Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K202728
    Date Cleared
    2022-02-10

    (510 days)

    Product Code
    Regulation Number
    890.3900
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Action Trackchair Hawk

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

    The Action Trackchair all-terrain power wheelchair provides mobility to individuals who need a power wheelchair and are capable of operating a powered wheelchair.

    Device Description

    Action Trackchair Hawk

    AI/ML Overview

    My apologies, but the provided text is a 510(k) clearance letter from the FDA for a medical device called "Action Trackchair Hawk." This document primarily addresses regulatory aspects, such as substantial equivalence to predicate devices, and outlines general controls and regulations.

    It does not contain any information regarding:

    • Acceptance criteria for device performance.
    • Details of a study proving the device meets acceptance criteria.
    • Sample sizes for test or training sets.
    • Data provenance.
    • Number or qualifications of experts for ground truth.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone algorithm performance.
    • Type of ground truth used (e.g., pathology, outcomes data).
    • How ground truth for the training set was established.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This information would typically be found in a separate study report, clinical trial summary, or a more detailed device description submitted as part of the 510(k) application, which is not included here.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1