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510(k) Data Aggregation

    K Number
    DEN180059
    Device Name
    Nerivio Migra
    Manufacturer
    Theranica Bioelectronics ltd
    Date Cleared
    2019-05-20

    (195 days)

    Product Code
    QGT,OGT
    Regulation Number
    882.5899
    Type
    Direct
    Panel
    Neurology
    Reference & Predicate Devices
    K130987
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Nerivio Migra is indicated for acute treatment of migraine with or without aura in patients 18 years of age or older who do not have chronic migraine. It is a prescription use, selfadministered device for use in the home environment at the onset of migraine headache or aura.

    Device Description

    The Nerivio Migra is a wearable, battery-powered device that is controlled by a mobile application. The system delivers low energy electrical pulses to the upper arm for 45 minutes per treatment, after which the device turns off automatically.

    The device hardware consists of an armband intended to be worn on a user's upper arm. The armband contains the electronic circuitry and the battery in a plastic storage case as well as two electrodes that are attached to the interior of the armband and placed against the user's skin.

    The device is operated and controlled via software that is installed and run on a user's personal mobile device such as a mobile phone or tablet. The device hardware communicates with the mobile application through a Bluetooth protocol. This mobile application software allows the user to control the stimulation intensity from 0 to 100% (representing intensity levels of 0-40mA), to start or stop the stimulation program, and to view device status such as the device's connection state, a progress bar for stimulation duration, battery level, and user notifications.

    The patient is instructed to adjust the intensity to the strongest stimulation level below the perceived pain level. Treatments with Nerivio Migra are intended to be self-administered by the user immediately after the onset of migraine headache or aura.

    The basic pulse structure is biphasic, with symmetrical interleaving phases and rectangular shape. The amplitude shift signal alternates between a nominal maximum and a nominal minimum of the amplitude signal. The maximal output current is 40mA. The assumed impedance is 1K ohm +/- 500 ohms.

    AI/ML Overview

    The provided text describes the regulatory information, device description, non-clinical/bench studies, and clinical study details for the Nerivio Migra device. It does not contain information about a study that specifically proves the device meets acceptance criteria in the formal sense often used for AI/ML medical devices (e.g., target metrics for sensitivity, specificity, or similar performance measures).

    Instead, the document details a clinical trial designed to demonstrate the safety and effectiveness of the Nerivio Migra device for its intended use compared to a sham device. The "acceptance criteria" here are implicitly tied to the statistical significance and clinical meaningfulness of the primary and secondary endpoints in this clinical trial, as well as satisfactory results from non-clinical testing.

    Based on the provided text, here's a breakdown of the information that aligns with your request, interpreting "acceptance criteria" as the successful demonstration of safety and effectiveness through the described clinical study and non-clinical testing:

    Acceptance Criteria and Device Performance (Interpreted from Clinical Trial Endpoints and Non-Clinical Testing)

    Acceptance Criteria (Implicit from Study Endpoints and Non-Clinical Success)Reported Device Performance (Active Group vs. Sham/Control)
    Non-Clinical Performance: Device performs as intended under anticipated conditions of use (electrical stimulation characterization, impedance monitoring, electrode performance).Met: "Results demonstrated that the system meets specifications." Electrode testing "passed all testing."
    Biocompatibility: Patient-contacting components are biocompatible.Met: Evaluated per ISO 10993-1 and FDA guidance; "All results demonstrated acceptable performance."
    EMC/Electrical Safety: Demonstrated electromagnetic compatibility and electrical, mechanical, and thermal safety.Met: Compliant with IEC 60601-1-2, AAMI/ANSI ES60601-1, IEC 60601-1-11, IEC 60601-2-10.
    Software Performance: Software verification, validation, and hazard analysis performed for "Moderate" level of concern.Met: "Submission contained all elements…adequate documentation…verification and validation (V&V) testing…satisfactory results."
    Primary Effectiveness Endpoint: Percentage of participants reporting a reduction in pain level (severe/moderate to mild/no, or mild to no) within 2 hours of treatment (without rescue medication) is statistically significantly better than sham.Met: Active: 66.7% (66/99) vs. Sham: 38.8% (40/103) in mITT set. Therapeutic gain 27.9%; p-value <0.0001. Clinically significant.
    Secondary Effectiveness Endpoint 1: Proportion of participants achieving 2 hours of Most Bothersome Symptom (MBS) relief is statistically significantly better than sham.Met: Active: 46.3% (44/95) vs. Sham: 22.2% (22/99) in mITT set. Therapeutic gain 24.3%; p=0.0008. Clinically significant.
    Secondary Effectiveness Endpoint 2: Proportion of participants achieving both pain reduction and MBS relief at 2 hours post-treatment is statistically significantly better than sham.Met: Active: 40.0% (38/95) vs. Sham: 15.2% (15/99) in mITT set. Therapeutic gain 25%; p=0.0004. Clinically significant.
    Secondary Effectiveness Endpoint 3: Proportion of participants achieving MBS disappearance at 2 hours post-treatment is statistically significantly better than sham.Not Met: Active: 40.7% (33/81) vs. Sham: 36.4% (32/88) in mITT set. Therapeutic gain 3.6%; p=0.5590. Not statistically or clinically significant.
    Secondary Effectiveness Endpoint 4: Proportion of participants achieving pain-free status at 2 hours post-treatment is statistically significantly better than sham.Met: Active: 37.4% (37/99) vs. Sham: 18.4% (19/103) in mITT set. Therapeutic gain 19.1%; p=0.0036. Clinically significant.
    Safety: Device-related adverse event rates are low and comparable between active and sham groups, with no serious or unanticipated adverse events.Met: Incidence of device-related AEs was low (3.6%) and similar between groups (Active: 4.8%; Sham: 2.4%; p=0.4998). All were mild, resolved, and required no treatment. No serious AEs reported.
    Labeling Sufficiency: Labeling meets 21 CFR 801.109 requirements including IFU, technical parameters, shelf-life, cleaning, EMC, etc.Met: "The labeling is sufficient and meets the requirements of 21 CFR 801.109."

    Study Details:

    1. Sample sizes used for the test set and the data provenance:

      • Test Set (Clinical Study):
        • Randomized Participants: 252 (126 active group, 126 sham group)
        • mITT (Modified Intent to Treat) analysis set (primary effectiveness analysis, excluding run-in and adhering to 1hr onset/2hr assessment): 202 participants (99 active, 103 sham).
        • PP (Per-protocol) analysis set: 197 participants (98 active, 99 sham).
        • ITT (Intent to Treat) analysis set: 203 participants (99 active, 104 sham).
      • Data Provenance: Prospective, multi-center, randomized, double-blind, sham-controlled study. The text does not explicitly state the country of origin for the clinical data; however, the contact information for the manufacturer is in Israel.

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

      • This device is not an AI/ML device that requires "ground truth" derived from expert image interpretation or pathology. Its effectiveness is measured by patient-reported outcomes (pain level, MBS relief, etc.) directly. Therefore, this question is not applicable in the context of this device's clinical study design. The "ground truth" for effectiveness is the patient's subjective experience reported at specific time points.

    3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

      • Not applicable as this is a patient-reported outcome study, not a study involving expert adjudication of findings (e.g., radiology reads).

    4. 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:

      • Not applicable. This is not an AI/ML device assisting human readers. It's a therapeutic device for direct patient use.

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

      • Not applicable. This is a direct patient-use therapeutic device.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

      • Outcomes Data: Patient-reported outcomes (pain scores, MBS status) at specified time points post-treatment. This is the "ground truth" for evaluating the device's effectiveness.

    7. The sample size for the training set:

      • Not applicable. This is not an AI/ML device requiring a training set in the conventional sense. The device delivers electrical stimulation.

    8. How the ground truth for the training set was established:

      • Not applicable. (See #7).
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