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    K Number
    K222502
    Device Name
    KLICK (VARIANTS: POWER, RACE, MONSTER)
    Manufacturer
    KLAXON Mobility GmbH
    Date Cleared
    2022-12-16

    (120 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K192016
    Why did this record match?
    Device Name :

    KLICK (VARIANTS: POWER, RACE, MONSTER)

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

    KLICK is not intended for specific clinical use, but as a support to the mobility of active manual wheelchairs' users. It is designed to add auxiliary power to the manual wheelchair, increasing the mobility for the wheelchair's user. Therefore, bearing in mind the operating precautions described in this document, there is no need for professional, technical or aptitude requirements to operate or use a KLICK device.

    KLICK devices are intended as add-on devices for wheelchairs, thus the intended user is a person with motor disability who needs of the wheelchair support for movement.

    Device Description

    The KLICK 2021 device is a "TRACTION UNIT" (also called DRIVE UNIT or HUB) which is connected to the wheelchair (via a LINK SYSTEM) to provide electric propulsion to the three wheels resultant vehicle. The motor is in the front wheel (traction unit).

    The handlebar contains all the interfaces with which the user can drive the vehicle.

    The front castors rise off the ground and a single wheel, in the "traction unit", is used for steering.

    Klick can be used both with rigid or foldable wheelchairs.

    The main parts of the drive unit are as follows:

    • HUB (drive or traction unit): is the aluminium frame with brushless motor, steering set and aluminium fork, for both the steering and the traction functions
    • Motor: is a brushless unit with 250W nominal power for the Power variant and 1000W power for the Race and Monster variants
    • Wheel: aluminium rim, 14inch diameter for Power and Race, 20inch for Monster
    • Removable battery (available in 3 capacity versions: 11.6Ah, 5.8Ah, 2.9Ah)
    • Handlebar with user interfaces:
      • i. Throttle
      • ii. Cruise control, front/reverse selection switch
      • iii. Electronic brake
      • iv. Left hand mechanical brake
      • v. Right hand mechanical brake
      • vi. Display command for ON/OFF, level selection, on/off lights (optional), on/off usb charger
    • Display with driving informations, main parameters adjust.
    • Stand for support the device when disconnected from the vehicle
    • Battery charger is an external carriable unit (54,6V 2A) supplied by Klaxon-Mobility GmbH.

    The main parts of the connection system are:

    • Clamps: are always connected to the wheelchair, assembled by a Klaxon's trained specialist
    • Crossbeam: is connected to the clamps and supports the connector; the crossbeam is removable for installation on foldable wheelchairs. The connector is adjusted for each application by a Klaxon's trained specialist
    • Connector: it includes the front hook and connects the HUB to the crossbeam
    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request about acceptance criteria and a study proving device performance for an AI/ML powered medical device. The document is an FDA 510(k) premarket notification for a powered wheelchair attachment (Klick) and focuses on demonstrating substantial equivalence to a predicate device.

    Specifically, the document discusses:

    • The trade name, regulation, and classification of the Klick device.
    • Comparison of the Klick device with a predicate device (SMOOV O10) based on intended use, technology, and performance specifications.
    • Details about the Klick device's components (drive unit, motor, wheel, battery, handlebar controls, connection system).
    • A conclusion that the Klick device is as safe and effective as the predicate device despite some differences.

    It does not mention:

    • Acceptance criteria for an AI/ML powered medical device.
    • Any study proving an AI/ML powered device meets acceptance criteria.
    • Sample sizes for test or training sets related to AI/ML.
    • Data provenance for AI/ML studies.
    • Number or qualifications of experts for AI/ML ground truth.
    • Adjudication methods for AI/ML ground truth.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone performance for an AI/ML algorithm.
    • Types of ground truth used for AI/ML.
    • How ground truth for a training set was established for an AI/ML device.

    Therefore, I cannot extract the requested information from this document.

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