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The gammaCore-2 Non-invasive Vagus Nerve Stimulator is intended to provide noninvasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore-2 device is indicated for the acute treatment of pain associated with episodic cluster headache in adult patients.

gammaCore-2 is a device that provides non-invasive Vagus Nerve Stimulation (nVNS) when applied to the side of the neck. This is a mild electrical stimulation of the vagus nerve, which runs through the neck and carries information to the central nervous system. Each stimulation with gammaCore-2 lasts two minutes. The patient controls the stimulation strength.

This document describes the gammaCore-2 device and its substantial equivalence to a predicate device (gammaCore-S). It's a 510(k) submission, which focuses on demonstrating equivalence rather than proving de novo safety and effectiveness. Therefore, the information provided is tailored to that purpose.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission like this, "acceptance criteria" and "device performance" are typically framed in terms of meeting recognized standards and demonstrating that the modified device is as safe and effective as the predicate device, rather than explicit numerical performance metrics for a clinical indication. The document states that clinical studies were not required to validate the modifications.

The acceptance criteria are implied by the conformity to various IEC standards and the verification/validation activities. The "reported device performance" is that these activities demonstrated that the predetermined acceptance criteria have been met.

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

This document does not describe a clinical "test set" in the traditional sense of a study involving human subjects for performance evaluation of the device's indications for use. The testing described is primarily nonclinical verification and validation testing against engineering standards and risk analysis. Therefore, there is no information on:

• Sample size for a test set (clinical data was not required for the modifications).
• Data provenance (country of origin, retrospective/prospective).

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

Since no clinical test set for performance evaluation was involved, this information is not applicable and not provided in the document. The evaluation was focused on engineering and design changes.

4. Adjudication Method for the Test Set

As there was no clinical test set in the context of performance studies, no adjudication method is mentioned or relevant to this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically for image-based diagnostic devices to assess human reader performance with and without AI assistance. The gammaCore-2 is an external vagal nerve stimulator, and its modifications (user interface, charging) did not necessitate such a study.

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

Not applicable/Not done. The gammaCore-2 is a nerve stimulator, not an algorithm or AI system for standalone performance evaluation in the way this question typically implies (e.g., in diagnostic imaging AI). The "device performance" here refers to its physical and functional attributes, not an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established engineering standards and safety/performance requirements outlined in the IEC and ISTA standards, as well as the functional specifications for the device's wireless charging and battery performance. The device's performance was validated against these predetermined technical criteria. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for the modifications described in this 510(k).

8. The Sample Size for the Training Set

Not applicable/Not provided. There is no "training set" mentioned or implied, as this is not an AI/machine learning device that would require a training set for model development. The submission focuses on hardware and software modifications and their compliance with existing standards.

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

Not applicable/Not provided. As mentioned above, there is no training set for an AI/ML model.

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