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510(k) Data Aggregation

    K Number
    K993396
    Device Name
    REMED MALE EXTRA STRENGTH CONDOM PREVENTOR, LUCKY BOY, SUMMIT
    Manufacturer
    REMED PHARMA
    Date Cleared
    2000-02-15

    (130 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Type
    Abbreviated
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Remed Preventor Extra Strength Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Extra Strength condom is a parallel sided, extra strong, plain surfaced condom with no color additives. It is used for contraception and to help prevent the transmission of sexually transmitted diseases.

    Device Description

    The Remed Preventor Extra Strength Condom is made of a natural rubber latex sheath, which completely covers the penis with a closely fitted membrane. The Preventor Extra Strength condom is a parallel sided, extra strong, plain surfaced condom with no color additives.

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a medical device: Remed Pharma Male Latex Condom (Extra Strength). It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered medical device. This letter is for a traditional medical device (condom) and primarily addresses regulatory clearance based on substantial equivalence to a predicate device.

    Therefore, I cannot extract the requested information based on the provided text. The document does not describe:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Number or qualifications of experts for ground truth.
    4. Adjudication method for a test set.
    5. A multi-reader multi-case (MRMC) comparative effectiveness study, or effect size with AI assistance.
    6. Standalone algorithm performance.
    7. Type of ground truth used (e.g., pathology, outcomes data).
    8. Sample size for a training set.
    9. How ground truth for a training set was established.
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