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510(k) Data Aggregation

    K Number
    K022506
    Device Name
    MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM
    Manufacturer
    WIDEMED LTD
    Date Cleared
    2003-05-15

    (289 days)

    Product Code
    MNR
    Regulation Number
    868.2375
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K955841
    Predicate For
    K070326,K083620,K112102
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Morpheus ™ 1 Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders.

    The Morpheus ™ 1, Automated Sleep Study Scoring and Data Management System is intended to be used for analysis (automatic scoring and manual re-scoring), display, redisplay (retrieve), summarize, reports generation and networking of data received from monitoring devices typically used to evaluate sleep and respiratory related sleep disorders.

    This device is to be used under the supervision of a physician.

    Device Description

    The Morpheus™ 1, Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of sleep and respiratory disorders.

    The Morpheus 100 1, Automated Sleep Study Scoring and Data Management System is intended to be used for analysis (automatic scoring and manual rescoring), display, redisplay (retrieve), summarize, reports generation and networking of data received from monitoring devices typically used to evaluate sleep and respiratory related sleep disorders.

    AI/ML Overview

    This document primarily focuses on the FDA 510(k) clearance for the Morpheus™ 1 Automated Sleep Study Scoring and Data Management System, establishing its substantial equivalence to a predicate device. It does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.

    Therefore, I cannot provide the requested table and study description based on the provided text. The document is an FDA letter and a declaration of indications for use, not a clinical study report.

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