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510(k) Data Aggregation

    K Number
    K210101
    Device Name
    American-Made Surgical Mask
    Manufacturer
    Armbrust Inc.
    Date Cleared
    2022-01-26

    (377 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Abbreviated
    Panel
    General Hospital
    Reference & Predicate Devices
    K111402
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Armbrust American made Surgical Mask, model AA-US-SURGICAL-01 is intended to be worn by adults to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material within a professional healthcare environment. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile. For adult use.

    Device Description

    The USA-Made Surgical Mask, model number AA-US-SURGICAL-01, is an adult sized surgical mask with earloops that is designed to cover the user's nose and mouth and provides a physical barrier to fluids and particulate materials. The USA-Made Surgical Mask is composed of threelayers and features flat pleats. The three layers are comprised of a blue in color fluid resistant polypropylene spunbond (outer layer), electrostatically charged polypropylene meltblown layer for filtration (middle layer), and an additional fluid resistant polypropylene spunbond (inner layer). A malleable nose wire is used in the top of the mask to achieve a proper fit for individuals. The USA-Made Surgical Mask is a single use, disposable device that is provided non-sterile. The surgical mask conforms to ASTM F2100-19, providing a level 3 barrier.

    AI/ML Overview

    The provided document is a 510(k) summary for a surgical mask (Armbrust American Made Surgical Mask, model AA-US-SURGICAL-01). It outlines the device's technical specifications and performance testing results to demonstrate substantial equivalence to a predicate device, rather than a study proving an AI/ML medical device meets acceptance criteria.

    Therefore, many of the requested details about acceptance criteria and study design for an AI/ML clinical study (e.g., sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this document. This document describes the physical and performance characteristics of a surgical mask, not the performance of an algorithm.

    However, I can extract the acceptance criteria and performance data for the surgical mask based on the provided tables.

    Acceptance Criteria and Device Performance (Surgical Mask)

    Item TestedTest MethodPurposeAcceptance CriteriaReported Device Performance
    AA-US-SURGICAL-01ASTM F1862Fluid Resistance to Synthetic Blood160 mmHgNo penetration at 160 mmHg
    AA-US-SURGICAL-01ASTM F2299Particulate Filtration Efficiency>98%Average 99.48%
    AA-US-SURGICAL-01ASTM F2101Bacterial Filtration Efficiency>98%Average 99.4%
    AA-US-SURGICAL-01ASTM F2100Differential Pressure<5mmH2OAverage 4.7mm H2O
    AA-US-SURGICAL-01CPSC CS-191-53 (16 CFR 1610)FlammabilityClass 1IBE, Class 1
    AA-US-SURGICAL-01ISO 10993-5CytotoxicityNo signs of ToxicityGrade 0, Non-Cytotoxic. PASS.
    AA-US-SURGICAL-01ISO 10993-10Intracutaneous IrritationNegligible signs of irritationNon-irritant. PASS.
    AA-US-SURGICAL-01ISO 10993-10Maximization SensitizationNegligible signs of sensitizationNon-sensitizer. PASS.

    Regarding the AI/ML-specific questions, based on the provided document:

    1. Sample size used for the test set and the data provenance: Not applicable. This is for a physical medical device (surgical mask), not an AI/ML algorithm. The performance tests (e.g., fluid resistance, filtration efficiency) are conducted on samples of the mask, not a test set of data.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a surgical mask's physical performance is established by standardized test methods and laboratory measurements, not expert consensus.
    3. Adjudication method: Not applicable.
    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
    6. The type of ground truth used: For the physical mask, ground truth is established by the specified ASTM and CPSC standards and ISO biocompatibility tests, which define the measurable characteristics and acceptance criteria.
    7. The sample size for the training set: Not applicable. There is no training set for a physical device.
    8. How the ground truth for the training set was established: Not applicable.

    In summary, the provided text describes the regulatory clearance of a surgical mask, not an AI/ML-driven medical device, hence information related to AI/ML study design is not present.

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