showing that the NOVRAM meets specifications." - The number of electrodes tested is not specified.
  • "MultiGen 2 RF Generator current limitation testing." - The number of tests is not specified.
• Data Provenance: Not specified. This submission is about the device's technical specifications and engineering testing, not typically patient-derived data. The tests are bench tests conducted by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This submission relies on engineering and performance testing against specifications and comparison to the predicate device's established characteristics. There is no concept of "ground truth" derived from expert interpretation (e.g., of medical images) in this context.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication process for this type of submission (engineering and performance testing).

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

No. This document explicitly states: "No clinical studies were performed to support substantial equivalence." The device is not an AI-assisted diagnostic tool; it is a radiofrequency generator used for soft tissue coagulation.

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

Not applicable. This is a medical device (RF Generator), not an algorithm or AI system. Its performance is evaluated through engineering and bench testing, as well as comparison to its predicate device. This is analogous to "standalone performance" in the sense that the device's functional integrity is tested on its own and with its accessories.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering specifications, design requirements, and the performance characteristics of its legally marketed predicate device. For example, the accuracy of temperature measurement or the output power range are compared against the established parameters of the predicate and internal design specifications, not against clinical outcomes or pathology.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no "training set."

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