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510(k) Data Aggregation

    K Number
    K162746
    Device Name
    Ontex and other proprietary names
    Manufacturer
    ONTEX BVBA
    Date Cleared
    2017-03-03

    (154 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K090819
    Predicate For
    K223883
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The W long plastic applicator Tampons are inserted into the vagina to absorb menstrual discharge.

    Device Description

    The W long plastic applicator Tampons are conventional unscented menstrual tampons consisting of an absorbent pledget and an applicator. The pledget is made of organic cotton. The applicator is in polyethylene and of full size (long). The pledget has a W wadding design. The Tampons are available in regular and super absorbencies.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device, specifically tampons. It does not describe an acceptance criteria or a study that proves a device (like an AI/ML algorithm) meets acceptance criteria.

    The document is a regulatory submission to the FDA to demonstrate that a new device ("W long plastic applicator Tampons") is substantially equivalent to a legally marketed predicate device ("Ontex Tampon (Unscented)"). This process is for conventional medical devices, not AI/ML systems.

    Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sizes, or how training ground truth was established) from this document because it pertains to a different type of device and regulatory approval process.

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