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510(k) Data Aggregation

    K Number
    K242968
    Device Name
    Giftlife® Single-Step Medium Plus
    Manufacturer
    Gimbo Medical Technology Shenzhen Co., Ltd.
    Date Cleared
    2024-11-22

    (57 days)

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

    Giftlife**®** Single-Step Medium Plus

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

    Giftlife Single-Step Medium Plus is used for culture of embryos from fertilization to the blastocyst stage.

    Device Description

    Not Found

    AI/ML Overview

    The provided FDA 510(k) clearance letter for the "Giftlife® Single-Step Medium Plus" does not contain information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML device.

    This document is a clearance letter for a medical device (Reproductive media and supplements, specifically for embryo culture), not an AI/ML software as a medical device (SaMD). Therefore, the typical acceptance criteria and study data associated with AI/ML performance metrics (such as sensitivity, specificity, AUC, human reader improvement, etc.) are not present in this type of regulatory submission.

    The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has been determined to be as safe and effective as a previously cleared device. This determination is based on various factors, including design, materials, chemical composition, intended use, and performance characteristics, but these are assessed through methods appropriate to the device type (e.g., chemical analysis, biological assays, sterility testing, stability studies for culture media), rather than AI/ML performance studies.

    Therefore, I cannot fulfill your request for:

    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. MRMC comparative effectiveness study results.
    6. Standalone AI performance.
    7. Type of ground truth (expert consensus, pathology, outcomes data).
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    These elements are specific to the evaluation of AI/ML devices and are not relevant to the clearance of a reproductive culture medium as described in this document.

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