LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K042401
    Device Name
    VARI-ABLE APB (ADAPTABLE POSITIONING BASE)
    Manufacturer
    AMERICAN TRACK ROADSTERS, INC.
    Date Cleared
    2004-10-07

    (34 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K921136
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K921136

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

    The intended use of the Vari-Able, APB (Adaptable Positioning Base) mechanical wheelchair is to provide mobility to persons with a primary pediatric indication who are limited to a sitting position.

    Device Description

    The Vari-Able, APB (Adaptable Positioning Base) is a manually operated, attendant controlled, manual, mechanical wheelchair and patient positioning system. It is designed to provide mobility and optimized positioning for patients who require long term accommodation due to conditions of severe physical motion restriction. Patients with diagnosis such as cerebal palsy, would typically benefit from the use of the Vari-Able, APB (Adaptable Positioning Base).

    The product consists of a steel/aluminum frame, rear wheels (which can be substituted based on patient requirements), a seat pail, from with adjustments for seating configuration, and manual brakes, anti-tip wheels, footrests, and other components such as head and trunk support, and other components as needed. The APB will accommodate the positioning and seating systems currently available in the market.

    The product is capable of many configurations of the frame, wheels, and components to accommodate patients with difficult to solve positioning requirements. Using the manual adjustments that can be made to the frame, the angle of the chair may be changed to accommodate the patient's needs.

    The Vari-Able APB (Adaptable Positioning Base) also features weight shifting capabilities using manual tilt-in-space and recline features. This also can assist in positioning and feeding.

    The product is designed to function indoors or outdoors on surfaces such as sidewalks and other public places.

    AI/ML Overview

    The provided text describes a 510(k) summary for the Degage's Vari-Able APB Manual Wheelchair. Based on the content, here's a breakdown of the requested information, focusing on what is present and explicitly stating what is not available in this document:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Substantial Equivalence with Predicate Device (Labac MTC (K921136)) in materials, construction, configuration, indications, and use.The Vari-Able APB and the Labac MTC were tested using a methodology based on ANS/RESNA WC-1:1998, Volume 1-1776 - Requirements and Test Methods for Wheelchairs (Including Wheelchair Seating). Tests for backward, forward, sideways, posterior, and anterior stability indicate the two devices are substantially equivalent.

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

    The document states that the "Vari-Able APB and the Labac MTC were tested," but it does not specify the sample size for the test set (e.g., number of wheelchairs, number of subjects).
    The data provenance is not explicitly stated (e.g., country of origin of the data, retrospective or prospective). It can be inferred that the testing was likely conducted in the US by the submitter, given the FDA submission, but this is not definitively stated.

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

    There is no mention of experts being used to establish ground truth for this type of device (a mechanical wheelchair). The performance data refers to stability tests based on a recognized standard (ANS/RESNA WC-1:1998). "Ground truth" in this context would likely be objective measurements of physical properties against the standard, not expert consensus.

    4. Adjudication Method for the Test Set

    This is not applicable as there is no mention of expert consensus or subjective assessments that would require an adjudication method. Performance was assessed via objective stability tests.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

    No MRMC comparative effectiveness study was done or mentioned. This type of study is typically for diagnostic imaging or similar devices where reader interpretation is a key component.

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

    This is not applicable as the device is a mechanical wheelchair, not an algorithm or AI system. Its performance is inherent in its physical design and construction.

    7. The Type of Ground Truth Used

    For the performance data, the "ground truth" seems to be the objective measurements of stability as defined by the ANS/RESNA WC-1:1998 standard. There is no mention of pathology, expert consensus, or outcomes data used as ground truth for verifying the device's performance in this context.

    8. The Sample Size for the Training Set

    This is not applicable as the device is a mechanical wheelchair and does not involve a "training set" in the context of an AI or machine learning model.

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

    This is not applicable for the same reasons as #8.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1