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    K Number
    K050507
    Device Name
    SMARTECH, MODEL HOLI I
    Manufacturer
    CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER
    Date Cleared
    2005-07-07

    (129 days)

    Product Code
    INI,89I
    Regulation Number
    890.3800
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K033239
    Why did this record match?
    Device Name :

    SMARTECH, MODEL HOLI I

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

    The HOLI I scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

    Device Description

    The HOLI I scooter is motor driven, indoor and outdoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position. The HOLI I scooter is with a 130 kg (286 lbs) weight capacity. The scooter is basic conventional rear wheel drive, rigid frame vehicle that are battery powered. It consists primarily of a welded steel frame, lighting system, a sealed transaxle motor drive system, electromagnetic braking system, electric motor controller, two batteries with an off-board charger and an adjustable seat. It also includes a tiller handle for steering and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions. The scooter is powered by two 12 volt lead-acid DC batteries with 27 km (16.9 miles) with 32/36AH which maximum speed upto 9.5 km/hr (5.6 mph).

    AI/ML Overview

    The provided text describes the "HOLI I scooter" and its equivalence to a predicate device, focusing on non-clinical testing. It does not contain information about the acceptance criteria or a study proving device performance using human reader data, as generally understood in the context of AI/software medical devices.

    Here's an analysis based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document outlines an equivalency claim based on compliance with established performance standards for wheelchairs, not "acceptance criteria" in the sense of a study's primary endpoints for a medical device's diagnostic output. The "reported device performance" is essentially that the device meets these standards.

    Acceptance Criteria (Standard)Reported Device Performance
    ANSI/RESNA WC/Vol.1 section 1-1998 / ISO7176-1-1999 (Static Stability)Device meets this standard.
    ANSI/RESNA WC/Vo1.1 section 8-1998 / ISO7176-8-1998 (Static, Impact, and Fatigue Strengths)Device meets this standard.
    ANSI/RESNA WC/Vo1.2 section 21-1998 / ISO7176-21-2003 (Electromagnetic Compatibility)Device meets this standard.
    CISPR 11-1990 (Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment)Device meets this standard.
    IEC 61000-4-2-1995 (EMC-Electrostatic Discharge Immunity Test (ESD))Device meets this standard.
    IEC 61000-4-3-1995 (EMC-RF Electromagnetic Field Immunity Test)Device meets this standard.
    California Bureau of Home Furnishings 116 (Flammability Standards)Device meets this standard.

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

    This information is not provided in the document. The testing described is for physical product standards (e.g., stability, strength, EMC) and would typically involve a small sample of the physical device rather than a "test set" of data as in software/AI. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).

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

    This information is not applicable and therefore not provided. The "ground truth" for compliance with these engineering standards is the outcome of the physical test itself (e.g., the device did not tip over, it withstood the impact, etc.), not expert interpretation of data.

    4. Adjudication Method for the Test Set:

    This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are used for expert consensus on medical image interpretations or clinical outcomes, which is not the type of testing described here.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

    No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical scooter, not an AI or software device that assists human readers.

    6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

    No, a standalone study in the context of an algorithm's performance was not done. The "studies" were non-clinical tests of the physical scooter's performance against engineering standards.

    7. Type of Ground Truth Used:

    The "ground truth" implicitly used is the objective outcome of the engineering and safety tests defined by the various ANSI/RESNA, ISO, IEC, CISPR, and California Bureau of Home Furnishings standards. This is not medical expert consensus, pathology, or outcomes data.

    8. Sample Size for the Training Set:

    This information is not applicable and therefore not provided. The development of a physical product like a scooter does not involve a "training set" in the context of AI/machine learning.

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

    This information is not applicable and therefore not provided. There is no training set for this type of device. The design and manufacturing would be based on engineering principles and compliance with the relevant standards.

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