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510(k) Data Aggregation

    K Number
    DEN150048
    Device Name
    gammaCore Non-invasive Vagus Nerve Stimulator
    Manufacturer
    electroCore, LLC
    Date Cleared
    2017-04-14

    (546 days)

    Product Code
    PKR
    Regulation Number
    882.5892
    Type
    Direct
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    Device Description

    The gammaCore Non-invasive Vagus Nerve Stimulator (hereafter referenced as "gammaCore device") is a hand-held portable device (Figure 1) consisting of an outer plastic case, a battery, signal generating and amplifying electronics, a thumbwheel to power on the device and control stimulation intensity (range 0-5 continuous, relative), LED and horn (indicate device status), and a pair of stainless steel skin contact surfaces (referred to as the "stimulation surfaces"). Electrode conductive gel is applied to the electrode surfaces prior to placement on the skin of the neck over the pathway of the vagus nerve.

    AI/ML Overview

    The provided text describes clinical trials for the gammaCore Non-invasive Vagus Nerve Stimulator, but it is not an AI/ML-driven medical device. The focus of the acceptance criteria and the "study that proves the device meets the acceptance criteria" in the prompt implies an AI/ML context, which is not present in the provided document.

    Therefore, many of the requested elements regarding sample size for test sets, data provenance, expert-established ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not applicable to this non-AI/ML device.

    However, I can extract and present the information available regarding the device's performance in clinical trials relative to its intended use and any implied "acceptance criteria" based on the FDA's decision to grant De Novo classification.

    Here's an attempt to structure the available information as requested, while acknowledging the limitations due to the non-AI/ML nature of the device:

    Acceptance Criteria and Device Performance for gammaCore Non-invasive Vagus Nerve Stimulator (Non-AI/ML Device)

    The FDA granted De Novo classification for the gammaCore Non-invasive Vagus Nerve Stimulator based on a clinical comparison of probable risks and benefits to health. The "acceptance criteria" are implied by the clinical endpoints studied and the FDA's determination of probable benefit outweighing probable risks for the indicated population.

    1. Table of Acceptance Criteria (Implied) and Reported Device Performance

    Since this is a non-AI/ML device and not a diagnostic/AI model, the acceptance criteria are not in terms of traditional metrics like sensitivity, specificity, AUC. Instead, for a therapeutic device, acceptance is based on demonstrating a clinically meaningful benefit and an acceptable safety profile. The primary clinical endpoints in the studies serve as the de facto "performance metrics."

    Acceptance Criteria (Implied by Clinical Endpoints)Reported Device Performance (Episodic Cluster Headache Cohort)
    Efficacy: Clinically meaningful improvement in acute pain relief.ACT1 Study (Primary Endpoint): - Response rate (pain 0 or 1 at 15 min, no rescue med at 60 min): 34.2% (nVNS) vs. 10.6% (Sham) (P=0.008, statistically significant in post-hoc subgroup analysis).- Sustained treatment response rate (pain 0 or 1 at 60 min, no rescue med at 60 min): 34.2% (nVNS) vs. 10.6% (Sham). - Subjects who were responders at 15 min for ≥50% of treated attacks: 34.2% (nVNS) vs. 14.9% (Sham) (P=0.04). - Change in duration of attacks from baseline: -14.4 minutes (nVNS) vs. 16.3 minutes (Sham) (P=0.03).
    ACT2 Study (Primary Endpoint): - Attacks pain-free at 15 min (no rescue med at 30 min): 47.5% (nVNS) vs. 6.2% (Sham) (P<0.01, statistically significant).- Percentage of attacks per subject that responded (pain 0 or 1 at 30 min, no rescue med): 58% (nVNS) vs. 25% (Sham).- Change in pain intensity at 15 min: -1.7 (nVNS) vs. -0.6 (Sham).- Subjects who achieved responder status (pain 0 or 1, no rescue med at 30 min) for ≥50% of treated attacks: 64.3% (nVNS) vs. 15.4% (Sham).
    Safety: Acceptable adverse event profile with no unanticipated serious adverse events.ACT1 Study: No device-related serious adverse events. Majority of AEs were mild and transient (e.g., myokymia, neck soreness, application site irritation, sore/dry throat, electrical sensation). ACT2 Study: No device-related serious adverse events. Majority of AEs were mild and transient (similar to ACT1).

    2. Sample Size and Data Provenance

    • ACT1 Study:
      • Total Enrolled: 150 patients with Cluster Headache (101 Episodic CH, 49 Chronic CH).
      • Modified Intent-to-Treat (mITT) Population: 60 subjects in nVNS group, 73 subjects in Sham group (total 133 for primary analysis after excluding those who didn't treat at least one CH attack).
      • Data Provenance: Multi-center clinical trial. Locations not specified beyond "multi-center." Implied prospective.
    • ACT2 Study:
      • Total Enrolled: 102 patients with Cluster Headache (30 Episodic CH, 72 Chronic CH).
      • mITT Population: 48 subjects in nVNS group, 44 subjects in Sham group (for primary endpoint analysis, number of attacks treated was 495 for nVNS and 400 for Sham).
      • Data Provenance: Europe, "postmarket clinical study." Implied prospective.

    3. Number of Experts and Qualifications for Ground Truth

    • Not applicable for a therapeutic device clinical trial. Ground truth here is patient-reported pain scores (0-5 scale) and use of rescue medication, as well as clinician-assessed adverse events. It's not a diagnostic image interpretation scenario where expert readers establish ground truth.
    • Diagnosis of Cluster Headache for study inclusion was based on ICHD-II criteria, established by medical professionals at the study sites.

    4. Adjudication Method for the Test Set

    • Not applicable. The "test set" here refers to the clinical trial participants. The primary outcomes (pain scores, rescue medication use) were assessed directly by the patients and recorded electronically or in diaries. Adverse events were reported by patients and assessed by study investigators/clinicians. No external adjudication panel like in imaging studies.

    5. MRMC Comparative Effectiveness Study

    • Not applicable. This device is a direct therapeutic intervention, not an AI assisting human readers, so an MRMC comparative effectiveness study is not relevant. The studies were direct comparisons of active device vs. sham in patients.

    6. Standalone (Algorithm Only) Performance

    • Not applicable. This is a hardware therapeutic device, not a standalone algorithm.

    7. Type of Ground Truth Used

    • Patient-reported outcomes and clinical assessments.
      • Pain Relief: Patient-reported pain intensity on a 5-point headache pain scale (0: No pain to 4: Very severe pain).
      • Rescue Medication Usage: Patient-reported.
      • Adverse Events: Patient-reported and clinically assessed by study investigators.
      • Diagnosis of CH: Based on ICHD-II criteria by qualified clinicians at study sites.

    8. Sample Size for the Training Set

    • Not applicable. This is not an AI/ML device, so there is no "training set" in the computational sense. The clinical studies were conducted to evaluate the device's efficacy and safety directly.

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

    • Not applicable. (See point 8).

    Summary regarding the context:

    The provided document details the regulatory review of a physical medical device (vagus nerve stimulator) and its supporting clinical trials. The questions in the prompt are highly geared towards AI/ML medical devices, which typically involve algorithms processing data (e.g., images, physiological signals) for diagnostic or predictive purposes, where concepts like "test sets," "training sets," "expert ground truth," and "MRMC studies" are standard. Since the gammaCore device is a therapeutic device that is directly applied to the patient to stimulate a nerve, these AI/ML-specific concepts are largely irrelevant to its evaluation.

    The FDA's "acceptance criteria" for this device were met by demonstrating a probable benefit for the acute treatment of episodic cluster headache (as shown by the statistically significant and clinically meaningful improvements in pain relief in the eCH cohort) and an acceptable risk profile (largely mild and transient adverse events, with no device-related serious adverse events).

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