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510(k) Data Aggregation

    K Number
    K202746
    Device Name
    Surgical mask
    Manufacturer
    Ningbo Jingeao Electronics Inc.
    Date Cleared
    2021-08-27

    (343 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K182515
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is 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.

    Device Description

    The surgical mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of galvanized iron wire. The disposable medical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.

    AI/ML Overview

    The provided text describes the acceptance criteria and the results of non-clinical tests for a surgical mask (K202746). It explicitly states that no clinical study was implemented.

    Here's a breakdown of the requested information based on the provided document:

    1. A table of acceptance criteria and the reported device performance

    ItemsAcceptance Criteria (Level 2, ASTM F2100-19)Reported Device Performance (Result)
    Bacterial filtration efficiency (BFE) (%)≥9899.8~99.9%
    Differential pressure (mmH2O/cm²)<6.0 mmH2O/cm²4.0~4.4 mmH2O/cm²
    Sub-micron particulate filtration efficiency at 0.1 micron, % (PFE)≥9899.68~99.83%
    Resistance to penetration by synthetic blood, Minimum pressure in mmHg for pass result29 of 32 test articles passed at 120mmHg32 of 32 test articles passed at 120mmHg
    Flame spreadClass 1Class 1, Non Flammable
    CytotoxicityComply with ISO 10993-5 (non-cytotoxic)Noncytotoxic
    IrritationComply with ISO 10993-10 (non-irritating)Nonirritating
    SensitizationComply with ISO 10993-10 (non-sensitizing)Nonsensitizing

    2. Sample size used for the test set and the data provenance

    • Sample Size for Synthetic Blood Resistance: 32 test articles (masks).
    • Data Provenance: The document doesn't explicitly state the country of origin or whether the tests were retrospective or prospective, but it refers to recognized standards (ASTM F2100-19, ISO 10993-5, ISO 10993-10). These are likely laboratory tests conducted to specific protocols.

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

    • Not applicable. The tests are non-clinical, laboratory-based performance and biocompatibility tests against established standards, not expert-adjudicated clinical outcomes.

    4. Adjudication method for the test set

    • Not applicable. This is not a study requiring human adjudication of results. The acceptance criteria are objective measurements against defined metrics.

    5. 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

    • No. This is a medical device (surgical mask), not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

    • Not applicable. This is a surgical mask, not an algorithm.

    7. The type of ground truth used

    • Objective Performance Standards: The ground truth is established by recognized international and national standards for medical face masks and biocompatibility, specifically:
      • ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
      • ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
      • ISO 10993-10:2010 Biological Evaluation of Medical Device - Part 10: Stimulation and allergic reaction

    8. The sample size for the training set

    • Not applicable. This device does not involve a training set as it is not a machine learning model.

    9. How the ground truth for the training set was established

    • Not applicable. As above, there is no training set for this device.
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