(299 days)
The ClearEdge® 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 including those certified and/or licensed in their state to prescribe and/or use balance devices such as certified athletic trainers, physical therapists, chiropractors, nurses and physicians. The ClearEdge® Balance System can be used wherever compatible Android mobile operating devices can be used.
The ClearEdge® Balance System is a mobile software system that analyzes balance through measurements of postural sway. The System is comprised of application software, and accompanying hardware consisting of a mobile computing device, proprietary sensor, balance pad, and friction pad. The test data is collected, uploaded to a HIPAA compliant server, analyzed by Motion Intelligence developed algorithms and presented in report form for clinician's review. The reports indicate how a subject's balance score may have changed between testing sessions, and whether the measured change is likely due to measurement error and normal human variation in performance of the selected balance stance or a real change in performance caused by an external factor.
Using proprietary software on an Android tablet and the Edge Sensor, the ClearEdge Balance System tests balance by administering eight select balance stances.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for the ClearEdge Balance System:
This document focuses on demonstrating substantial equivalence to a predicate device (Sway™ Balance System) rather than absolute performance against pre-defined, numerical acceptance criteria for a novel device. Therefore, the "acceptance criteria" presented are implicitly derived from the comparison to the predicate and statistical demonstrations of equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The core "acceptance criteria" for demonstrating substantial equivalence are based on demonstrating that the ClearEdge Balance System's performance is equivalent enough to the predicate device (Sway™ Balance System) to not raise new questions of safety or effectiveness. This is shown through a combination of laboratory testing and human performance testing.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (ClearEdge Balance System) |
|---|---|
| Laboratory Equivalence (Scoring) | Inverted Pendulum Testing: |
| (Regression Analysis) Scores highly correlated with predicate. | Linear Regression: r-values for all tests were greater than 0.97. Slopes of linear regression ranged between 0.92 and 1.05 (p |
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