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510(k) Data Aggregation

    K Number
    K132490
    Device Name
    SKORE AND MULTIPLE BRANDS
    Manufacturer
    TTK PROTECTIVE DEVICES LIMITED (FORMERLY TTK-LIG L
    Date Cleared
    2014-10-20

    (438 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Type
    Abbreviated
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TTK PROTECTIVE DEVICES LIMITED (FORMERLY TTK-LIG L

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

    SKORE Natural, SKORE Dots Natural, SKORE Bulbous Natural and SKORE Bulbous Dots & Ribs Natural - Male Natural Rubber Latex Condoms are used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

    Device Description

    SKORE Natural, SKORE Dots Natural and SKORE Bulbous Dots & Ribs Natural - Male Natural Rubber Latex Condoms.

    AI/ML Overview

    The provided text is a U.S. Food and Drug Administration (FDA) 510(k) clearance letter for various latex condoms (SKORE Natural, SKORE Dots Natural, SKORE Bulbous Natural, and SKORE Bulbous Dots & Ribs Natural).

    This document does not contain any information about acceptance criteria or a study that proves the device meets acceptance criteria.

    The letter is a regulatory clearance document, confirming that the FDA has determined the device to be substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It sets forth the general controls and regulations the manufacturer must comply with.

    Therefore, I cannot provide the requested information, including:

    1. A table of acceptance criteria and reported device performance
    2. Sample sizes for test sets or data provenance
    3. Number of experts or their qualifications for ground truth establishment
    4. Adjudication method
    5. MRMC comparative effectiveness study details or effect size
    6. Standalone performance details
    7. Type of ground truth used
    8. Sample size for the training set
    9. How ground truth for the training set was established
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