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    K Number
    DEN240076
    Device Name
    Modius Lean
    Manufacturer
    Neurovalens Limited
    Date Cleared
    2025-10-17

    (303 days)

    Product Code
    SFW
    Regulation Number
    N/A
    Type
    Direct
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K232253
    Device Name
    Modius Stress
    Manufacturer
    Neurovalens Limited
    Date Cleared
    2024-03-27

    (243 days)

    Product Code
    QJQ,OJO
    Regulation Number
    882.5800
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K062284,K903014
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Modius Stress is a non-invasive, home-use neurostimulation device that is indicated to treat the symptoms of Generalized Anxiety Disorder in adults aged 22 and older, when used for approximately 4 weeks. Durability of effect after 4 weeks has not been established.

    Device Description

    Modius Stress is a non-invasive transdermal neurostimulation device to treat the symptoms of Generalized Anxiety Disorder. The proposed mechanism of the device is through a technology known as Cranial Electrotherapy Stimulation (CES). It consists of a battery-powered device designed to transcutaneously deliver low-level electrical energy (up to 1.5mA) to the skin behind the ears, over the mastoid processes. The delivery of this neurostimulation is through two self-adhesive electrode pads. These pads are placed on the skin behind each ear (mastoid area). The intensity of the electric pulse can be adjusted up or down by the user. When turned on, the device delivers a small electrical impulse, and adjustments to the stimulation level may be made using the up and down buttons on the device, which are located just above the power button. The device can also be paused by pressing the power button twice. When finished the user removes the device and disposes of the electrode pads after each use. When the device is not being used it can be charged through a micro-USB cable. For safety reasons, it is not possible to recharge the battery while the device is in use in stimulation mode. The key components of the Modius Stress include the Modius Stress device (plastic enclosure and printed circuit board assembly (PCBA), stimulation pads (K210448 and K132588), skin cleansing wipes (K121655) and charging accessories. The PCBA consists of a microcontroller, USB connector, transformer driver, IO expander and EEPROM memory. The embedded software within the device manages overall functionality of the device from Stimulation Control, Power Management, and user interaction (Indication LED and Audio tones).

    AI/ML Overview

    The Modius Stress device is a non-invasive neurostimulation device indicated to treat symptoms of Generalized Anxiety Disorder (GAD) in adults aged 22 and older when used for approximately 4 weeks.

    Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state "acceptance criteria" in a quantitative performance table commonly seen for AI/ML devices (e.g., sensitivity, specificity, AUC thresholds). However, implicitly, the acceptance criteria for the clinical studies focused on demonstrating a significant reduction in GAD-7 scores compared to a sham control.

    Acceptance Criterion (Implicit)Reported Device Performance (Modius Stress)
    Significant reduction in GAD-7 score compared to sham control (primary effectiveness endpoint)India Study (met): Mean GAD-7 score reduction of -7.44 in Modius Stress group vs -2.23 in sham group (p<0.001).UK Study (not statistically significant for primary endpoint): Mean GAD-7 score reduction of -5.41 in Modius Stress group vs -3.96 in sham group (p=0.139).Post-hoc Subgroup Analysis (UK): Mean GAD-7 score reduction of 7.44 in Modius Stress group (baseline GAD-7 ≥ 10) vs 5.36 in sham control.
    Safety profile comparable to sham control (primary safety endpoint)India Study: No causally related adverse events or serious adverse events reported in either group.UK Study: 7 minor adverse events reported (5 in Modius Stress, 2 in sham). No serious adverse events reported.
    Device biocompatibilityPassed ISO 10993-1.
    Electrical safetyComplies with IEC 60601-1.
    Electromagnetic compatibility (EMC)Complies with IEC 60601-1-2.
    UsabilityComplies with IEC 62366.
    Maximum Current & Phase Charge TestingPassed (detailing max current/power output, max phase charge, max current density, max power density).
    System Verification and Validation TestingPassed (hardware and firmware).
    Software Verification and Validation TestingComplies with FDA Guidance, with "moderate" level of concern.

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

    The "test set" refers to the participant groups in the clinical trials.

    • UK Study:
      • Sample Size: 87 eligible participants enrolled (43 Modius Stress, 44 sham control). 84 participants (42 Modius Stress, 42 sham control) were included in the ITT analysis for primary effectiveness and safety. 75 participants (36 Modius Stress, 39 sham control) were included in the complete case analysis.
      • Data Provenance: Prospective, multi-site human clinical trial conducted in the United Kingdom (UK) and Republic of Ireland (ROI) (remote recruitment).
    • India Study:
      • Sample Size: 60 eligible participants enrolled (34 Modius Stress, 26 sham control). All 60 participants were included in the ITT and complete case analyses for both primary effectiveness and safety.
      • Data Provenance: Prospective, human clinical trial conducted in India.

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

    The ground truth in this context is the assessment of Generalized Anxiety Disorder (GAD) symptoms, primarily using the GAD-7 score. The document does not specify the number or qualifications of experts used to establish the "ground truth" for the test set in the traditional sense of medical image annotation or diagnosis. Instead, the GAD-7 scale itself is a validated self-report questionnaire, commonly used in clinical practice and research for screening and measuring the severity of GAD. The study recruited adults with a GAD-7 score of 10 or higher. While medical professionals (e.g., prescribing physicians) are involved in the overall care, the "ground truth" for GAD-7 scores is derived directly from participant self-reporting on this validated instrument.

    4. Adjudication Method for the Test Set

    Not applicable in the context of GAD-7 scores. The GAD-7 is a standardized questionnaire without a need for independent expert adjudication of each score. The studies were double-blinded, meaning neither participants nor the clinical study team knew the device allocation (Modius Stress vs. sham).

    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

    This is not an AI/ML device in the context of image interpretation or diagnostic assistance where MRMC studies are typically performed. The device is a neurostimulation therapy device. Therefore, a MRMC comparative effectiveness study was not done.

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

    The Modius Stress device is a therapeutic neurostimulation device, not an AI algorithm. Its performance is evaluated on its direct effect on physiological conditions, not on its ability to interpret data or provide diagnostic insight. Its usage is standalone in the sense that the device delivers the stimulation (algorithm) without constant human intervention during a session, but it is to be used by a human patient for a therapeutic purpose. The clinical trials evaluated the device's therapeutic effect directly.

    7. The Type of Ground Truth Used

    The primary ground truth used in the clinical studies was the Generalized Anxiety Disorder 7th edition (GAD-7) score, which is a validated self-report questionnaire for assessing GAD symptoms. Participants with a GAD-7 score of 10 or higher were recruited, indicating at least moderate anxiety.

    8. The Sample Size for the Training Set

    The Modius Stress device is a hardware neurostimulation device that applies Cranial Electrotherapy Stimulation (CES) and is not an AI/ML software algorithm that requires a "training set" in the conventional sense. Therefore, there is no training set for an AI algorithm. The device's parameters and design would have been developed based on scientific understanding of CES and prior research (including "general CES summary" referenced in the text), rather than a machine learning training dataset.

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

    As there is no AI/ML algorithm requiring a training set, this question is not applicable. The device's underlying principles for neurostimulation are based on existing knowledge of Cranial Electrotherapy Stimulation (CES).

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