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510(k) Data Aggregation

    K Number
    K033032
    Device Name
    WU'S 3-WHEELED NEO SCOOTER, MODEL WT-M3JR
    Manufacturer
    WU'S TECH CO., LTD.
    Date Cleared
    2003-11-10

    (45 days)

    Product Code
    INI
    Regulation Number
    890.3800
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K014119
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

    Device Description

    The WU'S 3-WHEELED SCOOTER WT-M3Jr is an indoor / outdoor electric scooter that is battery operated. It has a base with four-wheeled with a seat, armrests, and a front basket. The movement of the scooter is controlled by the rider who uses hand controls located at the top of the steering column. The device can be disassembled for transport and is provided with an onboard battery charger.

    AI/ML Overview

    The medical device in question is the "WU'S 3-Wheeled Scooter, WT-M3Jr", an electrical scooter intended for medical purposes to provide mobility to persons restricted to a seated position.

    This is a 510(k) premarket notification, which means the device is seeking substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with established acceptance criteria. Therefore, the information provided focuses on the comparison to the predicate device and performance testing relevant to safety standards, rather than clinical performance metrics typical of AI/diagnostic devices.

    Here's an analysis based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    For this device type (electrical scooter), acceptance criteria are primarily related to safety and build quality, demonstrated through compliance with recognized standards and comparison to a predicate device. There aren't specific "performance metrics" in the clinical sense like sensitivity or specificity.

    Acceptance Criteria (Demonstrated via)Reported Device Performance
    Safety and Electrical System Equivalence"The electronic systems between two devices are the same and all passed by the UL certificated, for instance the electronic controller, batteries and recharge. Thus the same safety level for the two devices is assured."
    Electromagnetic Compatibility (EMC)"EMC Report ANSI / RESNA WC/Vol.2-1998, CISPR 11: 1990, EN61000-3-2: 1995, IEC61000-3-3: 1995 (Electrically powered wheelchairs, scooters, and their chargers - requirements and test methods)" - Implies adherence to these standards for safety in electromagnetic environments.
    Functional Equivalence (with improvements)The new device (WT-M3Jr) is noted to be "more agile and easy to storage or transportation" compared to the predicate (WT-M3, K014119), which is for "general use". Differences in overall dimension, tire size, and weight are acknowledged but deemed not to affect safety. The overall appearance is also deemed not a safety aspect.
    Substantial Equivalence to Predicate Device (WU'S 3-WHEELED NEO SCOOTER WT-M3 (K014119))The FDA determined the device is "substantially equivalent" to legally marketed predicate devices for the stated indications for use.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: Not applicable in the context of clinical test sets for diagnostic accuracy. The "testing" here refers to engineering and safety compliance, likely involving one or a few units of the scooter for standard testing.
    • Data Provenance: The document does not specify the country of origin for the performance testing data beyond the manufacturer being in China (Taiwan). The testing is prospective for the specific device being submitted, following established engineering standards.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

    • Not applicable as this is an electrical scooter, not an AI/diagnostic device requiring expert consensus for a clinical ground truth. The "ground truth" here is compliance with engineering standards as assessed by testing laboratories and regulatory bodies.

    4. Adjudication Method for the Test Set

    • Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical evaluations, typically for AI or diagnostic devices.

    5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

    • No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI assistance on human reader performance in diagnostic tasks, which is not applicable to an electrical scooter.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    • Not applicable. This device is an electrical scooter and does not feature an algorithm or AI component that would be evaluated for standalone performance.

    7. The Type of Ground Truth Used

    • The "ground truth" for this device's acceptance is primarily compliance with recognized safety and performance standards (e.g., EMC standards, UL certification) and demonstrated substantial equivalence to a legally marketed predicate device. This is based on technical specifications and engineering tests, not clinical outcomes or pathology.

    8. The Sample Size for the Training Set

    • Not applicable. This device does not use machine learning or AI and therefore does not have a "training set" in that context.

    9. How the Ground Truth for the Training Set Was Established

    • Not applicable, as there is no training set for this device.
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