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510(k) Data Aggregation

    K Number
    K032101

    Validate with FDA (Live)

    Device Name
    POWERSTAND STAND-UP WHEELCHAIR
    Manufacturer
    THE STANDING CO., INC.
    Date Cleared
    2004-01-22

    (198 days)

    Product Code
    IPL
    Regulation Number
    890.3900
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Powerstand Standing Wheelchair in indicated, BY PRESCRIPTION ONLY, for users who have had, or may have in the future, positioning disorders relating to paralysis, paresis or general weakness. The Powerstand Standing Wheelchair helps users with mobility.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Powerstand Stand-up Wheelchair." It is a regulatory document and does not contain any information about acceptance criteria, device performance studies, or AI/algorithm-related details.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size and data provenance for a test set.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method for the test set.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study details.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    This document is solely focused on the FDA's determination of substantial equivalence for a physical medical device.

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