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    K Number
    K071915
    Device Name
    CPAP MASK
    Manufacturer
    ARCIMED LABORATORIES LLC
    Date Cleared
    2008-05-14

    (308 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K063122,K950771,K002465
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A patient interface, face mask, for use with CPAP and bi-level systems used in the treatment of adult (>30 kg) OSA and / or ventilatory support. Two styles (with exhalation port and without exhalation port). Single use only < 24 hours.

    Device Description

    The proposed patient interface face mask incorporates a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use. Adhesive foam to seal to the patient face. One size - medium. Models with and without Integral fixed leak (exhalation) port.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study information based on the provided text, categorized as requested:

    1. Table of Acceptance Criteria and Reported Device Performance

    Feature/MetricAcceptance Criterion (Predicate Device Performance)Reported Device Performance (ARCimed CPAP mask)
    Exhaust Flow RangePressure / Flow (lpm)3 cm H2O / 17.8 lpm10 cm H2O / 31.5 lpm20 cm H2O / 42.6 lpm30 cm H2O / 51.7 lpm40 cm H2O / 60.1 lpm(Based on ResMed Quattro K063122)Pressure / Flow (lpm)3 cm H2O / 19.9 lpm10 cm H2O / 33.3 lpm20 cm H2O / 47.1 lpm30 cm H2O / 58.0 lpm40 cm H2O / 67.8 lpmPass / fail +/- 15% (Implied acceptance within this range of predicate)
    Pressure Drop (Resistance to Flow)ResMed – K0631220.59 cm H2O @ 50 lpm1.2 cm H2O @ 100 lpm0.35 cm H2O @ 50 lpm0.81 cm H2O @ 100 lpm
    CO2 RebreathingResMed – K0631220.25% EtCO2 (Measured change from baseline)0.06% EtCO2 (Measured change from baseline)
    Adhesive SealAdvanced Warming – K950771Offers a tight sealNo performance requirements other than it will remain attached to patient's faceWe are claiming no performance requirements other than the mask will seal and remain attached to the patient's face.
    Vented/Non-vented models (Anti-Asphyxia Valve compatibility)Yes – ResMed – K063122Offer a mask with optional anti-asphyxia valveVented and Non-vented models requires attachment to a circuit with anti-asphyxia valve incorporated demonstrated to activate AAV valve equivalent to predicates. Should be used with AAV with minimum opening pressures of < 3 cm H2O.
    Dead Space203 ml (K063122)91 ml

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

    The provided text does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The data presented appears to be laboratory or bench testing results rather than clinical study data.

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

    The document does not mention the involvement of experts for establishing ground truth for the test set. The reported device performance metrics (exhaust flow, pressure drop, CO2 rebreathing, dead space) are objective physical measurements, likely derived from engineering or laboratory testing. The statement regarding the adhesive seal ("will seal and remain attached to the patient's face") is a functional claim, not an expert-derived ground truth.

    4. Adjudication Method for the Test Set

    As there's no mention of expert involvement or interpretation for the test set, no adjudication method (e.g., 2+1, 3+1) is described or implied. The data seems to be from direct measurements.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

    No. The document describes a comparison of device specifications and performance metrics against predicate devices, not an MRMC study. There is no information about human readers or improvement with AI assistance.

    6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

    N/A. This device is a physical CPAP mask, not an algorithm or AI-powered system. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The performance described is the standalone performance of the physical mask.

    7. The Type of Ground Truth Used

    The ground truth for the performance metrics appears to be objective physical measurements and engineering specifications derived from testing the device itself, and comparison against the established specifications of predicate devices. For example:

    • Exhaust flow: Measured directly.
    • Pressure Drop: Measured directly.
    • CO2 Rebreathing: Measured directly (percentage EtCO2 change from baseline).
    • Dead Space: Measured directly.
    • Adhesive Seal: Functional claim, likely verified through physical testing for adherence.

    There is no mention of expert consensus, pathology, or outcomes data as ground truth.

    8. The Sample Size for the Training Set

    Not Applicable. The device is a physical CPAP mask. There is no AI model or algorithm that requires a "training set" in the context of this submission. The comparison is based on physical and functional equivalence to predicate devices.

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

    Not Applicable. As there is no training set mentioned or implied for this physical device, there is no ground truth established for a training set.

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