Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K022993
    Manufacturer
    Date Cleared
    2002-12-02

    (84 days)

    Product Code
    Regulation Number
    890.3860
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Hoveround Rehab Seating System is intended for people using a powered wheelchair and requiring positional change.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information regarding acceptance criteria or a study that proves a device meets such criteria.

    The document is a US FDA 510(k) clearance letter for the "Hoveround Rehab Seating System." This letter:

    • Confirms that the device is substantially equivalent to a legally marketed predicate device.
    • States the regulatory class and product code.
    • Outlines general control provisions the manufacturer must adhere to (registration, listing, GMP, labeling, etc.).
    • Provides contact information for regulatory compliance.
    • Includes the Indications For Use.

    It does not contain details about:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes for test sets or data provenance.
    • Number/qualifications of experts for ground truth.
    • Adjudication methods.
    • MRMC comparative effectiveness studies.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • Sample size for training sets.
    • How ground truth for training sets was established.

    Therefore, I cannot fulfill your request as the necessary information is not present in the provided input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1