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510(k) Data Aggregation

    K Number
    K172711
    Device Name
    Comet-PLUS
    Manufacturer
    Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK)
    Date Cleared
    2017-11-03

    (56 days)

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

    Comet-PLUS

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

    The Comet-PLUS® is designed for use in the recording of routine EEG, overnight sleep/EEG (PSG, Polysomnography), and other neurophysiological monitoring applications. This device is intended to be used only by physicians, technicians, or other medical professionals that are trained in either electroencephalography or polysomnography.

    Device Description

    The Natus Medical Incorporated (Natus) DBA Excel-Tech Ltd. (XLTEK) Comet-PLUS® (also known as the AS40-PLUS Amplifier System) is designed specifically for the EEG and PSG monitoring lab. The different configurations of the Comet-PLUS feature the AS40-PLUS Amplifier with electroencephalograph (EEG) or polysomnograph (PSG) Comet-PLUS Personality Modules (headboxes) and Natus software. The Comet-PLUS Amplifier is a compact AC Amplifier with up to 57 channels for EEG and PSG recording applications.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for the Comet-PLUS device. It details various performance tests and compliance with standards rather than specific acceptance criteria for a medical AI device and the results of a study demonstrating those criteria being met. The device described, Comet-PLUS, is an electroencephalograph (EEG) and polysomnograph (PSG) system, a hardware device for recording neurophysiological signals.

    Based on the content, the document does not contain the information requested in points 1-9 regarding acceptance criteria for an AI device and a study proving those criteria are met.

    Specifically:

    • No acceptance criteria or device performance for an AI algorithm: The document focuses on hardware (amplifier, headboxes) and firmware compliance with electrical safety, electromagnetic compatibility, and usability standards for an EEG/PSG system. There are no performance metrics like sensitivity, specificity, or AUC which are typical for AI-based diagnostic or assistive devices.
    • No mention of AI or machine learning: The document describes a medical device for signal acquisition and monitoring, not an AI algorithm.
    • No details on sample sizes, ground truth establishment, or expert reviews for an AI study: Since no AI study is described, this information is absent.
    • No MRMC comparative effectiveness study: The document does not describe any human-in-the-loop studies comparing human readers with and without AI assistance.
    • No standalone algorithm performance: The device is a system for recording signals, not a standalone algorithm.

    The "Summary of Performance Testing" section (page 5) details the types of tests conducted:

    • Software (firmware) validation: Compliance with FDA guidance documents and standards for medical device software.
    • Electrical Safety: Compliance with IEC 60601-1:2005, Am1:2012.
    • Electromagnetic Compatibility: Compliance with IEC 60601-1-2:2007.
    • Bench Performance Testing: Compliance with internal requirements and applicable clauses of IEC 60601-1-6, IEC 60601-2-26, IEC 62366, and ISO 80601-2-61.

    The conclusion states that these activities demonstrate the device's safety, effectiveness, and performance are as good as or better than predicate devices, leading to a substantial equivalence determination. However, this is for the hardware and its embedded firmware functionality, not an AI or machine learning algorithm.

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