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510(k) Data Aggregation

    K Number
    K061491
    Device Name
    LAC-MAC INNERBLOC O.R. GOWN
    Manufacturer
    LAC MAC, LTD.
    Date Cleared
    2006-08-09

    (70 days)

    Product Code
    FYA
    Regulation Number
    878.4040
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LAC-MAC INNERBLOC O.R. GOWN

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

    The Lac-Mac, Limited, InnerBloc® OR Surgical Gowns, based on the RePel Plus™ and GORE® Color Survice of the Art in the cours that are intended to be worn by health care The Lac-Mac, Limited, InnerBiolo OK Surgical Or his asse intended to be wort by health care LP Surgical Goven Pabric materials, are protect both the surgical patient world the operating room personnel from transfer of microorganisms, body filish, and patitulate matterial. For personnel from fransfer of of microolgamisms, "oody" history and processed and packaged.

    Device Description

    Lac-Mac, Limited, InnerBloc™ OR Surgical Gown

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a surgical gown and does not contain information about acceptance criteria or a study proving the device meets them in the context of an AI-powered medical device. The document is a regulatory approval letter from the FDA for a physical product (surgical gown), not a software or AI device.

    Therefore, I cannot provide the requested information. The text does not discuss:

    • Acceptance criteria for an AI device's performance.
    • A study related to AI device performance.
    • Sample sizes for test or training sets.
    • Data provenance.
    • Number or qualifications of experts.
    • Adjudication methods.
    • MRMC studies or effect sizes.
    • Standalone algorithm performance.
    • Type of ground truth.
    • How ground truth was established for a training set.
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