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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
    Predicate For
    K173669,K183661,K190735
    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 = <0.05)." The mean actual stability scores were very close: Force platform: 1.41±0.90; Mobile device: 1.38±0.72. Clinical Testing (Sensitivity to Balance Levels): Evaluated the device's effectiveness in determining levels of stability across tasks of varying difficulty. "Data showed that the Sway Balance™ System results were consistent with expected outcomes."
    Reliability/Consistency: The device should provide consistent measurements."Within subject reliability was evaluated under conditions of instantaneous acceleration forces." While the document states it was "evaluated," it does not provide specific results or metrics for this evaluation. However, the lack of significant difference in the correlation study implies good reliability for general use.
    Safety and General Performance: The device should not introduce new risks and should perform as intended without significant issues."Device testing was conducted to evaluate conformance to product specification. The results showed the system met specification." The FDA's substantial equivalence determination also implies that the device meets general safety and performance requirements for devices of its type, given its equivalence to the predicate device.
    Substantial Equivalence: The device should be substantially equivalent to a legally marketed predicate device."The Sway Balance™ System is equivalent to the predicate product. The intended use, targeted population and basic premise underlying the balance assessment are equivalent." This is the ultimate acceptance criterion for 510(k) clearance, and it was met.

    2. Sample Size and Data Provenance (Test Set)

    • Sample Size: The document does not explicitly state the sample size for the clinical testing (which serves as the "test set" for performance evaluation). It mentions "studies" (plural) but no numbers of participants.
    • Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.

    3. Number of Experts and Qualifications (Ground Truth for Test Set)

    • This information is not provided in the document. The ground truth (force platform data) is established by a device, not human experts in this context.

    4. Adjudication Method (Test Set)

    • This is not applicable for this type of device comparison study. The ground truth is established by a quantitative measurement (force platform), not through expert consensus requiring adjudication.

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

    • No, an MRMC study was not done. This device is a quantitative measurement tool, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. The study focuses on comparing the device's output to a gold standard measurement device, not on how it assists human interpretation.

    6. Standalone (Algorithm Only) Performance

    • Yes, standalone performance was assessed. The entire testing described (bench testing and clinical testing comparing to a force platform) is an assessment of the algorithm's standalone performance, i.e., how accurately the Sway Balance™ System itself measures sway. There is no human element in the loop of this specific performance evaluation.

    7. Type of Ground Truth Used

    • The ground truth used was comparative device data, specifically data obtained from "force platform technology." Force platforms are established gold standards for measuring balance and sway.

    8. Sample Size for the Training Set

    • The document does not mention a training set or its size. As a software application utilizing a built-in accelerometer to measure physical motion, it's possible that a traditional "training set" for machine learning algorithms (as understood in the context of image recognition or complex pattern detection) was not explicitly used or documented in this summary. The development likely involved calibration and verification against physical principles and established balance measurement techniques rather than training on a large dataset of patient balance assessments.

    9. How Ground Truth for the Training Set Was Established

    • Since a distinct "training set" is not mentioned, the method for establishing its ground truth is not provided. If implied, the "training" (or development and calibration) would be based on the known physics of accelerometry and validation against physical movements and potentially against force platform data during the development phase.
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