(112 days)
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.
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.
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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