(112 days)
No
The document describes a system that analyzes accelerometer data to assess balance. There is no mention of AI, ML, or any related techniques in the description, performance studies, or key metrics. The analysis appears to be based on direct measurement and comparison to a predicate device.
No.
The device is intended for assessment and analysis of sway as an indicator of balance, not for treatment or therapy.
Yes
The device assesses sway as an indicator of balance, and mentions that "Conditions affecting postural sway include nausea, headache, orthopedic injury, ear infection, medications, head injury, dehydration and fatigue," suggesting it aids in the diagnosis of these underlying health conditions.
Yes
The device description explicitly states that the Sway Balance™ System is a "stand-alone mobile operating system software application that does not include any peripheral hardware add-ons." While it utilizes the built-in accelerometer of a mobile device, the device itself is the software application.
Based on the provided information, the Sway™ Balance System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The Sway™ Balance System analyzes balance through thoracic sway using a mobile device's accelerometer. It does not involve the analysis of blood, urine, tissue, or any other biological specimen.
- The intended use is to assess balance as an indicator of sway. This is a functional assessment of a physical characteristic, not a diagnostic test performed on a biological sample.
- The device description focuses on software and accelerometer data. There is no mention of reagents, assays, or any components typically associated with IVD devices.
Therefore, the Sway™ Balance System falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
LXV
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Bench testing analyzed the sensitivity of the software program to access data from the ST Microelectronics MEMS Accelerometer built into the smartphone compatible with the Sway Balance™ Software. Sensitivity scores using the Sway Balance™ Software were comparable.
Clinical testing included studies comparing the Sway Balance™ System to force platform assessment tools to establish positive correlations between the two devices. Results showed no significant difference between the two data sets (p =
N/A
0
SEP
20
2012
510(k) Summary
K Number
General Information
Classification
Trade Name
Sway Balance™
Unclassified
Submitter
Capacity Sports, LLC 624 S. Boston Ave., Suite 700 Tulsa, OK 74119 Tel: (918) 728-1688 Fax: (918) 712 1833
Contact
Pamela M. Buckman, MSN Buckman Company, Inc. 2800 Pleasant Hill Rd., Suite 175 Pleasant Hill, CA 94523 Tel: 925 980 7007 Fax: 925 705 7381
Indications for 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.
Predicate Device(s)
Korebalance™ by SPORTKAT, LLC (K070676)
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.
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