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510(k) Data Aggregation

    K Number
    K971228
    Device Name
    FEMTEX 100% COTTON TAMPONS
    Manufacturer
    REGU-TECH ASSOC., INC.
    Date Cleared
    1997-04-09

    (78 days)

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

    Femtex tampons are menstrual tampons that are inserted into the vagina and used to absorb menstrual fluid.

    Device Description

    Femtex 100% Cotton Tampons are menstrual tampons used to absorb menstrual fluid. Femtex Tampons will be provided with 2 absorbencies, regular, and super. Femtex 100% Cotton Tampons are made from cotton and, cotton cord and sewing thread. The material used in Femtex tampons are similar to those used in other legally marketed tampons.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (Femtex 100% Cotton Tampons) and does not contain the information requested regarding acceptance criteria, study details, or performance metrics for an AI/ML-driven device.

    The request asks for details about a study that proves a device meets acceptance criteria, specifically in the context of AI/ML performance, ground truth, expert review, and statistical analysis. The provided text is for a physical product (tampons) and focuses on biocompatibility and absorbency by existing testing standards applicable to such devices, not AI/ML.

    Therefore, I cannot fulfill the request based on the provided input. The input does not contain any of the following information:

    • Acceptance Criteria/Reported Device Performance Table: No such table or performance metrics are present.
    • Sample size (test set) and data provenance: Not applicable to this type of device.
    • Number/Qualifications of experts for ground truth: Not applicable.
    • Adjudication method: Not applicable.
    • MRMC comparative effectiveness study: Not applicable.
    • Standalone (algorithm only) performance: Not applicable.
    • Type of ground truth: Not applicable.
    • Sample size (training set): Not applicable.
    • How ground truth for training set was established: Not applicable.
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