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510(k) Data Aggregation

    K Number
    K983320
    Device Name
    ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS
    Manufacturer
    SURETEX PROPHYLACTICS (INDIA) LTD.
    Date Cleared
    1998-12-11

    (81 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS

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

    The intended use of this condom is for contraception and prophylactic purposes (preventing transmission of venereal disease).

    Device Description

    A condom with silicone lubricant is a sheath which covers the penis with a closely fitted membrane

    AI/ML Overview

    The provided text describes a 510(k) submission for latex condoms and does not contain information about an AI/ML powered medical device. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, ground truth, or AI/MRMC specific information.

    The document is a traditional 510(k) summary for a physical medical device (condoms), comparing it to predicate devices based on adherence to voluntary standards and physical testing, and explicitly states "Discussion of clinical tests performed: Not applicable."

    As such, I cannot provide a table of acceptance criteria and device performance in the context of an AI/ML device, nor address sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC/standalone study details.

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