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510(k) Data Aggregation

    K Number
    K050425
    Device Name
    AURA-PSG
    Manufacturer
    ASTRO-MED, INC.
    Date Cleared
    2005-10-20

    (244 days)

    Product Code
    OLV,GWQ
    Regulation Number
    882.1400
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K012976,K994142,K021807,K033978
    Why did this record match?
    Device Name :

    AURA-PSG

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

    The AURA-PSG amplifier system is intended for recording routine Electroencephalography (EEG) and Polysomnography (PSG). This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in EEG and/or PSG.

    Device Description

    AURA-PSG is a compact multi-channel amplifier and data acquisition device Aort F OO is a compoephalography (EEG) and polysomnography (PSG) recording applications. It provides for patient safety isolation, signal conditioning, and data sampling. The AURA-PSG amplifier system consists of two major components: the Amplifier Unit and the Base Station. The Amplifier Unit provides connections for electrodes and sensors and is normally worn by the subject in a vest or pocket. The Amplifier and sonoord and to hernRay istation using either a signal cable (tether) or a wireless connection. Both transmit digitized waveform to the Base Station where it is converted to standard network protocols and made available to supporting computers. AURA-PSG can be used for off-line, ambulatory recording. When used in this fashion, power is supplied by a battery and data is stored in internal memory. When the study is complete, data can be sent to a computer for review. The Base Station provides Menu selections for configuring the unit, communicating with the host computer, and implementing an electrode impedance test. It contains an LCD that can display status and other information. Power is supplied to the AURA-PSG Base Station through a rear connector that attaches to a medical-grade requlated power supply (+12 volts DC). The AURA-PSG Amplifier Unit is 5.5 inches x 3.5 inches by 1.0 inches and the AURA-PSG Base Station is approximately 7" x 6" x 2" inches. The Base Station can be attached to a cart arm, mounted on a wall or flat on a tabletop.

    AI/ML Overview

    The provided text is a 510(k) summary for the AURA-PSG EEG Amplifier System, seeking substantial equivalence to predicate devices. It describes the device's intended use and technological characteristics. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

    Therefore, I cannot populate the table or answer the specific questions about performance criteria and study details based on the provided input. The document focuses on regulatory compliance through substantial equivalence to existing devices rather than presenting detailed performance efficacy data.

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