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510(k) Data Aggregation

    K Number
    K963032
    Device Name
    FREE CHOICE
    Manufacturer
    FIRST QUALITY HYGIENIC, INC.
    Date Cleared
    1996-10-11

    (67 days)

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

    FREE CHOICE

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

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

    Device Description

    Femtex Digital Tampons are menstrual tampons used to absorb menstrual fluid. Femtex Digital Tampons will be provided with 3 absorbencies, regular, super and super plus. Femtex Digital Tampons are made from rayon, polyethylene and polypropylene overwrap and cotton cord. There is no applicator

    AI/ML Overview

    It appears that the provided text is a truncated 510(k) summary for a medical device called "Femtex Digital Tampons." This document type primarily focuses on demonstrating substantial equivalence to a predicate device, rather than reporting on clinical performance against specific acceptance criteria for a diagnostic algorithm or device.

    Therefore, the input does not contain the information necessary to answer the questions about:

    1. Acceptance criteria and reported device performance: This document explicitly states "Assessment of Performance Standards: Not Applicable" as it focuses on equivalence rather than meeting pre-defined performance thresholds for analytical or clinical performance (which are more common for diagnostic devices).
    2. Sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, or training set details. These are all concepts related to clinical studies for performance evaluation, which are not detailed in this 510(k) summary for a tampon. The "Non-Clinical Testing" section refers to biocompatibility and absorbency tests, not clinical performance for diagnostic accuracy.

    In summary, the provided content is a 510(k) summary for a tampon, which focuses on material equivalence and non-clinical safety (biocompatibility, irritation, absorbency) rather than performance criteria and studies typically associated with "device meets acceptance criteria" in the context of diagnostic or interventional devices with quantifiable outcomes like sensitivity, specificity, or accuracy.

    To answer your questions, I would need a different type of document, such as a clinical study report or a 510(k) summary for a diagnostic device that includes performance data.

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