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510(k) Data Aggregation

    K Number
    K023284
    Device Name
    MIRAGE FULL FACE MASK SERIES 2
    Manufacturer
    RESMED LTD.
    Date Cleared
    2002-11-27

    (56 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K982530,K984428
    Predicate For
    K042403,K063011,K063122,K071149
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Mirage Full Face Mask (FFM) Series 2 is intended for multiple-patient use for adult patients prescribed continuous positive airway pressure (CPAP) and bi-level therapy in hospital, clinic, and home environments.

    Device Description

    Mirage FFM Series 2 is a respiratory mask covering the nose and the mouth. It is a patient interface accessory for use with CPAP and bi-level devices.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and study for the Mirage Full Face Mask (FFM) Series 2:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Explicit or Implied)Reported Device Performance
    Durability/Compatibility with Disinfection Methods: The semi-critical mask components (excluding valve membrane and air tubing) must withstand high-level disinfection for multiple-patient use.The semi-critical mask components can withstand 15 cycles of high-level disinfection. This was validated for: Liquid chemical 3.4% glutaraldehyde solutionLiquid chemical 0.08% peroxyacetic acid and 1% hydrogen peroxideHigh-level thermal disinfection (hot water pasteurization)
    Material Compatibility (Air-path): Materials used for mask components in the air-path should be identical to the predicate device.Materials used for the mask components in the air-path are identical with materials used in the predicate mask Mirage FFM.
    Safety and Effectiveness with New Disinfection Method: The addition of high-level thermal disinfection should not negatively affect safety and effectiveness.The addition of the high-level thermal disinfection method (hot water pasteurization) does not affect safety and effectiveness of the Mirage FFM Series 2.
    Biocompatibility/Material Safety (General): Components should be made of safe materials.The components of Mirage FFM Series 2 are made of the same materials as those of Mirage FFM, with the exception of the headgear and the ports caps. Polyurethane-based fabric for headgear is reported as "more comfortable, allowing the skin to breathe."
    Functionality/Performance (Design Changes): Design changes (e.g., 5-point headgear, luer-lock fittings, elbow retainer shape, cushion sizes) should maintain or improve performance.Enhanced stability (5-point headgear). Improved connection (luer-lock fittings). More user-friendly assembly and disassembly (elbow retainer). Two cushion sizes provide more fitting options. (While not explicitly "performance" in a measurable sense, these are design improvements).

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

    • Sample Size: Not explicitly stated for each disinfection method. The text mentions "The semi-critical mask components can withstand 15 cycles of high-level disinfection." This implies that a sufficient number of components were tested through these cycles to validate the claim. However, the exact number of masks or components constituting the "test set" is not specified.
    • Data Provenance: The study was conducted by ResMed Ltd, an Australian company. The context suggests this was an internal prospective validation study conducted to support the 510(k) submission.

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

    • Not Applicable. This device is a medical mask validated for its disinfection compatibility and material equivalence. The "ground truth" here relates to the physical integrity and continued functionality of the components after disinfection, not a diagnostic interpretation that would involve medical experts establishing a "ground truth" for a test set. The validation would have been performed by engineers, material scientists, or laboratory technicians.

    4. Adjudication Method for the Test Set

    • Not Applicable. As mentioned above, there is no "adjudication" in the sense of expert review for diagnostic accuracy. The assessment would have involved objective measurements or visual inspections following the disinfection cycles to determine if the components met predefined criteria for integrity and functionality.

    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

    • Not Applicable. This is a physical medical device (a mask), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is irrelevant.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

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

    7. The Type of Ground Truth Used

    • The ground truth used was physical validation of device components' integrity and functionality after undergoing specified disinfection cycles, and material composition comparison to the predicate device. This would likely involve:
      • Visual inspection for damage, degradation, or changes.
      • Functional testing of connections, flexibility, and overall fit after disinfection.
      • Material analysis to confirm equivalence or safety.

    8. The Sample Size for the Training Set

    • Not Applicable. This is a physical device, and the evaluation described is a validation study, not a machine learning study that would have a "training set."

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

    • Not Applicable. See point 8.
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