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510(k) Data Aggregation

    K Number
    K021605
    Device Name
    MEDGEM
    Manufacturer
    HEALTHETECH, INC.
    Date Cleared
    2002-06-14

    (29 days)

    Product Code
    BZL
    Regulation Number
    868.1730
    Type
    Special
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDGEM

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

    The MedGem is intended for use in clinical and research applications to measure oxygen uptake.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the MedGem device, stating its intended use and regulatory classification. It does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a test set.
    3. Information on experts used to establish ground truth.
    4. Adjudication methods.
    5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes related to AI assistance.
    6. Results of a standalone algorithm performance study.
    7. The type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    The document primarily focuses on the regulatory clearance of the device based on substantial equivalence to a predicate device, rather than a detailed performance study report.

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