(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 < 0.00). |
| (Deming Regression) 95% CI for slope contains 1, 95% CI for intercept contains 0. | Deming Regression: The 95% confidence interval for the slope contained the value 1. The 95% confidence interval for the intercept contained the value 0. |
| Human Performance Equivalence | Two One-Sided Test Procedure (TOST): |
| (Mean Difference) Mean difference between ClearEdge and Sway scores falls within a pre-defined equivalence margin. | The equivalence margin was set to ±10 (based on an effect size of 0.4 relative to the standard deviation of difference scores). The upper end of the 90% confidence interval for the difference between means of ClearEdge scores was less than the upper end of the equivalence margin (r < 0.00). The lower end of the 90% confidence interval for the difference between means of ClearEdge scores was greater than the lower end of the equivalence margin. The confidence interval was contained within the equivalence margin, demonstrating equivalence. The p-values for the human performance TOST were 0.0008 for the lower equivalence margin and 0.00007 for the upper equivalence margin, satisfying the condition for substantial equivalence at a significance level of 0.05. |
| Minimal Detectable Change (MDC) Calculation | MDC established for each of 8 stances: The MDC was calculated for the 95% confidence level for each balance stance. The difference scores (test-retest) were found to be normally distributed. The MDC is proportional to the Standard Error of Measurement (SEM), calculated as 1.96 x √2 x SEM. Specific numeric values for SEM and MDC vary per stance but represent the threshold for separating real change from measurement error at the 95% confidence level. |
The Study Proving the Device Meets Acceptance Criteria
The study described is a comparative study designed to establish substantial equivalence to a predicate device (Sway™ Balance System), rather than a de novo validation against absolute performance metrics.
-
Sample Size Used for the Test Set and Data Provenance:
- Laboratory Testing: Involved continuous movement data from an "inverted pendulum." The specific sample size in terms of number of data points or test runs is not explicitly stated, but the "Figure 0" implies a variety of frequency and amplitude combinations were tested on the pendulum. The "dots represent the actual frequency & Amp for Sway & CE Score." This is a controlled laboratory environment; data provenance is lab-generated.
- Human Performance Testing: 34 subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin, single vs. multi-site), but implies a prospective human study.
- Retrospective/Prospective: The description "Supplemental clinical testing compared ClearEdge Balance and Sway Balance scores for 34 subjects..." suggests a prospective data collection for this direct comparison.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Laboratory Testing: The ground truth for the inverted pendulum test is the mechanical input (frequency and amplitude). No human expert is involved in establishing this ground truth.
- Human Performance Testing: The "ground truth" in this comparative study is the Sway™ Balance System's score. The study aims to show that ClearEdge's scores are equivalent to Sway's. There are no independent human experts establishing a "true" balance score against which both devices are compared. The assumption is that Sway's measurement is a valid indicator of balance.
- MDC Development: This involved a test-retest repeatability study with 144 subjects (109 healthy, 35 with neurologic condition). The "ground truth" is derived from statistical analysis of repeated measurements from the ClearEdge system itself, not from expert adjudication of balance.
-
Adjudication Method for the Test Set:
- Not applicable in the traditional sense for these studies.
- For the laboratory testing, the "truth" is the known physical properties and movements of the inverted pendulum.
- For the human performance testing, the comparison is directly between the two devices (ClearEdge and Predicate Sway). There's no third-party adjudication of the "true" balance of the subjects. The statistical method used was a Two One-Sided Test Procedure (TOST) to demonstrate equivalence.
-
If A Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- No, an MRMC study was NOT done. This device is a balance assessment system, not an AI-assisted diagnostic imaging device that involves human "readers" or interpretation of complex images. The focus is on the device's ability to measure balance similarly to a predicate device.
-
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, implicitly. Both the laboratory testing with the inverted pendulum and the human performance testing effectively evaluate the algorithm's performance in producing a score based on sensor input. The device's output (a numeric balance score) is the direct result of its algorithms. There isn't a human "in the loop" modifying the score; the human users apply the device and interpret its output, but the calculation of the score itself is standalone.
-
The Type of Ground Truth Used:
- Laboratory Testing: Mechanical parameters of an inverted pendulum as a model for human sway.
- Human Performance Testing: The scores generated by the legally marketed predicate device (Sway™ Balance System) are used as the reference "truth" for comparison, demonstrating equivalence.
- MDC Development: Statistical derivation from repeated measurements of the device under test (ClearEdge) itself on human subjects to determine variability.
-
The Sample Size for the Training Set:
- Not explicitly stated for a distinct "training set." This submission details validation studies for a device rather than a deep learning AI model that would typically have a separate, large training set. The device appears to rely on established biomechanical models and signal processing rather than machine learning that requires supervised training.
- The term "developed algorithms" for Motion Intelligence suggests proprietary methods, but details on how these were "trained" (if they involve machine learning) are absent. The MDC development study (144 subjects) could be considered a form of internal validation used to characterize the device's measurement properties.
-
How the Ground Truth for the Training Set Was Established:
- As a distinct "training set" is not explicitly mentioned for algorithm development in line with deep learning, the method for establishing its "ground truth" is also not detailed.
- For the MDC development, the "truth" for calculating measurement error and normal variation is derived from repeat measurements of the same individuals, assuming that changes between short-interval tests beyond a certain threshold represent actual change rather than random variability.
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October 22, 2019
Quadrant Biosciences Bryan Greene Vice President - Operations 505 Irving Avenue Syracuse, New York 13210
Re: K183661
Trade/Device Name: ClearEdge Balance System Regulation Number: 21 CFR Regulation Name: N/A Regulatory Class: Class II Product Code: LXV Dated: September 20, 2019 Received: September 23, 2019
Dear Bryan Greene:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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 found in the Code of Federal Regulations, 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Vasant Dasika Acting Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183661
Device Name ClearEdge® Balance System
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
-
- Date Summary Prepared: 21 October 2019
-
- Submitter: Quadrant Biosciences dba Motion Intelligence, Inc. 505 Irving Avenue, Suite 3100AB Syracuse, NY 13210 Contact: Bryan Greene Ph: 315-614-2325 ext 1001
- ClearEdge Balance System 3. Trade Name:
-
- Common Name: Recorder, Attention Task Performance
- న్. Device Description: 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.
6. Indication for Use:
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, chiropractors, nurses and physicians. The ClearEdge® Balance System can be used wherever compatible Android mobile operating devices can be used.
| 7. | Classification: | Regulation: | Unclassified |
|---|---|---|---|
| Class II | 510(k) | ||
| Product Code: | LXV | ||
| Classification | Unclassified | ||
| Panel: | Ear Nose & Throat | ||
| 8. | Predicate Device(s): | 510(k) Number: | K121590 |
| Manufacturer: | Capacity Sports, LLC | ||
| Trade Name: | Sway™ Balance System | ||
| Product Code: | LXV | ||
| Classification: | Unclassified |
9. Compliance to Special Controls / Performance Standards: Compliance to the following recognized consensus standards is declared:
Technical / Product-Related Standards:
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- IEC 60601-1:2012 Ed 3.1 General requirements for basic safety and essential performance, FDA#19-5 ●
- IEC 60601-1-2:2014 Ed 4 Medical electrical equipment Part 1-2: General requirements for basic safety ● and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, FDA #19-8
- . IEC 60601-1-6 Issued: 2013/10/29 Ed: 3.1 Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability, FDA #5-89
- . IEC 60601-1-11 Issued: 2015/01/20 Ed. 2 Medical Elec. Equip.- Part 1-11: Gen. Req. for Basic Safety & Essential Performance - Collateral Standard - Req. for Medical Elec. Equip. & Medical Elec. Systems Used in the Home Healthcare Environment, FDA #19-14
- IEC 60529:2013 Degrees Of Protection Provided By Enclosures (IP Code), FDA #None
- . 47CFR Part 15 Federal Communications Commission (FCC), FDA #None
- . ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirement, FDA #5-90
Quality System, Risk Management & Process-Related Standards:
- 21CFR820: Part 820 Quality System Regulations, FDA #None ●
- IEC 62366 Issued: 2014/01/28 Ed. 1.1 Medical Devices Application of Usability Engineering to . Medical Devices, FDA #5-87
- . IEC 62304:2006 Medical device software - Software life cycle processes, FDA #13-8
- ISO 14971:2012 Medical devices Application of risk management to medical devices, FDA #5-40 .
- . HIPAA Compliant, FDA #None
10. Technological Characteristics
The main differences between Motion Intelligence, Inc.'s ClearEdge Balance System, Model 1055, and the Predicate Devices the Sway Balance System cleared under K121590 are the following:
- The ClearEdge Balance® System measures postural sway with a proprietary sensor located at a person's ● center of mass, midline at approximately L5, while the Sway Balance system measure postural thoracic sway, using the built-in motion sensors of any iOS device.
- . The Sway Balance System is a mobile application that must be downloaded and run on an iOS mobile device that is supplied by the end user. The ClearEdge Balance System provides The Edge Sensor, friction pad, and balance pad to the end user and requires a mobile application that must be downloaded and run on an COTS Android device.
- . ClearEdge Balance System provides the Edge Sensor to measure the patient's balance. Sway Balance System relies on the accelerometer provided in iOS mobile operating devices.
- . ClearEdge Balance System and Sway Balance System use different methods in comparing the results on a series of balance stances. According to the predicate's public clearance records, Sway provides a comparison of raw scores on each balance stance and a comparison of test score against patients' average score. ClearEdge Balance provides a comparison of raw scores on each balance stance, and a comparison of raw scores on each balance stance overlaid with threshold lines representing the Minimal Detectible Change (MDC) for that test.
Other minor differences between ClearEdge Balance System and the Sway Balance System predicate also include:
- The ClearEdge Balance System provides the user with some of the hardware that is needed to use the system ●
- ClearEdge Balance System uses the Android operating system; Sway Balance System uses Apple's iOS
- ClearEdge Balance System uses a tablet; Sway Balance System uses smartphones or tablets.
- . The ClearEdge Sensor is powered by 3 AAA batteries, and the Sway Balance System uses the iPhone's lithium ion battery
11. Comparison Table
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| Feature | ClearEdge Balance SystemModel 1055(System Under Review) | Sway™ Balance System(Cleared under K121590) | Comments | |
|---|---|---|---|---|
| FDARegulation,Number,Product Code& Description | Unclassified, LXV, Apparatus, Vestibular Analysis | Unclassified, LXV, Apparatus, Vestibular Analysis | Same. | |
| Intended Use | The ClearEdge® Balance System is a mobile softwaresystem that analyzes balance through postural sway. TheSystem is comprised of application software andaccessory hardware, consisting of a mobile computingdevice, proprietary sensor, balance pad, and friction pad.The System measures the amount of motion of asubject's center of gravity, while the subject attempts tomaintain various body posture stances, and translates theamount of motion into a numeric score. | The Sway™ Balance System is a mobile measurementsystem that analyzes balance through thoracic sway,using the built in accelerometer of a mobile device. TheSway Balance System is a stand-alone mobile operatingsystem software application that does not include anyperipheral hardware add-ons. | Both devices are mobile measurement systems thatanalyzes balance through either postural (proposed) orthoracic (predicate) sway. Both devices measure theamount of motion of a subject while maintaining a bodyposture stance and translate the amount of motion into ascore that represents balance. The difference inmeasuring the type of sway is a function of where thesensor/accelerometer is physically located. The subjectdevice places the sensor on the subject's lower back,while the predicate device is held against the chest. Thesubject device uses a proprietary sensor with a built-inaccelerometer while the predicate device uses the iPhone'saccelerometer. Neither of these issues raise new questionsof safety of effectiveness. | |
| Indication forUse | The ClearEdge® Balance System is intended for use toassess sway as an indicator of balance. Individualsuitability for assessment must be judged on a case bycase basis, by a qualified individual including thosecertified and/or licensed in their state to prescribe and/oruse balance devices such as certified athletic trainers.physical therapists, chiropractors, nurses and physicians.The ClearEdge® Balance System can be used wherevercompatible Android mobile operating devices can beused. | The Sway™ Balance System is intended for use to assesssway as an indicator of balance. Individual suitability forassessment must be judged on a case by case basis, by aqualified individual including those certified and/orlicensed in their state to prescribe and/or use balancedevices such as certified athletic trainers and coaches,physical therapists, nurses and physicians. Conditionsaffecting postural sway include nausea, headache,orthopedic injury, ear infection, medications, head injury,dehydration and fatigue. The Sway™™ Balance Systemcan be used wherever an iOS mobile operating device isavailable. | Both devices measure acceleration and motion andconvert the measurements into a numeric balance scorebetween 0 and 100, and both devices have the sameintended users and use environments. | |
| Intended User | Certified athletic trainers, physical therapists, nurses,chiropractors, and physicians who are licensed toprescribe and/or use balance devices. | Certified athletic trainers and coaches, physicaltherapists, nurses and physicians who are licensed toprescribe and/or use balance devices. | Same intended users. | |
| Intended UseEnvironment | Anywhere mobile devices can be utilized | Wherever an iOS mobile operating device is available | Both devices use mobile platforms. | |
| Target PatientPopulation | Athletes. Patients with balance issues | Athletes. Patients with balance issues | Same targeted patient populations. | |
| Contraindications | Contraindications:Improper TestingUnstable SurfacesWet or Slippery SurfacesCluttered Environments | Contraindications:Improper TestingUnstable SurfacesWet or Slippery SurfacesCluttered Environments | Same contraindications. | |
| Feature | ClearEdge Balance SystemModel 1055(System Under Review) | Sway™ Balance System(Cleared under K121590) | Comments | |
| Uselimitations | Improper environment may lead to inaccurate results orcause harm to the patientA patient with an injury should not be tested, but insteadgiven medical attentionIndividual suitability for assessment must be judged on acase by case basis, by a qualified individual includingthose certified and/or licensed in their state to prescribeand/or use balance devices | Improper environment may lead to inaccurate results orcause harm to the patientA patient with an injury should not be tested, but insteadgiven medical attentionIndividual suitability for assessment must be judged on acase by case basis, by a qualified individual includingthose certified and/or licensed in their state to prescribeand/or use balance devices | Identical use limitations. | |
| System-LevelComponents | The ClearEdge® Balance System is a mobilemeasurement system that analyzes balance throughpostural sway. As shipped, the ClearEdge BalanceSystem includes: the Edge Sensor- a proprietary sensor, aFriction Pad, a Balance Pad, and a Carrying Case.The user must download the software onto an approvedtablet | The Sway Balance System is a software solution thatutilizes the hardware of the Apple iOS mobile operatingsystem for products such as the iPhone 3G, 3G5, 4, 4S,iPad, iPad2 and iPod Touch. The built in accelerometerof these devices is accessed to analyze motion during abalance test. | Fundamentally, both systems are software programs thatrequire the user to provide the operating platform. Bothhave the same/equivalent components and offering someof the needed hardware components as part of the systemdoes not raise and new questions of safety oreffectiveness. | |
| AdditionalRequiredComponents | The ClearEdge® Balance System requires the user toprovide a tested and approved Android tablet, a stylet(for data input) and headphones (for use with the tablet) | Sway Balance System requires the user to provide anApple iOS mobile device | The ClearEdge Balance System requires the user todownload the software onto an Android tablet, a mobiledevice, while the Sway balance system requires the userto download the software onto an iPhone, also a mobiledevice. | |
| TestingMethods | The ClearEdge Balance System tests for balance byutilizing the Edge Sensor to measure acceleration andmotion. The Edge Sensor is attached to a subject with abelt, located over the lower back, which is near theanatomical center of mass. | Using the built-in motion sensors of any iPhone, iPad oriPod Touch* device and Sway's mobile application,health professionals can administer a medical gradeobjective balance test in virtually any setting. | Both devices measure balance using an accelerometerwhich is then displayed on a mobile device. Thedifferences in accelerometers (proprietary versus iPhone)and platform (Android versus iOS) does not raise newquestions of safety or effectiveness. | |
| TestingProtocol | The ClearEdge Balance System tests eight differencebalance stances, while measuring postural sway with aproprietary sensor located at a person's center of mass,midline at approximately L5. The stances include acombination of feet together stance, tandem stance, eyesopen, eyes closed, on a firm surface, and on the balancepad provided in the system. | To administer a test, an athlete or patient is instructed topress the mobile device against their chest with bothhands, while performing a five-test protocol that includesa combination of bipedal (feet together) stance, tandemstance and single leg stance positions. Sway measuresthoracic postural sway using the built-in motion sensorsof any iOS device to estimate balance. | Both testing protocols are based on balance stances.Although there are slight variations in implementation,the basis of the stances for each device is fundamentallysimilar. Both devices measure sway via accelerometers.The Edge Sensor is placed at a person's center of mass tomeasure postural sway and Sway Balance places an iOSdevice at a person's chest to measure thoracic posturalsway. The differences do not raise any new questions ofsafety or effectiveness. | |
| Scoring/Results | The ClearEdge Balance System recommends eachindividual complete a baseline test for post eventcomparison since individual balance will vary person toperson.For each of the balance stances, the Edge Sensormeasures the patient's postural sway using anaccelerometer at 250 packets/second. For each test, thepatient's relative motion is converted to a balance score | The Sway score is intended to provide an individualizedbaseline of each athlete or patient's own ability tomaintain postural control during the testing conditions.Balance scores vary for each individual and should becompared to each individual's "normal" baseline.Sway Balance reports balance scores on 0 to 100 scalefor each individual tests. A composite score is reported, | Both devices recommend each individual complete abaseline test since postural balance will vary for eachindividual. Both systems report the balance result on a 0-100 scale, reporting the scores for each individual tests,as well as a composite average score.Both devices use known statistical methods to evaluatethe balance scores that they compute in a similar manner.These methods of statistical analysis are well known and | |
| ClearEdge Balance SystemModel 1055(System Under Review) | Sway™ Balance System(Cleared under K121590) | Comments | ||
| Feature | on a 0 to 100 scale with a higher number representingless motion and a lower number representing moremotion.ClearEdge Balance is used to track changes in balancescores over time. Comparisons between the ReferenceTest and each Comparison Test are based on adetermination of whether the difference between theReference Test scores and Comparison Test scores(Difference Scores) are large enough to representdifference in performance. A Minimum DetectableChange (MDC) is used to determine the threshold size ofa Difference Score that must be present to be deemedsignificant at a prescribed statistical confidence level. | which is calculated by averaging the patient's individualscores for each of the five balance tests. | the differences in analytic comparison of balance scoresdo not raise any questions of safety or effectiveness.Reference Device KOREBALANCE TM, K070676, formonitoring over time, "Quantitative measurement ofpatient balance performance while the patient executes apreprogramed set of maneuvers or protocols... Thepatient results are scored and saved (the information isnot a clinical measurement but provides a reproduciblequantitative measurement that the therapist can use toplan and monitor therapy)...in conjunction with thetherapist's observations, to assess patient progress overthe course of multiple...sessions." | |
| Power Source | Edge Sensor requires 3 AAA batteriesThe mobile device operates on lithium ion rechargeablebattery | Mobile device operates on lithium ion rechargeablebattery | Both devices operate on battery power. The type ofbattery (AAA versus lithium ion) does not raise any newquestions of safety or effectiveness. | |
| Device Type | Sensor with accelerometer | iOS mobile device with accelerometer | Nearly identical outputs and performance, other than | |
| Measurement | Kinetic energy/balance | Kinetic energy/balance | marketing approaches that do not raise any questions ofsafety or effectiveness. | |
| DeliverySystem | Results shown on mobile device or other web capabledevice | Results shown on mobile device or other web capabledevice | ||
| PatientContact/Interface Materials | Mobile device, Edge Sensor | Mobile device | Nearly identical patient contact/interface methods.Including a separate motion sensor is done for improveduser experience. Doing so raises no new questions ofsafety (no new biocompatibility issues) or effectiveness. | |
| HardwareSpecifications | Tablet | Hardware of the Apple iOS mobile operating system forproducts such as the iPhone 3G, 3G5, 4, 4S, iPad, iPad2and iPod Touch. | Nearly identical hardware specifications. | |
| MobileOperatingSystem | Android | iOS | Mobile operating systems are similar and the differencesbetween Android and iOS in this application do not raiseany questions of safety or effectiveness. | |
| User InputMechanism | Stylus | Unknown | Similar User Input Mechanisms. | |
| Display | Tablet | iPhone 3G, 3G5, 4, 4S, iPad, iPad2 and iPod Touch. | Nearly identical display. | |
| Dimensions | Case dimensions: 4 3/4" h x 16 1/2"w x 20 7/8"l | Software only (the hardware is provided by the iPhone,but was excluded from consideration in their 510(k)application) | ClearEdge has provided some hardware componentsneeded for ease of the customers and marketingpurposes. There are no questions of safety to the patient | |
| Weight | Under 15 lbs. | N/A (the hardware is provided by the iPhone, but wasexcluded from consideration in their 510(k) application) | ClearEdge has provided some hardware componentsneeded for ease of the customers and marketingpurposes. There are no questions of safety to the patient | |
| ClearEdge Balance SystemModel 1055(System Under Review) | Sway™ Balance System(Cleared under K121590) | Comments | ||
| Feature | OperatingEnvironment | Normal environment where the temperature andhumidity are maintained for normal human comfort. | Information not available, but assumed to be normalenvironment where the temperature and humidity aremaintained for normal human comfort. | Within reasonable assumptions, the operatingenvironments are the same. |
| StorageEnvironment | Store in a dry location between 0°C / 32°F and 45°C /113°F. Do not store items in direct sunlight.All items should be stored in their designated space inthe ClearEdge Balance System storage case | Software only, no storage required (the hardware isprovided by the iPhone, but was excluded fromconsideration in their 510(k) application) | ClearEdge has provided some hardware componentsneeded for ease of the customers and marketingpurposes. There are no questions of safety to the patient. | |
| Standards | Technical / Product-Related Standards:• IEC 60601-1:2012 Ed 3.1 General requirements forbasic safety and essential performance• IEC 60601-1-2:2014 Ed 4 Medical electricalequipment - Part 1-2: General requirements for basicsafety and essential performance - Collateral Standard:Electromagnetic disturbances - Requirements and tests• IEC 60601-1-6 Issued: 2013/10/29 Ed: 3.1 MedicalElectrical Equipment - Part 1-6: General Requirementsfor Basic Safety and Essential Performance -Collateral Standard: Usability• IEC 60601-1-11 Issued: 2015/01/20 Ed. 2 MedicalElec. Equip.- Part 1-11: Gen. Req. for Basic Safety &Essential Performance - Collateral Standard - Req. forMedical Elec. Equip. & Medical Elec. Systems Usedin the Home Healthcare Environment• IEC 60529:2013 Degrees Of Protection Provided ByEnclosures (IP Code), FDA #None• 47CFR Part 15 Federal Communications Commission(FCC)• ISO 15223-1:2012 Medical devices - Symbols to beused with medical device labels, labelling andinformation to be supplied - Part 1: GeneralrequirementQuality System, Risk Management & Process-RelatedStandards: | The Sway Balance™ System is a software only solutionthat utilizes the hardware of the Apple iOS mobileoperating system for products such as the iPhone 3G,3G5, 4, 4S, iPad, iPad2 and iPod Touch. The built inaccelerometer is accessed to analyze motion during abalance test.Note: With the above in mind, it is assumed that SwayBalance did NOT consider the iPhone be a medicaldevice (even though the their SW platform is completelydependent on the iPhone's accelerometer) and did notconduct any electrical safety / EMI testing. | The proposed device was designed and testing accordingto the applicable standards, importantly including testingto IEC 60601-1-2, 4th edition for EMC compatibility in a"home use" environment. The predicate devices did not.However, ensuring compliance does not raise questionsof safety. | |
| Feature | ClearEdge Balance SystemModel 1055(System Under Review) | Sway™ Balance System(Cleared under K121590) | Comments | |
| • IEC 62366 Issued: 2014/01/28 Ed. 1.1 Medical Devices - Application of Usability Engineering toMedical Devices• IEC 62304:2006 Medical device software - Software life cycle processes• ISO 14971:2012 Medical devices - Application of risk management to medical devicesHIPAA Compliant |
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12. Performance Testing; Laboratory and Human Performance:
Equivalence between ClearEdge Balance assessment of balance was demonstrated by Laboratory Testing and supplemental human performance testing. Laboratory Testing compared Clear Edge Balance scoring of movements of an inverted pendulum. Correlation of ClearEdge Balance and Sway Balance scores were evaluated using regression. Linear regression: r values for all tests were greater than 97, and the slopes of the liners regression in the tests ranged between 92 and 1.05 (p<.00). Deming regression: 95% confidence interval for slope contains the value 1. 95% confidence interest contains the value 0. Supplemental clinical testing compared ClearEdge Balance and Sway Balance sores for 34 subjects on Sway Balance tests (Power > 80%) using a Two One Sided Test Procedure (TOST). The upper end of the 90% onfidence interval for the difference between means of ClearEder scores (Confidence Interval) was less than the upper end of the equivalence margin (r<.00)), and the lower end of the Confidence Interval was greater than the lower end of the equivalence was demonstrated because the Confidence Interval is contained within the equivalence margin.
Laboratory Testing Summary:
The driving force of the inverted pendulum can be adjusted in frequency and amplitude. The following figure shows the available input frequences and annlitudes. The blue area represents the available of frequency and amplitude, and the dots represent the actual frequency and amplinde that produced one of the sets of data.
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Image /page/10/Figure/0 description: The image is a plot titled "Inverted Pendulum Driving Force Characteristics". The plot shows the amplitude of driving force in m/s^2 on the y-axis versus the frequency of driving force in Hz on the x-axis. The plot shows a blue shaded region labeled "Usable Driving Force Space" and a scatter plot of black dots labeled "Actual Freq & Amp for Sway & CE Score".
These data only represent the input driving force, the sensors the spectrum of motion as an output and convert that to a score.
A simple model of human standing is given by an inversional, classical model for the motion of a single, massive particle. A standing human is approximated as a single mass (located at the center of mass) separated from the ground by a massless rod of fixed length L. The feet are treated as attached to the ground by a fulcrum, such that the center of motion along an arc of radus I around the feet---- hus the mechanics of the system are described by the tilt angle 0, representing the center of the center of mass from directly above the feet, with the rod positioned normal to the ground.
In quet standing, a subject uses and hip muscles to change the center of pressure necessary to keep changes in the center of mass over the area of the ground in contact with the feet. The center of pressure is located at various possions in the soles of the feet in conact with the ground. The ankle muscles are used to generate of pressure to control changes in the center of mass in the anterior - posterior direction and
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the hip muscles are used to generate changes in the center of mass in the center of mass in the medial – lateral direction. The difference in the center of pressure and the center of gravity at any time motion and acceleration of the center of mass in the horizonal plante (anteriorposterior and medial-lateral directions). The difference between conter of pressure is the control system used by the numan balance control system. See Winter, D. A. (1995). Human balance and posture control during standing and walking. Gair & Posture, 3(4). 193-214. The motion and accelection in the horizonal plane is mathematically related to the axis between the center of mass and the ground. The pendulum model therefore is an accurate representation of the body to maintain the standing posture. The pendulum is perfectly balanced when the mass is possioned directly above the pivot power, a very slight displacement of the mass from this position will cause the pover.
Humans can overcome this difficulty and maintain balance, at which the system is at equilibrium, by mantaining active control of their center of mass relaive to the fulcrum formed by the makes work to exet a torque that counteracy gravity and prevents the individual from falling over. The timesale that this recover equilibrium is proportional to the period of a simple pendulum.
demonstrated as T = 2π
Precise measurements of active balancing can be madividual standing, and digitally tracking the location of the center of mass after the individual is tilted forward by a known angular displacement at =0.
Supplemental human performance testing summary:
Supplemental human performance to confirm the substantially equivalent balance scores generated by Sway and CE Balance in the laboratory testing performed on the inverted performance testing. This supplemental human performance testing onsisted of using Sway and CE Balance simultaneously to generate balance sores on 34 subjects who were tested on the five Sway balance stances. 29 subjects were healthy and 5 had some neurologic condition.
The balance scores generated by Sway and ClearEder on all five Svar stances were combined for comparison. The results of all stances were combined because the Sway predicate reports an aggregate sombined and the laboratory testing comparing Sway and ClearEdge demonstrated that their respective balance scores were highly correlated across all ranges of motion. The comparison of Sway and ClearEdge on the human performance testing was done using a Two One Sided Test (TOST).
The TOST compares the difference between the mean ClearEdge soores on all stances on all stances in relation to an equivalence margin. The equivalence margin was set +10 to -10, because that the effect size due to the equivalence margin would be significantly less (.4) than the standard deviation of the difference scores.
The TOST compares the difference between Sway and Clear equivalence margins using at statistic. The TOST t statistic is computed for each margin by subtracting ±10 from the difference between means of the Sway and dividing the result by the pooled standard deviation of the difference scores. The two t statistics are then determined from the appropriate t distribution.
- The significance level for the p values necessary to show alence for the TOST was set at .05, which demonstrates that the ● confidence interval around the difference in Sway and ClearEdge means at the 90% level of the equivalence margin. The p values for the human performance TOST were .0008 for the lower equivalence margin and .00007 for the upper equivalence margin, which satisfied the condition to demonstrate substantial equivalence.
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13. Summary of MDC Development
The Minimal Detectible Change (MDC) for each of the eight stances used in ClearEdged with a test-retest repeatability study, in which 144 subjects were tested on two occasions separated by short periods of time (most time intervals between the two test were less than 50 days). 109 subjects were healthy and 35 had time study only if the study only if they had no injury or change in symptoms between the two tests.
The difference between each subject's score on the two test occasions were calculated and the difference scores were found to be normally distributed for each stance used in the Clearling, which is a condition to use of the MDC to define the boundaries of expected variation in results on a repeated test.
The MDC is the size of a change in balance score that is a change in performance and not measurement error and normal hunan variation. The measurement error of ClearEdge Balance was deemined the Standard Error of Measurement (SEM) statistic. The MDC was calculated for the 9% confidence level; which is the size of a change in bas only a 5% probability of being caused by measurement error. The MDC is proportional to the SEM (1.96 x 12 x SEM for the 95% confidence level). Numeric values for the SEM and MDC differ for each balance stance, but the MDC for each test represents the threshold for separating real chance stance from measurement error at the 95% confidence level.
14. Comparison Summary / Conclusion
The proposed ClearEdee Balance System (Model 1055) and its predicate device, the Swar under K121.590 share the same intented use, intended users, intended use environment and indications the proposed devices and the predicate systems have the samelequivalent technological characteristics and safety standards, user interfaces, contraindications and applicable standards. The differences that exst between the devices, relating to their mobile over, physical size, and weight and appearance do not affectiveness. Thus, the proposed Clearling System (Model 105) and its predicate device, the Sway Balance System cleared under K121590, are substantially equivalent.
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