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510(k) Data Aggregation

    K Number
    K991104
    Device Name
    MICROTOOLS
    Manufacturer
    CONCEPTION TECHNOLOGY, INC.
    Date Cleared
    1999-07-19

    (109 days)

    Product Code
    MQH
    Regulation Number
    884.6130
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Conceptions Technologies' Microtools are used in the laboratory as a microtool to denude, micromanipulate, inject, hold or transfer human gametes or embryos for assisted hatching, ICSI, or other assisted reproduction procedures.

    Device Description

    Microtools

    AI/ML Overview

    The provided text is a 510(k) summary from 1999 for a device called "Microtools" which are described as tools for micromanipulation in assisted reproduction procedures. This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them based on the provided text. The document is a regulatory approval letter and an indications for use statement, not a scientific study report.

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