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The gammaCore Sapphire Non-invasive Vagus Nerve Stimulator is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore Sapphire device is indicated for:

• · The preventive treatment of migraine headache in adolescent (aged 12 and older) and adult patients
• The acute treatment of pain associated with migraine headache in adolescents (aged 12 and older) and adult patients
• · Adjunctive use for the preventive treatment of cluster headache in adult patients
• · The acute treatment of pain associated with episodic cluster headache in adult patients
• · Treatment of hemicrania continua in adults
• · Treatment of paroxysmal hemicrania in adults

The gammaCore Sapphire (gammaCore) is a multi-use, handheld, rechargeable, portable device consisting of a rechargeable battery and signal-generating and -amplifying electronics, with a slide control switch for user/operator control of the signal amplitude (relative range, 0-40 continuous).

The gammaCore Sapphire:

• . Includes a charging station incorporated into the "clamshell" storage case connected to a power adapter for charging of the device as necessary by the end user.
• Provides visible (light and display) and audible (beep) feedback regarding device and stimulation . status.
• Allows for multiple stimulations or doses; each stimulation or dose lasts 120 seconds, after . which the device automatically turns off unless turned off earlier by the user/operator. Note: One dose is defined as one stimulation cycle lasting 120 seconds (2 minutes).
• Delivers up to a fixed number of doses within a 24-hour period; once the maximum daily number . of doses has been reached, the device will not deliver any more doses until the following 24-hour period.
• Indicates on the display the number of remaining doses available in a 24-hour period.

The device will be provided to the patient/user with an initial 10-, 31-, or 93-day RFID card on the basis of the health care provider's prescription. Additional (refill/reload) cards will be provided in response to a user/patient request based on a prescription from his or her health care provider. The refill/reload RFID cards will be programmed by electroCore or its authorized agent. This is a specialized application for dispensing the device therapy.

When a 10-, 31-, or 93-day refill/reload card is requested by a patient/user (in accordance with a prescription from a health care provider) for a unique device serial number, an RFID card is encoded with the appropriate dosage according to the prescription. The gammaCore RFID card-loading application uses a proprietary encoding algorithm to encrypt the therapy days and doses per day on the refill/reload RFID card using near field communication protocols.

The encoded refill/reload RFID card is then provided to the user/patient who requested the refil/reload of the device, along with 1 to 6 additional tubes of conductive gel (the number of conductive gel tubes provided is based on the 10-, 31-, or 93-day refill/reload being provided). On receipt of the RFID card, the user/patient refills/reloads his or her gammaCore device by placing the RFID card across the face of the device (with the device turned on). The device will display "rd" and the "refill" icon as the device reads the RFID card. The device will signal (beeping twice) when it has been loaded with the programmed doses. The device will now be ready for use as treatment. The RFID card can be used for only one refill/reload; upon completion of the device refill/reload, the card can be thrown away.

In addition, a Bluetooth® feature will be enabled to facilitate diagnostics of any devices returned by patients/users to the manufacturer, to allow determination of the number of days the device was used and/or the number of doses as well as any days/doses remaining on the device. The Bluetooth feature will not be accessible to the patient/user; it is accessible only to the device manufacturer.

The subject device delivers the same energy and maintains the same operational characteristics as the gammaCore Sapphire device cleared in K203546. No changes in design or manufacturing process have been made that could affect device functionality. All functional aspects of the device remain the same as K203546, including the strength and nature of the device outputs.

The provided document is a 510(k) summary for the gammaCore Sapphire device, which is an external vagal nerve stimulator. It focuses on demonstrating substantial equivalence to a predicate device (gammaCore Sapphire, K203546) rather than detailing a study that proves the device meets specific acceptance criteria based on performance.

The submission is for an expanded labeling (additional indications for use), and the key argument for substantial equivalence is that the technology of the device itself is identical to the previously cleared predicate device. Therefore, no new performance testing or clinical studies were conducted to prove the device meets new acceptance criteria for its core technical performance. Instead, the "study" proving its acceptance is the demonstration that the expanded indications are supported by existing clinical data and that the device remains safe and effective for these new uses, given its proven performance characteristics.

Here's how to break down the information based on your request, focusing on the expanded indications rather than new hardware performance metrics:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission based on substantial equivalence for expanded indications and not a new device with novel performance criteria, the "acceptance criteria" are implicitly tied to demonstrating that the device is as safe and effective as a legally marketed predicate for the new indications.

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

The "test set" in this context refers to the clinical data used to support the expanded indications, as no new hardware performance tests were conducted.

• Sample Size:
  • Hemicrania Continua: 19 patients across various clinical audits and case series/case reports.
  • Paroxysmal Hemicrania: 14 patients across various clinical audits and case series/case reports.
• Data Provenance: The document does not explicitly state the country of origin for the clinical audits and case series/reports. The references include publications in international journals (e.g., Cephalalgia, Headache, J Neurol Neurosurg Psychiatry, J Headache Pain, JAMA Neurol), suggesting a multi-national or at least broader clinical context. The data is presented as a combination of extrapolated data from randomized controlled trials (RCTs) (for cluster headache, DEN150048 and K182369) and retrospective clinical audits and case series/case reports.

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

• The document does not specify the number of experts or their qualifications involved in establishing the "ground truth" for the case series/audits. It refers to published literature (references 5-10) which would inherently involve clinical diagnoses made by medical professionals (neurologists, headache specialists). The diagnoses of hemicrania continua and paroxysmal hemicrania themselves serve as the "ground truth" for these conditions, and their treatment response to nVNS is observed.

4. Adjudication Method for the Test Set

• The document does not describe an explicit adjudication method (e.g., 2+1, 3+1) for the clinical data from the case series/audits. These are real-world observational data and published case series, where patient outcomes are typically evaluated by the treating clinician(s) and potentially reviewed by the authors of the respective papers. The RCT data (for cluster headache) would have had their own internal adjudication processes, but these details are not provided here as the data is "extrapolated."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This device is a direct treatment device, not an AI-assisted diagnostic tool for human readers. Therefore, this type of study is not applicable.

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

• This is a medical device for direct patient treatment, not a diagnostic algorithm. Therefore, "standalone performance" in the context of an algorithm or AI is not applicable. The device itself performs the function (nerve stimulation).

7. The Type of Ground Truth Used

• The ground truth for the expanded indications (hemicrania continua and paroxysmal hemicrania) is based on clinical diagnoses of these conditions and patient-reported (or clinician-observed) outcomes reflecting "clinically meaningful benefits" from nVNS therapy (e.g., decreases in pain severity, reductions in frequency/severity/duration of attacks). This is essentially outcomes data from real-world clinical experience and existing published literature.

8. The Sample Size for the Training Set

• This submission describes a medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable to this 510(k) submission. The device's design and functionality were established through prior development and clearance (K203546).

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

• As explained above, there is no "training set" in the context of an AI/ML device. The "ground truth" for the device's original design and safety/effectiveness (as detailed in the predicate K203546) would have been established through a combination of engineering validation, non-clinical testing, and clinical studies for the original indications. The current submission simply leverages that established ground truth and applies it to new, similar indications based on existing clinical evidence.

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