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510(k) Data Aggregation

    K Number
    K013086
    Device Name
    WET LIGHT PERSONAL MOISTURIZER
    Manufacturer
    TRIGG LABORATORIES, INC.
    Date Cleared
    2001-12-13

    (90 days)

    Product Code
    HIS
    Regulation Number
    884.5300
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    K013060
    Why did this record match?
    Device Name :

    WET LIGHT PERSONAL MOISTURIZER

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

    WET® Light Personal Moisturizer is intended for which Bight refections. It is used to supplement over the counter abouther aginal area to enhance personal morscure in the vaguer used for lubricating sexual preasure. There easy insertion of rectal thermometers, tampons, douche and enema nozzles.

    Device Description

    Not Found

    AI/ML Overview

    The provided text primarily consists of a 510(k) clearance letter from the FDA for the "WET® Light Personal Moisturizer" and "WET® Flavored Personal Moistures (5 Flavors)". This document focuses on the regulatory approval process and does not contain information about acceptance criteria or a study proving that the device meets those criteria.

    Therefore, I cannot provide the requested information as the input document does not contain details about:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method for a test set.
    5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
    6. Standalone device performance study.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    The document is a regulatory approval letter based on "substantial equivalence" to legally marketed predicate devices, not a scientific study report demonstrating performance against specific acceptance criteria.

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