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

The gammaCore-S device (Catalog # 10009-40601 gammaCore-S, 31 day, 300 treatment device) is a hand-held portable device consisting of an outer plastic case, a battery, signal generating and amplifying electronics, LED and horn (indicate device status), and a pair of stainless steel skin contact surfaces (referred to as the "stimulation surfaces"). The device operating status is visible on a LCD display screen. Caps are provided to cover the stimulation surfaces when the device is not in use. Conductive electrode gel is provided for use with the device.

The gammaCore-S device produces a low voltage electric signal consisting of five 5000 Hz pulses that are repeated at a rate of 25 Hz. The waveform of the electric pulses is approximately a sine wave with a peak voltage limited to 24 Volts when placed on the skin and a maximum output current of 60mA. The signal is transmitted through the skin of the neck to the vagus nerve. The device allows up to 30 seconds for the operator to position and adjust the stimulation intensity, treatment is intended to be applied for 90 seconds (the treatment automatically stops 120 seconds after the device is powered on). Each device allows for multiple treatments (up to 300 2-minute treatments).

The document provided is a 510(k) Pre-market Notification from the FDA regarding the gammaCore-S device. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and efficacy through a de novo clinical trial with defined acceptance criteria for individual performance metrics.

Therefore, the typical structure for outlining acceptance criteria and a study proving a device meets them (as would be seen for a new device requiring a full PMA or specific performance claims in a de novo classification) is not directly applicable here.

However, I can extract the relevant information from the provided text that describes the evidence used to support the expanded indication for migraine headaches, which implicitly serves the purpose of demonstrating that the device is "substantially equivalent" for this new indication.

Here's how the information aligns with your requested points, with an emphasis on how "substantial equivalence" is demonstrated rather than strict performance acceptance criteria for a novel device:

Device: gammaCore-S
Indication Expansion: Acute treatment of pain associated with migraine headache in adult patients.
Predicate Device: gammaCore-S (K171306), indicated for acute treatment of pain associated with episodic cluster headache.

1. Table of "Acceptance Criteria" (Implicit for Substantial Equivalence) and Reported Device Performance

As this is a 510(k) for an expanded indication of an identical device, the "acceptance criteria" are not reported as specific performance metrics (e.g., sensitivity, specificity, accuracy) like they would be for a diagnostic AI. Instead, the "acceptance criteria" are implicitly met by demonstrating safety and effectiveness for the new indication, showing superiority over sham, and confirming no new safety or effectiveness questions.

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

• Sample Size: The document does not explicitly state the total number of patients enrolled but describes it as a "multicenter" study.
• Data Provenance: The study was conducted across 10 expert headache centers in Italy from January 11, 2016, through March 31, 2017. It was a prospective, randomized, double-blind, parallel-group, sham-controlled clinical study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable in the context of this 510(k) submission. The "ground truth" here is the patient's subjective experience of pain and its resolution, as measured by standard clinical pain scales and reported outcomes in a sham-controlled trial. There are no "experts" establishing a "ground truth" in the sense of image annotation or disease diagnosis for an AI algorithm. The study was conducted by medical professionals at "expert headache centers."

4. Adjudication Method for the Test Set

Not explicitly stated regarding an adjudication method in the context of expert review. The study was a randomized, double-blind, parallel-group, sham-controlled study, which is the primary method of minimizing bias and establishing the effectiveness of the treatment itself. Blinding (patient and potentially assessor) serves a similar purpose to adjudication in ensuring unbiased outcome assessment.

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

No, an MRMC study was not conducted. This is not an AI-assisted diagnostic device where human readers interact with AI. It is a direct treatment device where patients use the device themselves.

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

Yes, in a sense. The "standalone" performance here refers to the device's ability to treat migraine pain when used by patients, as compared to a sham device. The clinical study directly assessed the device's therapeutic effect (i.e., its "performance") in real-world use by patients. There isn't an "algorithm" in the typical AI sense that would have separate standalone performance metrics (like AUC or accuracy) outside of its direct therapeutic application.

7. The Type of Ground Truth Used

The ground truth was based on patient-reported outcomes and clinical assessments of pain, pain intensity, and responder rates, as documented in a randomized controlled trial. This is directly tied to the primary and secondary endpoints:

• Primary Endpoint: Aborting the first treated attack at 30, 60, and 120 minutes.
• Secondary Endpoints: Mild or no pain at 120 minutes, changes in pain intensity from baseline, and ≥50% responder rates (pain-free and mild/pain-free) at 120 minutes.
• Safety Data: Adverse events reported.

8. The Sample Size for the Training Set

This is not applicable. The gammaCore-S is a direct treatment device, not an AI/ML algorithm that requires a "training set" in the computational sense. The clinical study served as a validation of the device's effectiveness for the expanded indication.

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

Not applicable, as there is no "training set" in the AI/ML context for this device. Ground truth (patient outcomes) was established through direct measurement and reporting in a clinical trial setting using standard pain assessment methodologies.

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

gammaCore-S 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-S lasts two minutes. The patient controls the stimulation strength.

This document is a 510(k) premarket notification for the gammaCore-S device, which is an external vagal nerve stimulator for headache. The document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria.

The document states:

• "Clinical Data: Clinical studies were not required to validate the modifications in the gammaCore-S."
• "The verification and validation activities, as identified by the risk analysis to ensure that the modified device is as safe and effective as the predicate device, have been completed and demonstrate that the predetermined acceptance criteria have been met."

Therefore, I cannot provide the requested information from this document because it explicitly states that clinical studies (which would typically contain such data) were not performed for this specific submission, as it relates to a modification of an already approved device.

To answer your request, a document detailing the clinical study or non-clinical performance data for the original gammaCore device (the predicate device) would be needed, or a document outlining the specific "predetermined acceptance criteria" and how they were met through non-clinical verification and validation activities for the gammaCore-S modifications.

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