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510(k) Data Aggregation

    K Number
    K121590
    Device Name
    VESTIBULAR ANALYSIS APPARATUS
    Manufacturer
    CAPACITY SPORTS, LLC
    Date Cleared
    2012-09-20

    (112 days)

    Product Code
    LXV
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K070676
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAPACITY SPORTS, LLC

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

    The Sway™ Balance System is intended for use to assess sway as an indicator of balance. Individual suitability for assessment must be judged on a case by case basis, by a qualified individual including those certified and/or licensed in their state to prescribe and/or use balance devices such as certified athletic trainers and coaches, physical therapists, nurses and physicians. Conditions affecting postural sway include nausea, headache, orthopedic injury, ear infection, medications, head injury, dehydration and fatigue. The Sway™ Balance System can be used wherever an iOS mobile operating device is available.

    Device Description

    The Sway Balance™ System is a mobile measurement system that analyzes balance through thoracic sway, using the built in accelerometer of a mobile device. The Sway Balance™ System is a stand-alone mobile operating system software application that does not include any peripheral hardware add-ons.

    AI/ML Overview

    The provided text is a 510(k) summary for the Sway Balance™ System, a mobile application designed to assess balance. Based on this document, here's an analysis of the acceptance criteria and the study proving the device meets them:

    1. Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implied)Reported Device Performance
    Functional Equivalence/Accuracy: The device should accurately measure sway as an indicator of balance, comparable to established methods.Bench Testing: Analyzed the sensitivity of the software program to access data from the built-in accelerometer. "Sensitivity scores using the Sway Balance™ Software were comparable" to those of a force platform.
    Clinical Testing (Correlation): Compared the Sway Balance™ System to force platform assessment tools. "Results showed no significant difference between the two data sets (p =
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