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510(k) Data Aggregation

    K Number
    K070689
    Device Name
    LG SPERM FREEZING
    Manufacturer
    GENX INTL., INC.
    Date Cleared
    2007-07-03

    (112 days)

    Product Code
    MQL
    Regulation Number
    884.6180
    Type
    Traditional
    Panel
    Obstetrics and Gynecology (OB)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LG SPERM FREEZING

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

    LG Sperm Freezing Medium is intended to be used for the cryopreservation of human sperm.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "LG Sperm Freezing Medium." It is not a study report that describes acceptance criteria and device performance data.

    Therefore, I cannot provide the requested information such as:

    • A table of acceptance criteria and reported device performance
    • Sample size used for the test set and data provenance
    • Number of experts used to establish ground truth and their qualifications
    • Adjudication method
    • MRMC comparative effectiveness study details
    • Standalone performance details
    • Type of ground truth used
    • Sample size for the training set
    • How ground truth for the training set was established

    This document only states that the FDA found the device substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not contain the detailed study information you are looking for.

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