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510(k) Data Aggregation

    K Number
    K153224
    Device Name
    VitalStim(R) Plus Electrotherapy System
    Manufacturer
    DJO, LLC
    Date Cleared
    2016-02-17

    (103 days)

    Product Code
    IPF,HCC
    Regulation Number
    890.5850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K070425
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    For VMS™ - VitalStim Waveforms and sEMG Triggered Stimulation.
    Muscle re-education by application of external stimulation to the muscles necessary for pharyngeal contraction

    Device Description

    The VitalStim® Plus Electrotherapy System is a 2 Channel EMG and 4 Channel electrotherapy system used in treating patients with Oropharyngeal Dysphagia and disorders of the head and neck, with Bluetooth connection to PC software.

    AI/ML Overview

    Here's a breakdown of the requested information based on the provided text. It's important to note that this document is a 510(k) summary for a medical device and not a detailed clinical study report for an AI/algorithm-based device. Therefore, many of the requested points, especially those related to AI system validation (e.g., sample size for test datasets, expert ground truth, MRMC studies), are not applicable to this type of submission.

    The document primarily focuses on demonstrating substantial equivalence to a predicate device for an electrotherapy system, mainly through bench testing and technical comparisons, rather than clinical performance studies against a "ground truth" derived from expert consensus or pathology, as would be common for AI-driven diagnostic tools.

    Acceptance Criteria and Device Performance (for an Electrotherapy System)

    Since this is an electrotherapy system and not an AI/algorithm, the "acceptance criteria" are related to safety, electrical performance, and electromagnetic compatibility. The "reported device performance" demonstrates compliance with these standards.

    Table of Acceptance Criteria and Reported Device Performance

    Category / CharacteristicAcceptance Criteria (Standard / Requirement)Reported Device Performance
    Electrical SafetyIEC 60601-1 for basic safety and essential performanceComplied. The device was tested and found to comply with IEC 60601-1.
    EM CompatibilityIEC 60601-1-2 for electromagnetic compatibilityComplied. The device was tested and found to comply with IEC 60601-1-2.
    UsabilityIEC 60601-1-6 for usabilityComplied. The device was tested and found to comply with IEC 60601-1-6.
    Home HealthcareIEC 60601-1-11 for home healthcareComplied. The device was tested and found to comply with IEC 60601-1-11.
    Nerve/Muscle Stim.IEC 60601-2-10 for performance of nerve and muscle stimulatorsComplied. The device was tested and found to comply with IEC 60601-2-10.
    FCC RequirementsFCC Part 15 Subpart B:2008 Class BComplied. The device was tested to FCC requirements and found to comply with FCC Part 15 Subpart B:2008 Class B.
    FCC CFR Title 47 Part 15 Subpart CComplied. The device was tested to FCC requirements and found to comply with FCC CFR Title 47 Part 15 Subpart C.
    Software ValidationFDA's guidance document: General Principles of Software Validation, Jan 2002Verified. The device's software was verified in accordance with the requirements, and "software testing demonstrated that the software meets its design requirements."
    Wireless CoexistencePerformance in environment with other 2.4 GHz wireless devices (Bluetooth, Wi-Fi)Met all specified requirements. "The performance of VitalStim® Plus Electrotherapy System was evaluated in an environment with other VitalStim device and with other types of 2.4 GHz wireless devices (Bluetooth and Wi-Fi). The device met all specified requirements."
    Patient Leakage Current<100μA per channelChannel 1-4: <100μA. (This is a technical specification for electrical safety, not a performance outcome from a clinical study.)
    Output CurrentSpecific mA at various Ω for VitalStim™ and VMS™ waveforms (e.g., 25mA at 500Ω)Matches predicate device for most listed impedances. (Minor difference noted for 10000Ω where the new device is 7mA vs predicate's 12mA, but considered acceptable for substantial equivalence).

    Regarding the points typically associated with AI/algorithm-based medical devices (which are largely N/A for this submission):

    1. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

      • N/A. This document describes a traditional electrotherapy device. The "test set" here refers to the units of the device itself undergoing electrical, software, and wireless performance testing, not a dataset of patient images or clinical data for an algorithm. There is no patient data or "test set" in the sense of clinical validation for AI.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

      • N/A. Ground truth for AI systems (like disease presence in images) is not applicable here. The "ground truth" for this device's performance is adherence to electrical and safety standards, which is verified by engineering and testing professionals, not clinical experts for data labeling.

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

      • N/A. Adjudication methods are used to establish ground truth in the context of human interpretation of medical data (e.g., for AI training/testing). This is not relevant for the testing of an electrotherapy device's electrical and safety performance.

    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:

      • N/A. This is not an AI-assisted diagnostic or therapeutic device. It is an electrotherapy device. No MRMC study was conducted or is relevant for this type of device.

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

      • N/A. This is not an algorithm.

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

      • N/A. The "ground truth" for this device's performance relates to its conformance to established engineering, electrical, and safety standards (e.g., IEC, FCC) and its design specifications, not clinical outcomes or diagnoses.

    7. The sample size for the training set:

      • N/A. This device does not use a "training set" in the context of machine learning or AI.

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

      • N/A. Not applicable, as there is no AI training set.
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