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The Gyrus ENT Nerve Stimulator is intended to provide electrical stimulation to cranial and peripheral motor nerves to aid in nerve location during surgical procedures.

The Gyrus ENT Nerve Stimulator that is described in this notification has the same technological characteristics, power modality and mode of operation as the predicate device.

This 510(k) summary describes a traditional medical device, the Gyrus ENT Nerve Stimulator, not an AI/ML-powered device. Therefore, the specific questions regarding AI/ML study design, such as acceptance criteria based on AI performance metrics, sample sizes for AI training/test sets, expert adjudication for ground truth, MRMC studies, or standalone algorithm performance, are not applicable.

The submission focuses on demonstrating substantial equivalence to a predicate device (Neurosign Model 100) based on intended use and technological characteristics, as well as adherence to established safety standards.

Here's a breakdown of the requested information based on the provided text, adapted for a non-AI/ML device:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for the Gyrus ENT Nerve Stimulator appear to be compliance with specific electrical safety and electromagnetic compatibility (EMC) standards. The "reported device performance" is its successful testing against these standards.

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 to this type of device submission. This is a traditional electrical medical device, and its performance is evaluated against engineering and safety standards, not through a clinical test set of patient data.

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. Ground truth as typically defined for AI/ML models (e.g., expert-labeled data) is not relevant here. The "ground truth" for this device's performance would be verifiable compliance with the specified safety and EMC standards, likely assessed by expert engineers and testing laboratories.

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

Not applicable. There is no "test set" in the context of patient data requiring adjudication for this type of device.

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 is not an AI-assisted device.

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

Not applicable. This is not an algorithm-only device.

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

The "ground truth" for this device's regulatory acceptance is its adherence to universally recognized and specified electrical safety (UL2601/IEC 601) and electromagnetic compatibility (IEC 601-1-2) standards. This is not a biological or clinical ground truth, but an engineering and regulatory one, confirmed through compliance testing.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that undergoes a training phase.

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

Not applicable.

Summary of the Study/Evidence Provided:

The provided documents describe a 510(k) submission for the Gyrus ENT Nerve Stimulator. The "study" mentioned is not a clinical trial in the typical sense for AI/ML devices, but rather a demonstration of substantial equivalence to an existing predicate device (Neurosign Model 100) and adherence to established safety and EMC standards.

• Substantial Equivalence: The submission asserts that the Gyrus ENT Nerve Stimulator has the same intended use and similar technological characteristics (e.g., power supply, current range, probe support) as the predicate device, the Neurosign Model 100. Differences in frequency settings and current display are noted but considered not to raise new issues of safety or effectiveness.
• Safety and Performance Testing (Implicit): The device is stated to be "designed to meet" UL2601/IEC 601 for various AC voltages and IEC 601-1-2 for EMC. This implies that testing was conducted or design validated to ensure compliance with these international electrical safety and electromagnetic compatibility standards. The compliance with these standards serves as the performance demonstration for the safety aspects of the device.

In conclusion, for this traditional nerve stimulator, the "acceptance criteria" revolve around established regulatory pathways for medical devices: demonstrating substantial equivalence to a predicate and compliance with recognized safety and performance standards, rather than clinical performance metrics in a study with patient data.

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