K-D Balance is an objective balance assessment tool and is intended to be used for individuals for whom a balance measurement is a desired outcome. K-D Balance is intended for use to assess balance performance. Individual suitability for assessment must be judged on a case by case basis, by a qualified individual including those certified or licensed in their state to prescribe and use balance devices including but not limited to athletic trainers and coaches, physical therapists, nurses, physicians, and other health care providers. Patients with could affect balance include, but are not limited to, vestibular dysfunction, nausea, headaches, orthopedic injury, inner ear infection or dysfunction, neurological conditions, head injury, medication side effects, dehydration and fatigue. K-D Balance can be used wherever an iOS mobile operating device is available. K-D Balance may only be used by health care professionals.

Device Description

K-D Balance is a mobile balance test to be used on the 6th generation iPhone or iPod touch with iOS versions 9.0 or later. K-D Balance measures balance using motion sensors already built-in to the iPhone or iPod touch devices. K-D Balance utilizes a proprietary algorithm that calculates a balance score based on the analysis of subject movements detected by the device's internal accelerometer. Balance is measured during a series of stances with the mobile device secured to the subject with a device holder. Health care professionals follow the step-by-step voice guidance that runs after launching the app during the entirety of the test to ensure consistency in obtaining balance measures. K-D Balance does not function as a diagnostic test, and K-D Balance results should be interpreted by healthcare professionals only.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the K-D Balance device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for performance metrics. Instead, the primary acceptance criterion appears to be statistical agreement with the predicate device (Sway Balance™) for balance outcomes in both normal and balance deficit groups, across various stances.

Acceptance Criteria (Inferred)	Reported Device Performance (K-D Balance)
Statistical agreement with predicate device (Sway Balance) for balance outcomes in normal subjects.	K-D Balance measures were in statistical agreement with Sway Balance outcomes for the normal group for the double leg, tandem right, and tandem left leg stances, according to linear regression analysis and Deming Regression Model. This supports substantial equivalence.
Statistical agreement with predicate device (Sway Balance) for balance outcomes in subjects with balance deficits.	K-D Balance measures were in statistical agreement with Sway Balance outcomes for the balance deficit group (including subjects with brain injury) for the double leg, tandem right, and tandem left leg stances, according to linear regression analysis and Deming Regression Model. Poorer balance scores were observed for subjects with balance deficits. This supports substantial equivalence.
Conformance to product specification (general).	K-D Balance met specification.
Sensitivity of the software to access data from the accelerometer.	Bench testing analyzed the sensitivity of the software to access data from the ST Microelectronics MEMS Accelerometer. Sensitivity scores with K-D Balance were comparable to the predicate.
Safety (no adverse effects or complications during or after testing).	No adverse effects or complications were encountered during or after performance testing.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 79 subjects (25 males, 54 females; mean age: 38.63 ± 12.88, range: 18-65).
- 34 subjects had brain injury or other neurological conditions (balance deficits).
- 45 subjects were non-injured (normal group).
Data Provenance: The study was conducted by the University of Texas, Southwestern Medical Center, Neurology and Sports Medicine Department. The data is prospective as testing was performed for the purpose of this device evaluation. The country of origin is the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This study does not appear to use human experts to establish "ground truth" in the traditional sense of diagnostic interpretation. Instead, the "ground truth" for balance performance is based on the objective measurements derived from the predicate device (Sway Balance™) and the clinical categorization of subjects (injured vs. non-injured).

The document mentions that the study was conducted by the University of Texas, Southwestern Medical Center, Neurology and Sports Medicine Department, implying medical professionals at that institution were involved in classifying subjects (e.g., identifying those with brain injury or neurological conditions). However, specific numbers or qualifications of individual experts for this categorization are not provided.

4. Adjudication Method for the Test Set

Not applicable. This was a comparative performance study against a predicate device and clinical categories, not an expert-driven adjudication of AI output. The "ground truth" for comparison was the predicate device's output and the subject's clinical status (injured/non-injured).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not explicitly described. This study focused on the performance of the K-D Balance device itself in comparison to a predicate device, not on how the K-D Balance assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance study was done. The performance testing directly evaluated the K-D Balance application's ability to measure balance and its statistical agreement with the predicate device (Sway Balance™). The balance assessment is performed by the application's algorithm, and the output is a score. Human involvement is in administering the test and securing the device, but the balance measurement itself is algorithmic.

7. The Type of Ground Truth Used

The ground truth for this comparison study was:

Objective measurements from a legally marketed predicate device: The balance scores generated by the Sway Balance™ application.
Clinical categorization: Subjects were categorized as "normal" or "balance deficit" (which included those with brain injury or other neurological conditions). Poorer balance scores were expected and observed in the deficit group, confirming the clinical relevance of the measurements.

8. The Sample Size for the Training Set

The document does not provide information regarding a specific training set size or how the K-D Balance algorithm was developed (i.e., whether it used a training set in machine learning terms). The description focuses on its proprietary algorithm and its use of motion sensors.

9. How the Ground Truth for the Training Set Was Established

As no training set is described, the method for establishing ground truth for a training set is not available in the provided text. The evaluation is focused on the device's performance against a predicate and clinical categories rather than a machine learning model's training process.

Summary

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April 2, 2018

King-Devick Technologies. Inc. Lori Grover Senior Vice President, Health Policy Two Mid America Plaza, Suite 110 Oakbrook Terrace, IL 60181

Re: K173669 Trade/Device Name: K-D Balance Regulatory Class: Unclassified Product Code: LXV Dated: February 27, 2018 Received: March 1, 2018

Dear Lori Grover:

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 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.

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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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely yours,

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173669

Device Name K-D Balance

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summarv

Trade Name	K-D Balance
Common Name	Balance Test Application
Classification	Unclassified
Product Code	LXV
Submitter	Lori Grover, OD, PhDKing-Devick Technologies, IncTwo Mid America Plaza, Suite 110Oakbrook Terrace, IL 60181Tel: (630) 501-0281Fax: 630-501-0285
Preparation Date	October 17, 2017 (revised March 30, 2018)
Predicate Device	Sway Balance ™ by Capacity Sports, LLC (K121590)

Device Description

Indication For Use

K-D Balance is an objective balance assessment tool and is intended to be used for individuals for whom a balance measurement is a desired outcome. K-D Balance is intended for use to assess balance performance. Individual suitability for assessment must be judged on a case by case basis, by a qualified individual including those certified or licensed in their state to prescribe and use balance devices such as certified athletic trainers and coaches, physical therapists, nurses, physicians, and other health care providers. Patients with conditions that could affect balance include, but are not limited to, vestibular dysfunction, nausea, headaches, orthopedic injury, inner ear infection or dysfunction, neurological conditions, head injury, medication side effects, dehydration and fatigue. K-D Balance can be used wherever an iOS mobile operating device is available. K-D Balance may only be used by health care professionals.

Technological Characteristics

K-D Balance and Sway Balance both run on iOS mobile devices. K-D Balance is compatible with 6th generation iPhone and iPod Touch. K-D Balance software will continually update to run on future generations of these iOS mobile devices. Sway Balance functions on iPhone 4, iPhone 5, 4th and 5thgenerations of iPod Touch, and iPads, according to the Sway Balance website (https://swaymedical.com/resources/faqs; last visited March 20, 2018).

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Both applications use built-in iOS mobile device accelerometers to calculate the output balance score. The output score reflects how much movement occurred during each assessment. Balance scores are measured on a 0 to 100 scale, and scores closer to 100 are considered closer to normal, with 100 being a perfect score. The point spread may vary between K-D Balance and Sway based on differences in algorithms, however the output scores are comparable and repeatable.

Performance Testing

Device testing was conducted to evaluate conformance to product specification. K-D Balance met specification. Performance testing verified that K-D Balance and Sway Balance System are in statistical agreement. Bench testing analyzed the sensitivity of the software to access data from the ST Microelectronics MEMS Accelerometer built into the mobile device that is compatible with the K-D Balance application. Sensitivity scores with K-D Balance were comparable.

Performance testing was completed by the University of Texas, Southwestern Medical Center, Neurology and Sports Medicine Department. K-D Balance testing were performed simultaneously (two trials) for a total of 79 male and female subjects (25 males, 54 females; mean age: 38.63 ± 12.88, range: 18-65) with and without brain injury or other neurological conditions (34 injured vs 45 non-injured). Balance measures were obtained for a total of three stances, which included the double leg stance, right tandem stance, and left tandem stance. The amount of movement, or sway, was calculated by each balance test application algorithm using data generated by the mobile device accelerometer. A device holder secured the iPhone 6 with K-D Balance and the subject held the other mobile device with Sway Balance.

K-D Balance measures were in statistical agreement with Sway Balance outcomes for both normal and balance deficit groups for the double leg, tandem right, and tandem left leg stances according to the linear regression analysis and Deming Regression Model. The statistical agreement between the two tests support substantial equivalence of K-D Balance to Sway Balance for double leg, tandem right, and tandem left leg stances. Poorer balance scores were observed for subjects with balance deficits, which included subjects with brain injury. No adverse effects or complications were encountered during or after performance testing.

Summary of Substantial Equivalence

K-D Balance proved to be substantially equivalent to the predicate application, Sway Balance System. Both applications assess sway during specific stances to generate an objective measure of balance. K-D Balance and Sway Balance utilize the same internal accelerometers built-into iOS mobile devices, and each contain proprietary algorithms within their software that calculates the output balance score. K-D Balance is a safe, effective tool in assessing balance performance in subjects who have balance difficulties or may be at-risk for balance issues.

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	Sway Balance ™	K-D Balance
IntendedUse	The Sway™ Balance System is intended toassess sway as an indicator of balance,particularly when screening for deviationsin postural sway as a possible symptom.The system is not intended to diagnose ortreat any medical condition or disease. It isdesigned to provide an affordable,convenient and portable screening tool forbalance assessment and should not replacean evaluation by a medical professional.(obtained from Sway's website:https://swaymedical.com/resources/faqs)	K-D Balance's intended use is to provide anobjective balance assessment utilized byhealth professionals in monitoring subjectbalance performance. K-D Balance is notintended to diagnose, screen, or treat amedical condition. K-D Balance functions asan iOS application that can be administeredquickly and easily.
Indicationfor Use	Individual suitability for use of the Sway™Balance System must be judged on a caseby case basis, by a qualified individualincluding those certified and/or licensed intheir state to prescribe and/or use balancedevices such as certified athletic trainersand coaches, physical therapists, nursesand physicians."Sway provides a portable outreachsolution for community concussionmanagement and fall risk screening toincrease referrals."The Sway Balance System can be usedwherever an iPhone 4, iPhone 5, 4th and5thgenerations of iPod Touch, and iPads areavailable.	K-D Balance is an objective balanceassessment for individuals who are underthe supervision of a health professional. K-DBalance testing should be performed on acase by case basis by a health professionalwith valid certification or licensure in thestate to prescribe or use balance devices.K-D Balance assessments can be useful inmonitoring balance performanceparticularly for conditions that impairbalance including: vestibular dysfunction,nausea, headaches, orthopedic injury, innerear infection or dysfunction, neurologicalconditions, head injury, medication sideeffects, dehydration and fatigue.K-D Balance can be used wherever a6th generation iPhone and iPod Touch orlater is available with or without an internetconnection.
TargetPopulation	Individual suitability for assessment mustbe judged on a case by case basis, by aqualified individual including those certifiedand/or licensed in their state to prescribeand/or use balance devices. Sway BalanceSystem is for concussion management andfall risk screening as well.	Individuals suitable for assessment must bejudged on a case by case basis by a certifiedand/or licensed health care provider. Healthprofessionals may use K-D Balance to assessbalance performance, but not to beinterpreted as a diagnostic test.
Where Used	The Sway Balance System can be usedwherever an iPhone 4, iPhone 5, 4th and	K-D Balance can be used wherever a6th generation iPhone and iPod Touch or
	5thgenerations of iPod Touch, and iPads are	later is available with or without an internet
	available.	connection.
Design	iOS mobile software application	iOS mobile software application
Materials	iOS mobile devices (iPhone 4, 5, iPod Touchand iPad 5)	iOS mobile devices (6th generation or lateriPhone and iPod Touch)
	The Sway Balance™ System is a softwareonly solution that utilizes the hardware ofthe Apple iOS mobile operating system forproducts such as the iPhone, iPad, and iPodTouch. The built-in accelerometer isaccessed to analyze motion during abalance test.	The built-in iOS mobile deviceaccelerometer is accessed to analyzemotion during the balance assessment. K-DBalance utilizes tri-axial coordinate datafrom the internal accelerometers of mobiledevices to determine a single quantitative,objective balance score throughmeasurements of pitch, yaw, roll and jerk.

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Regulation Number and Section

N/A