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gammaCore Sapphire (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for:

• · The preventive treatment of migraine headache in adolescent (age 12 and older) and adult patients.
• · The acute treatment of pain associated with migraine headache in adolescent (age 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.

The gammaCore Sapphire (gammaCore) is a multiuse, 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 "clam shell" 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 provided text describes a 510(k) summary for the gammaCore Sapphire device, which is an external vagal nerve stimulator for headache. This submission seeks to expand the indications for use to include the adolescent population for the preventive and acute treatment of migraine headache.

Based on the information provided, here's a breakdown regarding acceptance criteria and supporting studies:

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

   The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) because this is a 510(k) submission for an expanded indication of an already cleared physical medical device, not a new AI/ML-driven diagnostic or prognostic device. The "acceptance criteria" in this context are related to demonstrating substantial equivalence to a predicate device and safety and effectiveness in the new population. The substantial equivalence comparison table (Table 1) acts as the primary "performance" comparison.

   Acceptance Criteria (Implied)	Reported Device Performance (Subject Device vs. Predicate)
   Intended Use	Same
   Indication for Use	Expanded to adolescents (age 12+) for preventive and acute migraine treatment. Supported by extrapolation from adult data and a small adolescent study.
   Rx vs OTC	No change (Prescription use)
   Treatment Protocol for Migraine (Acute & Preventive)	No change compared to adults (same 120-second stimulation cycle, number of stimulations, and daily schedule)
   Patient-Contacting Materials	No change (SS, ABS-PC, SignaGel electrode gel)
   Electrical Classification	No change (UL 60601-1 Class III Type BF Applied Part)
   Waveform/Frequency	No change (Sinusoidal wave, symmetrical biphasic 5000-Hz pulses at 25 Hz)
   Maximum Output	No change (30V, 60 mA peak)
   Load Impedance	No change (450-550 ohms)
   Power Supply	No change (3V LiFePo4 battery)
   Service Life	No change (3 Years from date of manufacture)
   Controls	No change (Control slide)
   Output Regulation	No change (Device software and control slide)
   Device Status Display	Differences in user interface that do not impact safety or effectiveness.
   Battery Charger	No change (Qi-compatible wireless charger in clam shell storage case)
   RFID Refill/Reload Capability	No change (Allows refilling/reloading)
   Device Diagnostics (Bluetooth)	No change (Provides diagnostics for manufacturer)
   Alarm Signals	No change (Start-up, Session complete, Errors/depleted battery, No doses left, Expired/no days left, Low battery, Reloading error, Card error)
   Display/Message	No change to core output display, minor user interface differences considered not to impact safety/effectiveness.

2. Sample sizes used for the test set and the data provenance

   For the expansion of indications to adolescents, the primary "test set" for safety and effectiveness relied heavily on:

   • Extrapolation from adult clinical data: This is clearly stated, meaning the adult data from prior studies (PRESTO, PREMIUM, EVENT) served as a large part of the basis.
   • Small adolescent study: "a small study was performed evaluating the use of gamma Core Sapphire in the acute treatment of migraine in adolescent population. As described in Grazzi et al¹, in nine (9) adolescents, 46.8% of treated migraine attacks were considered successfully treated and did not require any rescue medication."
   • Sample size for adolescent study: 9 adolescents.
   • Data provenance: The Grazzi et al. study is a published peer-reviewed paper (Neurol Sci. 2017 May). The document does not specify the country of origin for the Grazzi study, but typically these are international clinical trials. It is a prospective study as it evaluates the use in a group of adolescents.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

   This information is not provided in the 510(k) summary. For a device like nVNS, the efficacy is typically self-reported by patients (e.g., pain reduction, headache freedom) and assessed by clinicians based on established diagnostic criteria for migraine. The Grazzi et al. paper would contain specifics on patient selection and outcome assessment, but that detail is not within this 510(k) summary. Given it's a treatment device, "ground truth" would be clinical outcomes (e.g., headache resolution) rather than an expert-adjudicated label on an image.

4. Adjudication method for the test set

   Not applicable in the context of this device. Adjudication methods like 2+1 or 3+1 are common in image-based AI studies where expert consensus is needed to establish a definitive diagnosis for a test image. Here, clinical outcomes are measured after device use.

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 MRMC comparative effectiveness study was done, as this is not an AI-assisted diagnostic device. It is a physical neuromodulation device. Therefore, no information on human reader improvement with AI assistance is applicable or provided.

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

   Not applicable. The gammaCore Sapphire is a physical device that delivers therapy and is used by a human patient. It does not operate as a standalone algorithm or AI.

7. The type of ground truth used

   The ground truth for the effectiveness of the device in the expanded indication (adolescents) is based on:

   • Clinical Outcomes Data: Self-reported pain relief and resolution of migraine symptoms, as well as the absence of requiring rescue medication. The Grazzi et al. study reported "46.8% of treated migraine attacks were considered successfully treated and did not require any rescue medication."
   • Adult Clinical Trial Results: The prior 510(k)s (K173442, K191830) relied on outcomes from multi-center, randomized, double-blind, sham-controlled clinical studies (PRESTO, PREMIUM, EVENT) for adults.

8. The sample size for the training set

   Not explicitly applicable in the context of this device because it's not an AI/ML algorithm that is "trained" on data in the traditional sense. The device's technological characteristics are fixed. The clinical studies (PRESTO, PREMIUM, EVENT, and the Grazzi et al. study) provide the evidence base that informed the safety and effectiveness, rather than a "training set" for an algorithm. The total sample sizes for these studies are not fully detailed in this 510(k) summary but would be found in the referenced prior 510(k) documents and publications. The adult studies would have had considerably larger sample sizes than the 9 adolescents mentioned.

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

   Again, "training set" and "ground truth" establishment in the AI/ML sense are not directly applicable. The "ground truth" for the effectiveness shown in the supporting clinical studies (for both adults and adolescents) was established through clinical trial methodology:

   • Randomized, double-blind, sham-controlled study designs comparing the device to a sham control.
   • Measurement of defined clinical endpoints, such as pain reduction, headache freedom, and reduction in headache frequency.
   • Reporting of adverse events to assess safety.

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gammaCore Sapphire (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for:

• · 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.
• · The acute treatment of pain associated with migraine headache in adult patients.

The gammaCore Sapphire (gammaCore) is a multiuse, 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 "clam shell" 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 provided documentation describes the gammaCore Sapphire (non-invasive vagus nerve stimulator), which is indicated for:

• 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.
• The acute treatment of pain associated with migraine headache in adult patients.

The information primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining specific acceptance criteria for performance benchmarks against a gold standard for a diagnostic AI device. However, based on the clinical study presented, we can infer a primary efficacy outcome as an "acceptance criteria" and the reported device performance from that study.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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