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510(k) Data Aggregation

    K Number
    DEN180041
    Device Name
    Monarch eTNS System
    Manufacturer
    NeuroSigma, Inc
    Date Cleared
    2019-04-19

    (263 days)

    Product Code
    QGL,OGL
    Regulation Number
    882.5898
    Type
    Direct
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Monarch external Trigeminal Nerve Stimulation (eTNS) System is indicated for treatment of pediatric Attention Deficit Hyperactivity Disorder as a monotherapy in patients ages 7 through 12 years old who are not currently taking prescription ADHD medications. The device is used for patient treatment by prescription only and is intended to be used in the home under the supervision of a caregiver during periods of sleep.

    Device Description

    The Monarch external Trigeminal Nerve Stimulation (eTNS) System is a non-invasive device that uses electrical signals to therapeutically stimulate the Trigeminal nerve. The primary components of the device are:

    • The Monarch external pulse generator
    • The Monarch NS-2 external (cutaneous) electrical patches, which are single use disposable patches worn on the forehead.

    The device has two primary components A) an external pulse generator approximately the size of a cell phone, and B) the non-invasive electrical patch that patients apply to their forehead to receive therapy.

    AI/ML Overview

    The Monarch eTNS System underwent two clinical studies to establish its effectiveness and safety.

    1. Acceptance Criteria and Reported Device Performance

    The primary acceptance criteria for effectiveness were based on the change in ADHD-IV Rating Scale (ADHD-RS) scores.

    Acceptance Criteria (Implicit from Study 2 Primary Endpoint)Reported Device Performance (Study 2, Active Group vs. Sham)
    Statistically significant improvement in ADHD-IV RS total score in the active group compared to the sham group after 4 weeks of treatment.ADHD-RS Total Score: Active Group: Decreased from 34.1 at baseline to 23.4 at Week 4 (mean change of -10.7). Sham Group: Decreased from 33.7 at baseline to 27.5 at Week 4 (mean change of -6.2). The difference between active and sham groups was clinically meaningful and statistically significant (p < 0.05, though exact p-value for the primary endpoint comparison is not explicitly stated, significance is claimed).
    Demonstration of a clinically meaningful treatment effect.Cohen's d test: Demonstrated a medium effect size in ADHD-RS Total scores. CGI-I Scale: 52% of subjects in the active group improved by one or more points vs. 14% in the sham group (p=0.003 at Week 4).
    Acceptable safety profile with no serious adverse events.Safety: No serious adverse events reported in either study. All reported adverse events were mild to moderate in severity and reversible. Minor side effects included nightmares, headache, frequent urination, increased appetite, skin rash, and teeth clenching (some more prevalent in active group, some in sham or similar). No discontinuations due to these events.

    2. Sample Size and Data Provenance

    Study 1 (eTNS-ADHD01):

    • Test Set Sample Size: 24 subjects initiated treatment (22 completed at least to Week 4 for analysis).
    • Data Provenance: Not explicitly stated, but clinical studies for FDA De Novo requests typically involve US-based participants. The study was open-label.

    Study 2 (eTNS-ADHD02):

    • Test Set Sample Size: 62 subjects enrolled and randomized (32 to active, 30 to sham). 59 subjects completed the 4-week double-blind treatment period (31 in active, 28 in sham). A subset of patients (18 initially) continued in an open-label extension for long-term data.
    • Data Provenance: Not explicitly stated, but the demographics showing a diverse and representative US treatment population suggest a US origin. The study was prospective, randomized, and double-blind, sham-controlled.

    3. Number of Experts and Qualifications for Ground Truth

    The ground truth for the effectiveness endpoints (ADHD-RS and CGI-I) was based on clinical assessments by qualified personnel.

    • Study 1: The pre-specified primary outcome measure was the investigator-completed ADHD-RS. This implies a trained clinical investigator assessed the ADHD-RS. Specific qualifications (e.g., number of years of experience, specific specialty) are not detailed in the provided text, beyond being "investigators."
    • Study 2: The primary endpoint was also the ADHD-IV RS, and the CGI-I was a secondary endpoint. It is implied these were also assessed by clinical investigators. Again, specific qualifications of these experts are not explicitly detailed.

    4. Adjudication Method for the Test Set

    The information provided does not explicitly detail an adjudication method (like 2+1, 3+1, or none) for establishing ground truth for the test sets in either study. The ADHD-RS is an investigator-rated scale, implying a single assessment per participant rather than a consensus approach involving multiple independent raters with subsequent adjudication.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    No MRMC comparative effectiveness study was performed or described. The studies conducted were clinical trials evaluating the device's therapeutic effect on patients, not studies comparing human reader performance with or without AI assistance in diagnostics. Therefore, an effect size of how much human readers improve with AI vs without AI assistance is not applicable here.

    6. Standalone Performance (Algorithm Only)

    The Monarch eTNS System is a medical device for therapy delivery, not a diagnostic algorithm. Therefore, a standalone performance study of an algorithm without human-in-the-loop performance is not applicable to this device. Its performance is measured by its therapeutic effect on patients, as demonstrated in clinical trials.

    7. Type of Ground Truth Used

    The ground truth for the effectiveness of the Monarch eTNS System was based on clinical assessment scales and their interpretation by clinical investigators/experts.

    • Study 1 & 2: The primary effectiveness measure was the ADHD-IV Rating Scale (ADHD-RS) an assessment tool completed by clinicians to quantify ADHD symptoms.
    • Study 1 & 2: Secondary effectiveness measures included the CGI-Improvement Scale (CGI-I), another clinician-rated scale to assess global improvement.
    • Safety: Ground truth for safety was based on the reporting of adverse events by participants and/or caregivers, and their assessment by study investigators.

    8. Sample Size for the Training Set

    The provided document describes clinical trials (eTNS-ADHD01 and eTNS-ADHD02) which are typically used for validation of the device's safety and effectiveness. It does not mention a separate "training set" for an algorithm, as the Monarch eTNS system is a neuromodulation device, not an AI or machine learning diagnostic tool that requires a training set in the conventional sense. The studies serve as the evidence base for its clinical utility.

    9. How Ground Truth for the Training Set Was Established

    As mentioned above, the concept of a "training set" for an algorithm is not applicable to this device. The clinical trials served as the primary evidence collection for evaluating the device's performance, with ground truth established through validated clinical scales administered by investigators.

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