(148 days)
EQ Balance is intended to assess body tilt as an indicator of balance. Individual suitability for assessment must be judged on a case by case basis, by a qualified 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. Interpretation of EQ Balance results should only be made by a healthcare professional, as part of a multifaceted assessment of balance. Conditions affecting postural sway include nausea, headache, orthopedic injury, ear infection, medications, head injury, dehydration and fatigue. EO Balance should be used in an indoor setting free from obstructions and free from excessive noise or visual distractions. EQ Balance should be only be used as directed by your healthcare practitioner. EQ Balance may be used on mobile devices running iOS or Android operating systems.
EQ Balance is a mobile balance test to be used on mobile phone and tablet devices with iOS version 10.3 or later, or Android OS version 6 or later. EQ Balance measures balance using the accelerometer within the device.
EQ Balance utilizes an algorithm that calculates a balance score based on the analysis of subject movements detected by the device's internal accelerometer. Balance is measured during a series of stances with the mobile device held to the chest by the user. Users follow the step-by-step voice guidance that runs after launching the app during the entirety of the test to ensure consistency in obtaining balance measures. EQ Balance does not function as a diagnostic test, and EQ Balance results should be interpreted by qualified individuals only.
The provided text details the 510(k) summary for the EQ Balance device, which is intended to assess body tilt as an indicator of balance. The study's primary goal was to demonstrate substantial equivalence to the predicate device, Sway Balance.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the performance testing verified that "EQ Balance and the Sway™ Balance System (Sway) are in statistical agreement." The agreement was primarily assessed using Spearman's analysis and Deming Regression Model.
| Acceptance Criteria / Performance Metric | Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Statistical Agreement (3-pose average) with Predicate (Sway Balance) | Not explicitly stated, implied to be demonstrable statistical agreement | Spearman's analysis: "the 3-pose average measures calculated by EQ Balance were in statistical agreement with the 3-pose average obtained with Sway Balance for both normal and balance-impaired groups, and for all three stances (double leg, tandem right and left)." | |
| Deming Regression Model: "showed agreement between the 3-pose average balance measures (the primary device output), as well as 23 of the 27 additional analyses that were conducted." | The study aimed to show agreement rather than a specific statistical threshold for acceptance. | ||
| Intraclass Correlation (ICC) for consistency of EQ Balance measure | Not explicitly stated. Implied to be strong consistency. | ICC for the cohort was 0.75 (p |
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