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510(k) Data Aggregation

    K Number
    K203626
    Device Name
    SureStrip Vitrification Straw, SureLock Vitrification Straw
    Manufacturer
    Allwin Medical Devices, Inc
    Date Cleared
    2021-06-04

    (175 days)

    Product Code
    MQK
    Regulation Number
    884.6160
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SureStrip Virification Straw is cryopreservation storage device. It is intended for use in vitrification procedures to contain and maintain human oocytes (MII), 4-8 cell stage embryos, or blastocyst stage embryos.

    The SureLock Vitrification Straw is a cryopreservation storage device. It is intended for use in vitrification procedures to contain and maintain human oocytes (MII) or 1-cell stage embryos.

    Device Description

    Not Found

    AI/ML Overview

    The provided text includes a 510(k) clearance letter for the SureStrip Vitrification Straw and SureLock Vitrification Straw. However, this document does not contain information regarding acceptance criteria or a study proving the device meets said criteria.

    The document states that the devices are substantially equivalent to legally marketed predicate devices, which means they do not require new performance studies to demonstrate safety and effectiveness for a 510(k) clearance.

    Therefore, I cannot provide the requested information from the given text.

    The information I would have looked for, but is absent, includes:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size and data provenance for a test set.
    3. Details on experts used for ground truth.
    4. Adjudication method.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
    6. If standalone performance was evaluated.
    7. Type of ground truth used.
    8. Sample size and ground truth establishment for a training set.
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