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510(k) Data Aggregation

    K Number
    K983716
    Device Name
    VITALCARE DISPOSABLE VAGINAL SPECULUM
    Manufacturer
    VITALCARE GROUP, INC.
    Date Cleared
    1998-12-23

    (63 days)

    Product Code
    HIB
    Regulation Number
    884.4530
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VITALCARE DISPOSABLE VAGINAL SPECULUM

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

    A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.

    Device Description

    Disposable Nonmetal Vaginal Speculum

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a VitalCare Disposable Nonmetal Vaginal Speculum, along with its Indications for Use. This type of document is for medical devices and does not contain the kind of information requested about acceptance criteria and studies for AI/software-as-a-medical-device (SaMD) performance.

    Therefore, I cannot extract the requested information from this document. The questions you've asked are specific to the validation of AI algorithms or software, which involves performance metrics like sensitivity, specificity, sample sizes for training/test sets, expert adjudication, and comparative effectiveness studies. This 1998 FDA clearance document for a physical medical device does not provide any of that information.

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