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510(k) Data Aggregation

    K Number
    K970835
    Device Name
    FACE MASK, SURGICAL MASK, NON-STERILE
    Manufacturer
    TUCKER & ASSOCIATES
    Date Cleared
    1997-09-03

    (196 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    K022256
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material.

    Device Description

    FACE MASK, SURGICAL

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for a "Face Mask, Surgical Mask, Non-Sterile." This document does not describe an AI/ML device or its performance criteria.

    Therefore, I cannot provide the requested information, as the input document does not contain details about:

    • Acceptance criteria for an AI/ML device
    • A study demonstrating performance against such criteria
    • Sample sizes for test or training sets
    • Data provenance
    • Ground truth establishment or type
    • Expert qualifications or adjudication methods
    • MRMC studies or standalone algorithm performance.

    The document essentially states that the surgical face mask is substantially equivalent to legally marketed predicate devices and can proceed to market.

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