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    K Number
    K211425
    Device Name
    Private Stock Labs Surgical Face Mask
    Manufacturer
    J.K. Private Stock Inc.
    Date Cleared
    2021-10-04

    (150 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K182515
    Predicate For
    K011996
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Private Stock Labs Surgical Face Mask is intended to be worn to protect both the patient and health care personnel from transfer of microorganisms, body fluids and particulate material. Private Stock Labs Surgical Face Mask 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

    PRIVATE STOCK LABS Surgical Face Mask is a single use, three-layer, flat-pleated mask with ear loops and a nose piece. The Surgical Face Mask is manufactured with three layers, of which 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 held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with latex materials, but are made of spandex. The nose piece in the layers of face mask allows the user to fit the face mask around their nose, which is made of malleable polyethylene wire. The surgical mask will be provided in green of outside and white of inside. PRIVATE STOCK LABS Surgical Face Mask is provided non-sterile and for single use.

    AI/ML Overview

    This document describes the non-clinical testing performed for the Private Stock Labs Surgical Face Mask (K211425) to demonstrate substantial equivalence to a predicate device.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Test MethodologyPurposeAcceptance CriteriaReported Device Performance (Result for 3 Lots)
    Fluid Resistance ASTM F1862Evaluate Personal Protective Equipment against fluid penetration, simulating arterial spray.29 out of 32 pass at 120mmHgLot 1: 32 out of 32 pass at 120mmHgLot 2: 32 out of 32 pass at 120mmHgLot 3: 32 out of 32 pass at 120mmHg
    Particulate Filtration Efficiency ASTM F2299Evaluate the non-viable particle filtration efficiency.≥ 98%Lot 1: 99.9% (32 out of 32 pass)Lot 2: 99.9% (32 out of 32 pass)Lot 3: 99.9% (32 out of 32 pass)
    Bacterial Filtration Efficiency ASTM F2101Determine the bacterial filtration efficiency.≥98%Lot 1: 99.9%Lot 2: 99.9%Lot 3: 99.9%
    Differential Pressure (Delta-P) MIL-M-36954CEnsure the pressure drop is not too great for user breathing.< 6.0mmH2O/cm²Lot 1: 5.75 mmH2O/cm²Lot 2: 6.0 mmH2O/cm²Lot 3: 3.94 mmH2O/cm²
    Flammability Class 16CFR 1610Ensure the device does not ignite when exposed to flame.Class 1Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1

    2. Sample Size Used for the Test Set and Data Provenance:

    • Sample Size: For each test (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability Class), 3 non-consecutive lots were tested. Each lot contained 32 samples.
    • Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It describes "non-clinical tests" performed to demonstrate compliance with standards.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

    • This document describes non-clinical performance testing of a physical medical device (surgical face mask) against established industry standards (e.g., ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16CFR 1610). The "ground truth" for these tests are the objective measurements specified by the standards, not expert consensus on qualitative data. Therefore, the concept of "experts establishing ground truth" as it applies to subjective interpretations (like in imaging studies) is not applicable here. The testing would have been performed by laboratory technicians following validated protocols.

    4. Adjudication Method for the Test Set:

    • Not applicable. The tests involve objective measurements against predefined criteria/standards, not subjective assessments requiring adjudication.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

    • Not applicable. This device is a surgical face mask, not an AI or imaging diagnostic device that would involve human readers or comparative effectiveness studies with AI assistance.

    6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

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

    7. Type of Ground Truth Used:

    • The ground truth for these tests is established by objective measurements and adherence to specified performance standards outlined in the referenced ASTM, MIL, and CFR documents. For example, for Bacterial Filtration Efficiency, the "ground truth" is a measured percentage of bacteria filtered, compared against a numerical threshold (≥98%).

    8. Sample Size for the Training Set:

    • Not applicable. This document describes the non-clinical performance testing of a finished medical device according to established standards. There is no "training set" in the context of machine learning or AI algorithms for this type of device.

    9. How the Ground Truth for the Training Set Was Established:

    • Not applicable, as there is no training set mentioned or implied for this device's testing.
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