(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 = <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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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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<121590
Materials
The Sway Balance™ System is a software only solution that utilizes the hardware of the Apple iOS mobile operating system for products such as the iPhone 3G, 3GS, 4, 4S, iPad, iPad2 and iPod Touch. The built in accelerometer is accessed to analyze motion during a balance test.
Testing
Device testing was conducted to evaluate conformance to product specification. The results showed the system met specification. Product verification consisted of studies comparing the Sway Balance™ System to force platform technology. 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 = <0.05). Mean Actual Stability Scores on the balance platform was 1.41±0.90 compared to 1.38±0.72 using the mobile device.
Studies also analyzed performance of balance tasks of varying difficulty to measure the device's effectiveness in determining levels of stability. Data showed that the Sway Balance™ System results were consistent with expected outcomes. Within subject reliability was evaluated under conditions of instantaneous acceleration forces.
Summary of Substantial Equivalence
The Sway Balance™ System is equivalent to the predicate product. The intended use, targeted population and basic premise underlying the balance assessment are equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 20 2012
Capacity Sports, LLC c/o Pamela M. Buckman, MSN Buckman Company, Inc. 2800 Pleasant Hill Rd., Suite 175 Pleasant Hill, CA 94523
Re: K121590
Trade/Device Name: Sway Balance™ Regulation Name: Vestibular Analysis Apparatus Regulatory Class: Unclassified Product Code: LXV Dated: August 8, 2012 Received: August 10, 2012
Dear Ms. Buckman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The read haly annous provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adviteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be finay of subject to additions, Title 21, Parts 800 to 898. In addition, FDA may . publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of devices that I Drimination that your device complies with other requirements of the Act that I Dri has intact and regulations administered by other Federal agencies. You must or any I odetar states and the equirements, including, but not limited to: registration and listing (21 Comply will an the Fee Broques and 801); medical device reporting (reporting of medical
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Page 2 - Pamela M. Buckman. MSN
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Malvina B. Evdelman, M.D. Director
Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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K12159D
Intended/Indications for Use
510(k) Number:
Device Name:
Sway Balance™ System
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.
Prescription Use
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Per 21 CFR 801 Subpart D)
X
(21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation
signature
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number
N/A