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    K Number
    K151170
    Device Name
    Tosama 100% Organic Cotton Menstrual Tampon
    Manufacturer
    TOSAMA D.O.O.
    Date Cleared
    2015-07-02

    (62 days)

    Product Code
    HEB
    Regulation Number
    884.5470
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K130609
    Why did this record match?
    Device Name :

    Tosama 100% Organic Cotton Menstrual Tampon

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

    The Tosama 100% Organic Cotton Menstrual Tampon is intended for insertion into the vagina for the absorption of menstrual or other vaginal discharge.

    Device Description

    The device will be offered as a traditional unscented menstrual 100% organic cotton tampon consisting of an absorbent pledget, a withdrawal cord, and an applicator. The pledget is of the traditional cylindrical, bullet-like shape and the applicator has a standard rounded tip to ease insertion. Each tampon is individually wrapped and packaged in multi-unit containers for retail sale. It will be offered in three absorbencies: Regular, Super, and Super Plus.

    AI/ML Overview

    This document is a 510(k) premarket notification for a menstrual tampon. It is not a study about an AI-powered medical device. Therefore, it does not contain the information required to answer your request regarding acceptance criteria and a study proving a device meets them for an AI device.

    The document discusses the substantial equivalence of the "Tosama 100% Organic Cotton Menstrual Tampon" to a predicate device (Naturalena 100% Cotton Tampon). It outlines the general safety and effectiveness of the traditional medical device through non-clinical testing.

    Here's why the requested information cannot be provided from this document:

    1. Nature of the Device: The device described is a physical menstrual tampon, not an AI-powered software or system.
    2. Type of Study: The document refers to "non-clinical data" and "testing" (chemical, microbiological, biocompatibility, efficacy) for the tampon, which are standard for physical medical devices to demonstrate safety and effectiveness. It does not describe a clinical study of an AI algorithm's performance.
    3. Missing AI-Specific Information: There is no mention of algorithms, machine learning, AI assistance, human readers, ground truth establishment by experts, or training/test sets in the context of AI.

    The requested information is specific to the development and validation of AI/ML-based medical devices, which are not covered by this submission for a menstrual tampon.

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