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510(k) Data Aggregation

    K Number
    K201853
    Device Name
    Naton Disposable Surgical Face Mask
    Manufacturer
    Naton Biotechnology (Beijing) Co., Ltd.
    Date Cleared
    2021-04-23

    (291 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

    Naton Disposable Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, There are 4 types of Naton Disposable Surgical Face Mask: Ear Loops B-1, Tie-on B, Tie-on B-1, which are provided sterile.

    Device Description

    Naton Disposable Surgical Face Mask

    AI/ML Overview

    The provided document describes the FDA 510(k) clearance for the Naton Disposable Surgical Face Mask. This document is a regulatory approval letter and an "Indications for Use" statement. It does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria, especially not for an AI/ML medical device.

    The information requested in your prompt (AI/ML device performance, sample sizes, expert qualifications, ground truth, MRMC studies, etc.) is specifically pertinent to the evaluation of AI/ML-based medical devices. The Naton Disposable Surgical Face Mask is a physical product (a Class II surgical apparel), and its testing and approval process would involve different criteria, such as:

    • Fluid resistance: (e.g., synthetic blood penetration)
    • Particulate filtration efficiency (PFE): (how well it filters airborne particles)
    • Bacterial filtration efficiency (BFE): (how well it filters bacteria)
    • Breathability: (differential pressure)
    • Flammability: (spread of flame)
    • Biocompatibility: (skin irritation, sensitization)

    Therefore, I cannot fulfill your request as the provided text does not contain the necessary information about an AI/ML medical device test study.

    If you have a document describing the regulatory submission and study results for an AI/ML medical device, please provide that text, and I would be happy to analyze it according to your requested parameters.

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