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510(k) Data Aggregation

    K Number
    K990719
    Device Name
    EARLOOP FACE MASK
    Manufacturer
    SHUENN BAO SHING CORP.
    Date Cleared
    1999-07-12

    (129 days)

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

    A procedure mask is a disposable device intended for medical .. proses that is worn over the examiner's mouth and nose to prevent contamination between examiner and patient.

    Device Description

    A procedure mask is a disposable device intended for medical .. proses that is worn over the examiner's mouth and nose to prevent contamination between examiner and patient.

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for an "Earloop Face Mask" (also referred to as "Procedure Mask"). This document describes the regulatory clearance of a medical device, not a study evaluating its performance against specific acceptance criteria in the context of an AI/algorithm-driven device.

    Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as it pertains to a different type of evaluation process.

    This document confirms substantial equivalence of the Earloop Face Mask to a predicate device based on its intended use, rather than presenting a performance study with quantitative metrics.

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