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510(k) Data Aggregation

    K Number
    K211631
    Device Name
    Surgical Face Mask
    Manufacturer
    Macheng Thimble Technology Investment Co., Ltd
    Date Cleared
    2021-08-18

    (83 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K203426
    Why did this record match?
    Applicant Name (Manufacturer) :

    Macheng Thimble Technology Investment Co., Ltd

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

    The Surgical Face Masks are 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 a single use, disposable device(s), provided non-sterile.

    Device Description

    The Surgical Face Masks are blue, flat pleated masks with ear loops to hold the device in place over the user's mouth and nose and a nose piece to fit the mask to the face. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are polyester. They are not made with natural rubber latex. The nose piece contained in the proposed device(s) is in the layers of face mask and is made of malleable aluminum wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.

    AI/ML Overview

    The provided text is a 510(k) Summary for a Surgical Face Mask. This type of document is for demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of technical specifications, rather than clinical studies proving a specific performance metric against a disease outcome or a human-AI comparative effectiveness study for an AI-based medical device.

    Therefore, many of the requested points related to AI/MRMC studies, ground truth establishment, expert consensus, and human reader performance are not applicable to this submission. This document focuses on the physical and performance characteristics of a surgical face mask.

    Here's an analysis based on the provided document:

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria for this medical device (surgical face mask) are based on established international and national standards for material performance and safety, primarily
    ASTM F2100 for medical face mask performance, and ISO 10993 for biocompatibility.

    Table of Acceptance Criteria and Reported Device Performance:

    Test MethodPurposeAcceptance CriteriaReported Device Performance
    Biocompatibility Testing (ISO 10993)
    CytotoxicityTo demonstrate the biocompatibility of the subject device.Non-CytotoxicPASS: Under the conditions of the study, the device is non-cytotoxic.
    IrritationTo demonstrate the biocompatibility of the subject device.Non-IrritatingPASS: Under the conditions of the study, the device is non-irritating.
    SensitizationTo demonstrate the biocompatibility of the subject device.Non-SensitizingPASS: Under the conditions of the study, the device is non-sensitizing.
    Performance Testing (ASTM F2100, etc.)
    Fluid Resistance ASTM F1862To demonstrate the functionality of the subject device.For Level 2: 29 out of 32 pass at 120 mmHg. For Level 3: 29 out of 32 pass at 160 mmHg.PASS: 32 out of 32 per lot pass at 120 mmHg (3 non-consecutive lots tested).32 out of 32 per lot pass at 160 mmHg (2 non-consecutive lots tested).30 out of 32 per lot pass at 160 mmHg (1 lot tested).(This indicates the device meets both Level 2 and Level 3 fluid resistance requirements, although it's categorized as Level 2 & 3 in the summary and compared to a Level 2 predicate).
    Particulate Filtration Efficiency ASTM F2299To demonstrate the functionality of the subject device.≥ 98%PASS: 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.79%Lot2: 99.58%Lot3: 99.6%
    Bacterial Filtration Efficiency ASTM F2101To demonstrate the functionality of the subject device.≥ 98%PASS: 3 non-consecutive lots tested, using a sample size of 32/lot. Lot1: 99.56%Lot2: 99.9%Lot3: 99.84%
    Differential Pressure (Delta P) EN 14683 Annex CTo demonstrate the functionality of the subject device.Lot1: 5.2 mmH2O/cm²Lot2: 3.8 mmH2O/cm²Lot3: 3.8 mmH2O/cm²
    Flammability 16 CFR 1610To demonstrate the functionality of the subject device.Class 1PASS: 3 non-consecutive lots tested, using a sample size of 32/lot. Class 1.

    Study Details:

    1. Sample sizes used for the test set and the data provenance:

      • For biocompatibility tests (Cytotoxicity, Irritation, Sensitization), specific sample sizes are not explicitly stated as numerical values (e.g., number of masks or subjects), but the results indicate that the tests were performed sufficiently to declare "PASS" for the acceptance criteria.
      • For performance tests (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Differential Pressure, Flammability), the sample size for each lot tested was 32 units.
      • Data Provenance: The tests were non-clinical, laboratory-based tests performed by the manufacturer, Macheng Thimble Technology Investment Co., Ltd, based in Hubei Province, China. The document does not specify whether the data is retrospective or prospective, as these terms typically apply to clinical studies using patient data. These are results from product testing.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • This question is not applicable. The "ground truth" for this type of device is established by the specified performance standards (e.g., ASTM, ISO, EN). There is no "truth" established by human experts in the context of interpreting medical images or making diagnoses. The tests performed are objective, quantitative measurements.

    3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

      • Not applicable. Adjudication methods are relevant for studies involving human interpretation and consensus (e.g., in clinical trials or image reading studies). This submission relies on objective laboratory test results.

    4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

      • Not applicable. This is a physical product (surgical face mask), not an AI-based diagnostic or imaging device. Therefore, MRMC studies are irrelevant.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

      • Not applicable. This is a physical product, not an algorithm.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

      • The "ground truth" or standard for compliance is defined by the acceptance criteria specified in recognized industry standards (ASTM F1862, ASTM F2299, ASTM F2101, EN 14683 Annex C, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These are objective, measurable parameters.

    7. The sample size for the training set:

      • Not applicable. This is not an AI/machine learning device that requires a training set. The device is a manufactured product tested against established standards.

    8. How the ground truth for the training set was established:

      • Not applicable, as there is no training set for this type of device.
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