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510(k) Data Aggregation

    K Number
    K072311
    Device Name
    TILITE AERO X
    Manufacturer
    TISPORT, LLC
    Date Cleared
    2007-09-21

    (35 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Abbreviated
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K890050
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The intended use for the TiLite Aero X is to provide mobility to physically impaired individuals.

    Device Description

    The TiLite Aero X is a folding manual wheelchair. The frame components of the TiLite Aero X are tubular aluminum alloy. The folding mechanism components of the TiLite Aero X are extruded aluminum alloy.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device, the TiLite Aero X folding manual wheelchair. It does not contain information about acceptance criteria or a study proving its performance in the context of AI/ML or diagnostic accuracy. Instead, it focuses on the device's classification, predicate device, and compliance with existing standards for manual wheelchairs.

    Therefore, I cannot fulfill your request for the specific points related to acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment in the context of an AI/ML device.

    The only relevant information regarding "testing results" is:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Standard)Reported Device Performance (Compliance)
    ANSI/RESNA WC/Volume 1: 1998, Section 1Meets requirements
    ANSI/RESNA WC/Volume 1: 1998, Section 5Meets requirements
    ANSI/RESNA WC/Volume 1: 1998, Section 7Meets requirements
    ANSI/RESNA WC/Volume 1: 1998, Section 8Meets requirements
    ANSI/RESNA WC/Volume 1: 1998, Section 16Meets requirements
    ANSI/RESNA WC/Volume 1: 1998, Section 93Meets requirements

    The following information cannot be extracted from the provided text as it pertains to AI/ML device evaluation, which is not applicable to this document:

    1. Sample size used for the test set and the data provenance
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
    3. Adjudication method for the test set
    4. If a multi reader multi case (MRMC) comparative effectiveness study was done and its effect size.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
    7. The sample size for the training set.
    8. How the ground truth for the training set was established.
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