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510(k) Data Aggregation

    K Number
    K092918
    Device Name
    PARI VIOS
    Manufacturer
    PARI RESPIRATORY EQUIPMENT, INC.
    Date Cleared
    2010-02-04

    (135 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K061381,K002862
    Why did this record match?
    Device Name :

    PARI VIOS

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

    The PARI Vios is a tabletop, AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The PARI Vios is intended for adult and pediatric patients for use in hospital, clinic, or home environments.

    Device Description

    The PARI Vios nebulizer compressor is a small, lightweight AC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The device is non-sterile and prescriptionuse only.

    AI/ML Overview

    The provided documentation describes the PARI Vios nebulizer compressor, but it does not contain information related to acceptance criteria for an AI/ML powered device or a study involving such a device.

    Instead, it's a 510(k) summary for a medical device (a nebulizer compressor) that compares its performance to predicate devices. The "performance" mentioned refers to physical characteristics of the nebulizer compressor itself, not the performance of an algorithm or AI.

    Therefore, I cannot provide answers to the requested categories (acceptance criteria, sample sizes, expert qualifications, adjudication, MRMC, standalone, ground truth, training set) as they are relevant to AI/ML device studies, which are not detailed in this submission.

    Here's a breakdown of what is provided, as it relates to the general concept of device performance:

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

    The document doesn't explicitly state "acceptance criteria" with numerical targets. Instead, it states that the PARI Vios's performance is "comparable to the predicate devices" for the following metrics:

    Acceptance Criteria (Implied: Comparable to Predicate)Reported Device Performance (PARI Vios)
    Total Output Rate (TOR)Comparable to the predicate devices
    MMD (Mass Median Diameter)Comparable to the predicate devices
    Volume %
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