A software system used with the Microsoft Kinect intended to support repetitive task practice for rehabilitation of adults under supervision of a medical professional in a clinical or home setting. The system includes simulated activities of daily living (ADLs) for the upper extremity with audio-visual feedback & graphic movement representations for patients as well as patient performance metrics for the medical professional. Patient assessment, exercise guidance, and approval by the medical professional is required prior to use.

Device Description

The VOTA software system comprises a VOTA patient-facing and a provider-facing Provider Dashboard. The VOTA patient-facing application supports repetitive task practice exercises for the upper extremity that are consistent with Standard of Care for physical rehabilitation of adults. The software runs on a personal computer under the Windows 8.1 operating system (or later) and uses a Microsoft Xbox One Kinect Sensor (hereafter referred to as Kinect Sensor) to track patient arm movements. These arm movements are translated into equivalent movements of a graphical avatar that represents the patient in a virtual environment. The patient is thus able to practice activities of daily living (ADLs) that involve meaningful tasks and evoke functional movements with graduated levels of difficulty. The activities are organized into a virtual "Road to Recovery" that traverses a series of four islands, each organized around a central theme. There is no physical contact between the patient and the device during exercises, and thus no energy is directed to the patient assessment by a medical professional, and selection of exercise and settings, is required prior to use.

The provider-facing VOTA Provider Dashboard application enables the medical professional to view patient performance metrics and participation history using data produced by the VOTA patient-facing application. The application runs on the same personal computer and operating system as the patientfacing application.

All hardware associated with VOTA are commercial-of-the-shelf, consumer hardware items. The VOTA system ships with the following:

Microsoft Xbox One Kinect Sensor and Kinect power supply;
Microsoft Xbox Kinect Adapter for Xbox One ;
Kinect TV Mount for Xbox One;
Personal computer (preloaded with VOTA software) and computer power supply;
Wireless keyboard;
HDMI cable;
Getting Started Guide; and
Third-party Labeling Package

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Virtual Occupational Therapy Application (VOTA). However, it does not contain a specific table of acceptance criteria nor a detailed study that proves the device meets specific acceptance criteria in the way typically seen for a new AI/ML drug or device submission with quantifiable performance metrics (e.g., sensitivity, specificity, accuracy).

The document focuses on demonstrating substantial equivalence to a predicate device (Jintronix Rehabilitation System (JRS)) by comparing intended use, technological characteristics, and safety characteristics, rather than establishing quantifiable performance acceptance criteria for VOTA itself. The clinical testing described is primarily to show effectiveness for rehabilitation, not to meet pre-defined, quantitative performance metrics for a diagnostic or assistive AI system.

Therefore, I will extract and synthesize the information available in the document regarding the device's performance, the type of testing conducted, and the evidence provided to support its safety and effectiveness relative to its intended use and predicate device. I will then explain why some requested information (like specific quantitative acceptance criteria and AI-specific study details) is not present in this type of submission.

Here's the closest representation of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of quantitative acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy, as would be typical for an AI/ML diagnostic or predictive device. Instead, the "acceptance criteria" are implied through the demonstration of substantial equivalence to a predicate device and clinical usability/effectiveness for its intended rehabilitative purpose.

The "performance" is primarily assessed in terms of clinical effectiveness for rehabilitation and safety.

Implied "Acceptance Criteria" Category	Description / Reported Performance
Functional Gain / Clinical Effectiveness	Acceptance Implied by: Demonstration of clinically significant improvement in upper extremity (UE) motor performance. Reported Performance: Stroke patients (n=15) using VOTA for ~1 hour, 3 times/week, over 8 weeks (24 total sessions) achieved an average Fugl-Meyer UE (FMUE) improvement of 6 points. This was measured pre- and post-intervention using the FMUE, a widely-recognized and clinically-relevant measure.
Safety	Acceptance Implied by: Absence of adverse events, compliance with safety standards, and no unique safety concerns compared to predicate. Reported Performance: No adverse incidents or injuries were reported over the entire period of actual VOTA use by stroke patients in the clinical testing, spanning 240 total sessions of approximately 1 hour each. The device also complies with consumer electrical safety standards (e.g., UL) and laser Class 1 standard (IEC 60825-1:2007) for the Kinect sensor. The risk analysis (ISO 14971) indicated a "Moderate Level of Concern" due to a small, non-zero risk of minor injury from overexertion if incorrectly used, which is mitigated by medical professional supervision as stipulated in the Indications for Use.
Usability	Acceptance Implied by: Assessment using a widely-accepted instrument and systematic comparison to Standard of Care by licensed therapists. Reported Performance: Clinical testing included "assessment of usability using a widely-accepted instrument" and "systematic comparison of VOTA to Standard of Care by licensed therapists." (Specific scores or detailed results are not provided in this summary).
Accuracy of Tracking	Acceptance Implied by: Sufficiency of Kinect-based tracking for intended application and established literature. Reported Performance: Clinical testing "demonstrated that VOTA's Kinect-based upper extremity tracking produces valid results for the intended application." The Kinect-based tracking solution was found to be "sufficient, both to permit patients to successfully perform virtual ADL exercises and to support derivation of speed-based motor performance metrics." References were provided for existing literature demonstrating the accuracy of Kinect-based upper extremity tracking.
Functional Equivalence	Acceptance Implied by: Demonstration that core functionality aligns with predicate and supports Indications for Use. Reported Performance: Bench testing validated "the core functionality of the software system" and established "substantial equivalency to the Predicate." Traceability was provided between Indications for Use, system-level requirements, test plans, and documented test results showing success criteria are met.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: 15 stroke survivors with upper extremity impairment participated in the clinical testing.
Data Provenance: The clinical testing was conducted by the University of Virginia (UVa) Department of Physical Medicine and Rehabilitation and the UVa HealthSouth Rehabilitation Hospital under the approval and governance of the UVa Institutional Review Board for Human Subject Research (IRB-HSR). This indicates prospective data collection from a specific clinical setting in the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not explicitly stated as a distinct "ground truth" expert panel in the document. The clinical study involved:
- Licensed occupational therapists who supervised the sessions.
- Experienced therapists who assessed safety (over 200 hours of actual patient contact time using the VOTA system).
Qualifications of Experts: Licensed occupational therapists; experienced therapists (implied clinical background). The Fugl-Meyer UE assessment (FMUE) is a gold-standard, clinician-administered test, meaning the scores collected by the trained therapists serve as the "ground truth" for motor performance.

4. Adjudication method for the test set

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth for the test set. For the FMUE assessment, it is a standardized clinical measure typically administered by a single trained therapist for each assessment. Inter-rater reliability (if multiple therapists assessed the same patient) or a consensus process is not mentioned.

5. 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 comparative effectiveness study, as typically understood for evaluating AI assistance for human readers/clinicians, was not performed. This device is a direct patient-facing rehabilitation tool with a clinician supervising, not a diagnostic AI system assisting human interpretation of images or other data. The study was a clinical trial evaluating the therapeutic effect of the device on patients.

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

This device is not a standalone diagnostic algorithm. It is a patient-facing application that requires human-in-the-loop (medical professional supervision) as stated in its Indications for Use: "under supervision of a medical professional" and "Patient assessment, exercise guidance, and approval by the medical professional is required prior to use."
The "standalone" performance closest to what might be considered is the accuracy of the Kinect-based tracking (which is an algorithm within the system). The document states this tracking "produces valid results for the intended application" and was "sufficient" for performing exercises and deriving metrics, citing clinical testing and existing literature. This implies an internal validation of the tracking component, but not as a separately defined "standalone" study in the context of an AI-only performance claim.

7. The type of ground truth used

The primary "ground truth" for evaluating the device's effectiveness was clinical outcomes data – specifically, pre- and post-intervention scores from the Fugl-Meyer UE (FMUE) assessment. This is a clinician-administered, standardized functional outcome measure.
For safety, the "ground truth" was observation of adverse events/injuries by supervising therapists.
For tracking accuracy, the ground truth was implied by the ability of patients to successfully perform virtual activities and the feasibility of deriving motor performance metrics, supported by existing literature on Kinect accuracy.

8. The sample size for the training set

The document does not specify a sample size for a training set for the VOTA software. This type of submission (for a device like VOTA based on existing technology like Kinect and established rehabilitation principles) is focused on demonstrating substantial equivalence and clinical effectiveness, not on detailing the dataset used to train a novel AI/ML algorithm from scratch. While VOTA is software, it's not described as a deep learning or AI model requiring a large training dataset in the typical sense of current AI medical devices. It utilizes an off-the-shelf sensor (Kinect) whose core tracking algorithms were developed by Microsoft.

9. How the ground truth for the training set was established

Since a "training set" for a novel AI/ML algorithm is not described, the method for establishing its ground truth is also not applicable/not provided in this document. The "ground truth" relevant to VOTA's performance is established in its clinical test set, as described in point 7.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 28, 2017

Barron Associates, Inc. Bruce G. Wilson Business Manager 1410 Sachem Place, Suite 202 Charlottesville, Virginia 22901

Re: K163245

Trade/Device Name: Virtual Occupational Therapy Application (VOTA) Regulation Number: Unclassified Regulation Name: Unclassified Regulatory Class: Unclassified Product Code: LXJ Dated: February 1, 2017 Received: February 2, 2017

Dear Mr. Wilson:

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.

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 device

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael J. Hoffmann -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K163245

Device Name

Virtual Occupational Therapy Application (VOTA)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Submitting Organization and Owner 5.1

Name:	Barron Associates, Inc.
Address:	1410 Sachem Place, Suite 202Charlottesville, VA 20191
Phone:	(434) 973-1215
FAX:	(434) 973-4686
Regulatory Contact:	Bruce Wilson, Business Manager
Email:	wilson@barron-associates.com
Date of preparation:	16 November 2016

5.2 Device

Trade Name	Virtual Occupational Therapy Application (VOTA)
Model Number	VOTA-1.0
Common Name	Software system utilizing optical position recording for supportingrepetitive task practice for rehabilitation
Classification Name	System, Optical Position/Movement Recording
Review Panel	Physical Medicine
Product Code	LXJ
Device Class	Unclassified. VOTA is substantially equivalent to the predicate inProduct Code LXJ. The Product Code is identified as "Unclassified" inthe FDA database. Reason given is "Pre-Amendment." This informationcan be found at the flowing link:http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=LXJ

5.3 Predicate Device

Predicate Trade Name	Jintronix Rehabilitation System (JRS)
Model Number	Version 1.0
510(k) Number	K130847
510(k) Holder	Jintronix, Inc.
Device	System, Optical Position/Movement Recording

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Review Panel	Physical Medicine
Product Code	LXJ
Device Class	Product Code LXJ is Unclassified. Reason given is "Pre-Amendment."

Device Description 5.4

All hardware associated with VOTA are commercial-of-the-shelf, consumer hardware items. The VOTA system ships with the following:

Microsoft Xbox One Kinect Sensor and Kinect power supply;
. Microsoft Xbox Kinect Adapter for Xbox One ;
Kinect TV Mount for Xbox One;
. Personal computer (preloaded with VOTA software) and computer power supply;
Wireless keyboard;
HDMI cable;
Getting Started Guide; and
Third-party Labeling Package

VOTA Indications for Use Statement 5.5

A software system used with the Microsoft Kinetic intended to support repetitive task practice for rehabilitation of adults under supervision of a medical professional in a clinical or home setting. The system includes simulated activities of daily living (ADLs) for the upper extremity with audiovisual feedback & graphic movement representations for patients as well as patient performance metrics for the medical professional. Patient assessment, exercise guidance and approval by the medical professional is required prior to use.

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5.6 Substantial Equivalence with Predicate - Intended Use

The VOTA Indications for Use Statement is highly similar to that of the Jintronix Rehabilitation System (JRS) (hereafter referred to as "the Predicate"). The following is the Predicate's Indications for Use Statement with a strikethrough line showing the words eliminated, and underlined text is used to show words added to form the VOTA Indications for Use Statement.

A software system used with the Microsoft Kinect intended to be used to support the physical rehabilitation of adults in the clinic/ at home repetitive task practice for rehabilitation of adults under supervision of a medical professional in a clinical or home setting. The system includes rehabilitation exercises simulated activities of daily living (ADLs) for the upper extremity and trunk with audio-visual feedback & graphic movement representations for patients as well as remotely accessible patient performance metrics for the medical professional. Patient assessment, exercise quidance and approval by the medical professional is required prior to use.

Differences in Indications for Use Statements		Why differences do not affect safety andeffectiveness of VOTA when used as labeled.
VOTA	Predicate(s)
repetitive task practice forrehabilitation of adultsunder supervision of amedical professional in aclinical or home setting	the physicalrehabilitation ofadults in theclinic/ at home	Repetitive task practice is a more precise definitionof the element of standard of care implemented byVOTA. The clear statement that VOTA will be usedunder supervision reduces the VOTA risk profilecompared to the Predicate.
simulated activities ofdaily living (ADLs)	rehabilitationexercises	Simulated ADLs is a more precise definition of theway the VOTA system supports rehabilitation.Simulated ADLs are highly consistent with standardof care and at least as safe as the Predicate's moregeneric rehabilitation exercises.
Does not include "andtrunk"	Includes "andtrunk"	Does not adversely affect the safety or effectivenessof the device
Does not include"remotely accessible"patient performancemetrics	Includes"remotelyaccessible"patientperformancemetrics	Does not adversely affect the safety or effectivenessof the device

5.7 Technological Characteristics

VOTA device and the predicate have very similar technical characteristics. Both are software-based devices intended for the Windows operating system on a personal computer, and both use a Microsoft Kinect sensor for tracking patient upper extremity movements. Both translate movements to moving

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images on the display, along with audio-visual feedback. Both systems provide performance metrics for the medical professional. Both systems are non-invasive, do not contact the patient, and do not direct energy toward the patient. Both systems are non-sterile in their requirements. Neither system poses concerns over electrical, chemical, thermal or radiation safety. The following chart provides a substantial equivalence comparison.

Area ofComparison	Predicate	Applicant Device	Discussion
Principles ofOperation	This system allows amedical professional toassign movement activitiesto patients. It trackspatient movementproviding visual feedbackand reports on kinematicparameters like velocityand joint angular changesduring movement.	Same	No difference betweenVOTA and predicate.
Energy Usedand/ordelivered	As a software system,energy usage is low, andno energy is directed intopatient.	As a software system,energy usage is low, andno energy is directedinto patient.	No difference betweenVOTA and predicate.
Design	Per its 510(k) Summary,the Predicate systemrequires optical motionsensing technology andcomputer operatingsystem with Windows foroperation.	VOTA is a softwaresystem using MicrosoftKinect optical positionsensor and a Windowspersonal computeroperating systemplatform.	VOTA and the predicateemploy substantially thesame designconsiderations.
Materials /Technologyused	The Predicate in its 510(k)Summary identifies twosoftware modules, aMicrosoft Kinect opticalmotion capturecomponent and aMicrosoft Windowscomputer workstation.	VOTA is a softwaresystem using MicrosoftKinect optical positionsensor and a Windowspersonal computeroperating systemplatform.	VOTA and the predicateemploy substantially thesame materials andtechnology.
Biocompatibility	The Predicate in its 510(k)Summary notes that it hasno direct contact with	VOTA and itscomponents includingMicrosoft Kinect has no	VOTA and the predicatedo not come into contactwith the patient. Neither
	patient andbiocompatibility concernsare not applicable.	direct contact withpatient. Biocompatibilityconcerns are notapplicable.	presents biocompatibilitysafety concerns.
Compatibilitywith theenvironmentand otherdevices /SystemCompatibility	The Predicate in its 510(k)Summary notes that itssoftware and operatingsystem requirements havebeen validated, andsuitable changemanagement and designcontrols have beenimplemented.	VOTA is a softwaresystem using MicrosoftKinect and the Windowspersonal computerplatform. Together theyhave been validated tomeet designrequirements andconform to Standard ofCare for the intendeduse. AppropriateGMP/QSR designcontrols and changemanagement controlshave been implemented.	Both VOTA and itspredicate have beenvalidated as compatiblewith a Windows personalcomputer and MicrosoftKinect sensor.

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5.8 Safety Characteristics

The BAI-VOTA-SYS-003 Risk Analysis document (see Appendix E) describes the safety characteristics of VOTA, analyzed in accordance with ISO 14971 Medical Devices – Application of Risk Management to Medical Devices. This analysis informs the comparison to the predicate device that follows below.

Area ofComparison	Predicate	Applicant Device	Discussion
Electrical safety	The Predicate is asoftware device thatdoes not touch thepatient. Its electricalcomponents are apersonal computerand Microsoft Kinectsensor that thepatient does nottouch. Thesecomponents complywith consumerelectrical safetystandards such as UL.	VOTA is a softwaredevice that does nottouch the patient. Itselectricalcomponents are apersonal computerand Microsoft Kinectsensor that thepatient does nottouch. Thesecomponents complywith consumerelectrical safetystandards such as UL.	No differences in electricaltechnology and safety betweenVOTA and predicate.
Mechanicalsafety	As a software system,the Predicate does notutilize any mechanicalcomponents that thepatient touches.	As a softwaresystem, VOTA doesnot utilize anymechanicalcomponents that thepatient touches.	No differences in mechanicalsafety between VOTA andpredicate. There are nomechanical safety concerns ineither product.
Chemical safety	Not applicable to asoftware system.	Not applicable to asoftware system.	No differences between VOTA andpredicate. Chemical safety is notan issue that applies to eitherproduct.
Thermal safety	No issues of thermalsafety are identified inthe Predicate's 510(k)Summary.	VOTA is a softwaresystem that uses aWindows personalcomputer andMicrosoft Kinect.There are no knownsources of heatexcept a smallamount of warmthgenerated by thepersonal computer.	No differences between VOTA andpredicate. Thermal safety is notan issue that applies to eitherproduct. No adverse impact topatient safety.
Radiation safety	The Predicate usesMicrosoft Kinect thathas an infra-redsensor that per the510(k) Summarycomplies with laserClass 1 standard.	VOTA uses MicrosoftKinect that has aninfra-red sensor thatcomplies with thelaser Class 1 standardand IEC safetystandard 60825-1:2007.	No differences between VOTA andpredicate. No adverse impact tothe safety of patients using VOTA.
Sterility	The Predicate is anon-sterile productper the 510(k)Summary. It is asoftware system thatuses Microsoft Kinect.	VOTA is a non-sterileproduct. It is asoftware system thatuses MicrosoftKinect.	No differences between VOTA andpredicate. Neither is intended tobe a sterile product. No adverseimpact to the intended use.

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5.8.1 Level of Concern

The VOTA software system has a Moderate Level of Concern, which is the same as the Predicate. The rationale for the Moderate Level of Concern is that, prior to the mitigation of hazards, there is a small, but non-zero risk of Minor Injury (e.g. joint/muscle injury due to overexertion) for a patient if instructed to perform an inappropriate movement for the patient's specific therapy. This risk is

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mitigated by the supervision of a medical professional that is stipulated in the device's Indications for Use. Since the supervision of a medical professional is considered a control, we must assert a Moderate Level of Concern.

5.9 Summary of Testing

The VOTA software system has been extensively tested, including bench and clinical testing.

5.9.1 Bench Testing

Third-party bench testing of the VOTA patient-facing application was conducted to establish that the software system provides the capabilities necessary to support the product's Indications for Use. In addition to validating the core functionality of the software system, this testing also establishes substantial equivalency to the Predicate, which shares (nearly) identical indications.

Traceability has been provided between: (1) the VOTA Indications for Use Statement; (2) a core set of system-level requirements; (3) test plans (including rubrics and success criteria) to validate that these system-level requirements; and (4) documented test results showing success criteria are met. A major emphasis of bench testing is demonstration of the consistency of VOTA exercises with Standard of Care for occupational therapy. Therefore, a detailed explanation of Care is provided, along with linkages to test plans and results. Analysis of bench test results demonstrates that all success criteria are met.

5.9.2 Risk Controls

Verification of risk controls has been provided within the Device Hazard Analysis and the Risk Control Verification Plan. The results of third-party evaluations verifying the recommended controls are documented in the Risk Control Verification Report. All risk controls have been successfully verified by use of tests and/or demonstrations and/or document review and inspection, with traceability maintained between potential hazards and V&V results.

5.9.3 Clinical Testing

Clinical testing was performed to demonstrate and validate the accuracy of the device and repetitive tasks. Clinical testing of the VOTA system was conducted by the University of Virginia (UVa) Department of Physical Medicine and Rehabilitation and the UVa HealthSouth Rehabilitation Hospital under the approval and governance of the UVa Institutional Review Board for Human Subject Research (IRB-HSR). In the IRB-approved protocol, stroke survivors with upper extremity (UE) impairment were asked to attend three one-hour sessions per week over eight weeks (24 total sessions for each subject) in the Outpatient Clinic of the UVa HealthSouth Rehabilitation Hospital. In these sessions, the patients employed the VOTA patient-facing application to practice virtual activities of daily living (ADLs) to exercise their upper extremity in repetitive task practice, consistent with Standard of Care for occupational therapy. Licensed occupational therapists supervised the sessions. Rubrics and success criteria included: (1) establishing clinically significant improvement in pre-/post- functional gain using gold-standard measures of UE motor performance; (2) assessment of usability using a widely-accepted instrument; (3) systematic comparison of VOTA to Standard of Care by licensed therapists, and (4) assessment of safety by experienced therapists with over 200 hours of actual patient contact time using the VOTA system.

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Clinical testing demonstrated that use of VOTA is effective for supporting the rehabilitation of UE motor function, as measured by pre-/post- assessment using the Fugl-Meyer UE assessment (FMUE) - a widelyrecognized, accepted, and clinically-relevant measure of post-stroke functional impairment. Results of clinical testing demonstrated that stroke patients (n = 15, > 3 months since stroke, and no longer in rehabilitation outside of the study) using the VOTA system for approximately one hour, three times per week, over an 8-week period achieved an average FMUE improvement of 6 points. Additionally, there were no adverse incidents or injuries over the entire period of actual VOTA use by the stroke patients in the clinical testing spanning 240 total sessions of approximately 1 hour each. The results demonstrate that VOTA, used as intended for repetitive task practice, supports the rehabilitation of upper extremity motor function in stroke patients.

Clinical testing, published in peer-reviewed literature by the VOTA team, has demonstrated that VOTA's Kinect-based upper extremity tracking produces valid results for the intended application. The VOTA Kinect-based tracking solution was found to be sufficient, both to permit patients to successfully perform virtual ADL exercises and to support derivation of speed-based motor performance metrics. References have also been provided for existing literature demonstrating the accuracy of Kinect-based upper extremity tracking.

These results demonstrate that VOTA is as safe and as effective as the predicate device.

Regulation Number and Section

§ 890.5360 Measuring exercise equipment.

(a)
Identification. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.(b)
Classification. Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.