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510(k) Data Aggregation

    K Number
    K183189
    Device Name
    Ultra OTC Facial Toning System
    Manufacturer
    Micro Current Technology, Inc.
    Date Cleared
    2019-04-17

    (149 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Ultra OTC Facial Toning System

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the text provided, I cannot fulfill your request. The document you provided is an FDA medical device clearance letter for a "Ultra OTC Facial Toning System," which is classified as a "Transcutaneous Electrical Nerve Stimulator For Pain Relief."

    This document only covers the regulatory clearance of a physical medical device. It does not contain any information about:

    1. Acceptance criteria for an AI/software device.
    2. A study that proves a device meets acceptance criteria related to AI/software performance.
    3. Specifics of test sets, training sets, ground truth establishment, or expert involvement in relation to AI/software performance.

    Therefore, I cannot extract the information needed to populate the table or answer the questions about the study design, as this information is not present in the provided text.

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