(249 days)
A software system used with the Microsoft Kinect v2 intended to support the physical rehabilitation of adults in the clinic and at home. The system includes rehabilitation exercises for the lower extremity with audio-visual feedback & graphic movement representations for patients as well as remotely accessible patient performance video. Patient assessment, exercise guidance and approval by a medical professional is required prior to use.
The Vera™ software utilizes three off-the-shelf accessories: a motion sensing camera, a monitor and a computer; to provide physical therapists and physicians with a software system to prescribe customized physical therapy plans for patients. Vera™ software provides medical professionals the tools to record video and track movements in three-dimensional space in order to identify motion and count repetitions during patient participation with a prescribed exercise. Data derived from motion tracking as well as the recorded video can be reviewed by medical professionals to assess exercise movements and adherence to the prescribed exercise; Vera™ is a software tool that helps extend that expertise. The Vera™ software has three separate applications: Patient Application, Clinician Application, and Server Application.
Here's an analysis of the acceptance criteria and study detailed in the provided document for the Vera device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Vera) |
|---|---|
| Correct Description of Exercises | 97.0% (223 out of 230 exercises) |
| Exercises recognized as typical for rehabilitation | 96.7% of therapists agreed |
| Therapists would recommend exercises to appropriate patients | 96.7% of therapists would recommend |
| Safety based on clinician review | Clinicians identified "universal risks" inherent in rehabilitation, not specific to Vera. No risks inherent to the device itself were explicitly identified, only those related to patient assessment and auxiliary equipment. |
| Accuracy of Vera in data processing | Validated by clinical study results "predominantly 100% exceeding the 95% acceptance criterion for all Vera activity movements." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 230 observations (10 Physical Therapists (PTs) x 23 Exercises/PT).
- Data Provenance: The study involved "healthy volunteers performing rehabilitation movements." The location of these volunteers or the study is not explicitly stated in the provided text. It is a prospective study as clinicians reviewed videos of performances.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: 10 Physical Therapists (PTs).
- Qualifications of Experts: The document explicitly states "Clinicians reviewed a series of video recordings." In a later section, it mentions "10 PTs," confirming the experts were Physical Therapists. No further details regarding their years of experience or specific sub-specialties are provided.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (such as 2+1 or 3+1). It describes that "Clinicians reviewed a series of video recordings... to verify that the movement seen in the video is recognized as physical therapy exercise and determine if they would recommend the movement to their patients." It appears each therapist made individual assessments, and the results were aggregated to report percentages of agreement. There is no mention of a process to resolve disagreements among the 10 therapists if they occurred.
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, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human readers' improvement with or without AI assistance was not performed. The study described focuses on clinician recognition and acceptance of exercises delivered by the Vera system, not on improving human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done?
The study described evaluates the "clinical relevance of exercises delivered by the Vera System" and whether movements "executed by an individual interacting with the system" are recognized as exercises by clinicians. This is not a standalone algorithm performance study. While the Vera system tracks movements and provides data, the core of this particular study is about clinician perception of the exercises facilitated by the system, rather than the raw algorithmic accuracy in isolation. The document states a "hazard analysis of the Vera™ software also indicates low risk to the end user" and that "Vera™ has been validated for accuracy / performance effectiveness both clinically and through software testing with appropriate change management and design controls," which may allude to some standalone testing, but the details of such are not provided for the clinical study section.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this specific study was expert consensus / expert opinion from the 10 Physical Therapists. They evaluated whether the movements performed by healthy volunteers via the Vera system were indeed recognized as physical rehabilitation exercises and if they would recommend them.
8. The sample size for the training set
The document does not provide any information regarding a training set size. This study appears to be a clinical validation of the exercises, not an evaluation of a machine learning model's training data. The Vera device itself is a "software system utilizing optical recording for rehabilitation exercises" and includes "motion sensing camera" technology (Kinect v2). While such a system internally would have trained algorithms for skeletal tracking and movement analysis, the details of that training are not part of the provided clinical performance data summary.
9. How the ground truth for the training set was established
As no training set is discussed in the context of this document's clinical performance section, the method for establishing its ground truth is not provided.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract image of a human face in profile, with three overlapping faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 30, 2015
Reflexion Health, Inc. Huan Tran Quality and Regulatory Manager 223 Broadway, Suite 650, San Diego, CA 92130
Re: K150462 Trade/Device Name: Vera Regulatory Class: Unclassified Product Code: LXJ Dated: 9/29/2015 Received: 9/30/2015
Dear Huan Tran:
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-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.
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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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of 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 yours,
Carlos L. Pena -S
Carlos Peña, PhD, MS 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) K150462
Device Name Vera
Indications for Use (Describe)
A software system used with the Microsoft Kinect v2 intended to support the physical rehabilitation of adults in the clinic and at home. The system includes rehabilitation exercises for the lower extremity with audio-visual feedback & graphic movement representations for patients as well as remotely accessible patient performance video. Patient assessment, exercise guidance and approval by a medical professional is required prior to use.
| 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
1. Owner Information
| Name: | Reflexion Health, Inc. |
|---|---|
| Address: | 225 West Broadway, Suite 650, San Diego, CA 92101 |
| Phone: | 619-202-4222 |
| Fax: | None |
| Contact | Huan Tran |
| Title: | Manager, Regulatory Affairs & Quality |
| Email: | huan@reflexionhealth.com |
| Date of Preparation: | 10/28/15 |
2. Device Information
| Trade Name | Vera™ |
|---|---|
| Common Name | Software system utilizing optical recording forrehabilitation exercises |
| Classification Name | System, optical position / movement recording |
| Model Number | Version 2 |
| 510(k) Submitter / Holder | Reflexion Health |
| 510(k) Number | K150462 |
| Predicate 510(k) Number | K130847 |
| Device Panel | Physical Medicine |
| Product Code | LXJ |
| Classification Regulation | Unclassified |
3. Description of Device
- A. The main goal for the Vera™ software is to motivate patients to engage in their home physical therapy exercise program. The Reflexion Health team has done this by augmenting the "paper handouts" currently supplied to patients with purpose-built, mobile medical applications. The Vera™ software utilizes three off-the-shelf accessories: a motion sensing camera, a monitor and a computer; to provide physical therapists and physicians with a software system to prescribe customized physical therapy plans for patients. Vera™ software provides medical professionals the tools to record video and track movements in three-dimensional space in order to identify motion and count repetitions during patient participation with a prescribed exercise. Data derived from motion tracking as well as the recorded video can be reviewed by medical professionals to assess exercise movements and adherence to the prescribed exercise; Vera™ is a software tool that helps extend that expertise.
The hazard analysis of the Vera™ software also indicates low risk to the end user. Pursuant to the FDA's Guidance Document for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005), the Vera™ software level of concern is Moderate.
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B. Device Components
The Vera™ software has three separate applications. -
Patient Application. This application prompts and monitors patients in the i. performance of a therapy prescribed by their Clinician, monitors and reports exercise data to the Clinician for analysis, and permits a Patient to communicate with that Clinician.
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ii. Clinician Application. This application allows a Clinician to define and update a patient's personal data, a patient's therapy prescription, to monitor a patient's performance of that therapy, and permits a Clinician to communicate with a patient.
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iii. Server Application. This application provides services needed by the various applications to move the necessary data between themselves accurately and securely. It also permits an IT professional to monitor and maintain the infrastructure needed by the different applications.
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C. Device Accessories
- Motion Sensing Camera: i. The Kinect Sensor from Microsoft uses structured infrared light to determine the position of objects in its field of view in three dimensions including distance, or "depth", from the camera.
- Microsoft Kinect Sensor Driver App v2.0 ..= A software, provided by Microsoft, that tells the computer's operating system exactly how to work with the Microsoft Kinect Sensor.
- iii. Computer (minimum configurations):
- iv. Monitor with touch screen (or standard monitor with keyboard)
| General 510(k) Information | Predicate Device |
|---|---|
| Trade Name | Jintronix Rehabilitation System |
| 510(k) Number | K130847 |
| Device Panel | Physical Medicine |
| Product Code | LXJ |
| 510(k) Submitter | Jintronix, Inc. |
4. Predicate / Substantially Equivalent Device
5. Intended Use
A software system used with the Microsoft Kinect v2 intended to support the physical rehabilitation of adults in the clinic and at home. The system includes rehabilitation exercises for the lower extremity with audio-visual feedback & graphic movement representations for patients as well as remotely accessible patient performance video. Patient assessment, exercise guidance and approval by a medical professional is required prior to use.
The device does not provide patient-specific feedback or assessment of the quality of the movement. The clinician who monitors the exercises provides the assessment.
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6. Comparative Summary of Technological Characteristics
| Characteristics | Predicate, JintronixRehabilitation System,K130847 | Vera™ | SubstantialEquivalenceClaim |
|---|---|---|---|
| Principles ofOperation | The JRS allows a medicalprofessional to assignmovement activities topatients. | Vera™ allows medicalprofessionals to assignmovement activities topatients. | Equivalent |
| JRS tracks upper extremityand trunk movementproviding visual feedback of apatient movement andreports on kinematicparameters like velocity andjoint angular changes duringmovement. | Vera™ tracks rehabilitationmovements providing visualfeedback of a patientmovement and reports onkinematic parameters like jointangular changes duringmovement. | ||
| Energy Used /Delivered | Not applicable as JRS is asoftware product. | Not applicable as Vera™ is asoftware product. | Equivalent |
| Human Factors | No safety concern as no directcontact of JRS / Kinect withpatients. | No safety concern as no directcontact of Vera™ / motionsensing device with patients. | Equivalent |
| JRS prescription and remotemedical professionalmonitoring of patients allowssafe home basedrehabilitation exercises.JRS has been validated foraccuracy / performanceeffectiveness both clinicallyand through software testingwith appropriate changemanagement and designcontrols. The JRS also | Vera™ prescription and remotemedical professionalmonitoring of patients allowssafe home based rehabilitationexercises.Vera™ has been validated foraccuracy / performanceeffectiveness both clinicallyand through software testingwith appropriate changemanagement and designcontrols. The Vera™ alsoincorporates correction of | ||
| incorporates correction oferror in Kinect motion sensingto achieve optimal Kinectaccuracy. | error in Kinect motion sensingto achieve optimal Kinectaccuracy. | ||
| Usability & Effectivenessconsideration: JRS waspredominantly recommendedby medical professionals forthe physical rehabilitation oftheir patients. | Usability & Effectivenessconsideration: Vera™ waspredominantly recommendedby medical professionals forthe physical rehabilitation oftheir patients. | ||
| Design | JRS design requires opticalmotion sensing technologyand computer operatingsystem with Windows foroperation. | Vera™ design requires opticalmotion sensing technologyand computer operatingsystem for operation. | Equivalent |
| Materials /Technologyused | JRS comprises of JRS Wave(client application software) &JRS Portal (web portal). TheJRS is to be used with theKinect for optical motioncapture and a MicrosoftWindows computerworkstation. | Vera™ System consists of aPatient Application, ClinicianApplication and ServerApplication. The Vera™ is to beused with a motion sensingdevice for optical motioncapture and a computerworkstation. | Equivalent |
| Biocompatibility | Not applicable as JRS is asoftware product. | Not applicable as Vera™ is asoftware product. | Equivalent |
| Compatibilitywith theenvironmentand otherdevices /SystemCompatibility | The compatibility of JRSsoftware with Kinecthardware and computeroperating systemrequirements have beenvalidated. Suitable changemanagement and designcontrols have beenimplemented. | The compatibility of Vera™software with Kinect hardwareand computer operatingsystem requirements have beenvalidated. Suitablechange management anddesign controls have beenimplemented. | Equivalent |
| Characteristics | Predicate, Jintronix Rehabilitation System, K130847 | Vera™K150462 | Substantial Equivalence Claim |
| Electrical Safety | Not applicable as JRS is a software product. | Not applicable as Vera™ is a software product. | Equivalent |
| Mechanical Safety | Not applicable as JRS is a software product. | Not applicable as Vera™ is a software product. | Equivalent |
| Thermal Safety | Not applicable as JRS is a software product. | Not applicable as Vera™ is a software product. | Equivalent |
| Chemical Safety | Not applicable as JRS is a software product. | Not applicable as Vera™ is a software product. | Equivalent |
| Radiation Safety | Not applicable as JRS is a software product. | Not applicable as Vera™ is a software product. | Equivalent |
| Sterility | JRS is a non-sterile product. | Vera™ is a non-sterile product. | Equivalent |
Table 1: Technological Characteristics Comparison
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Table 2: Safety Comparison
Substantial Equivalence Conclusion:
As described under Tables 1-2 above, the Vera™ system is substantially equivalent to the predicate device in terms of intended use, principles of operation, human factors, design, materials, technology used, compatibility with the environment and / other devices, and safety. There are no differences between the Vera™ software and the predicate device and Vera™ is at least as safe and effective as the predicate.
7. Clinical Performance Data
A clinical study was performed to analyze the clinical relevance of exercises delivered by the Vera System. The study verified that physical movements delivered by Vera, executed by an individual interacting with the system, and captured by video are recognized by Clinicians to be physical rehabilitation exercises. Clinicians reviewed a series of video recordings of healthy volunteers performing rehabilitation movements to verify that the movement seen in the video is recognized as physical therapy exercise and determine if they would recommend the movement to their patients. Potential risks for their patients posed by the movements seen in the video were identified by the Clinicians.
Safety & Effectiveness Summary
The clinical study results were predominantly 100% exceeding the 95% acceptance criterion for all Vera activity movements demonstrating that the Vera movements are clinician recognized rehabilitation movements and validating the accuracy of the Vera in data processing.
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Of the 230 exercises observed (10 PTs x 23 Exercises/PT), 223 (97.0%) were correctly described by the PTs.
96.7% of therapists agreed that the exercises viewed were typical of those prescribed for rehabilitation purposes and 96.7% would recommend the exercises demonstrated to appropriate patients. The data presented in this report confirm that when users perform exercises delivered by Vera, these exercises are considered rehabilitation exercises by physical therapists.
| Category | Potential Risks | Recommendations for RiskMitigation |
|---|---|---|
| 1 | The exercise was determined to beunsafe if the user was using unsafeaccessories such as using a chair withwheels which could compromisebalance and increase risk of falling orpoor form. | Recommend that cliniciansadvise patients on theappropriate use of ancillaryequipment to promote properbalance, achieve good form andavoid risk of falling prior to andduring the use of Vera. |
| 2 | The exercise was deemed unsafe to beprescribed by a physical therapist forthe patient due to patient's functionalability, level of impairment, or diagnosis. | Recommend that cliniciansthoroughly evaluate the patient'sfunctional status and assign arehabilitation program mostsuitable to the patients functionalability, level of impairment, anddiagnosis |
| 3 | The exercise was deemed unsafe to beprescribed by a physical therapist forthe patient due to patient's healthhistory. | Prior to enrollment of a patientinto a rehabilitation exerciseprogram and the use of Vera werecommend that cliniciansconduct and/or review a patienthealth history. |
The risks that were identified by the Clinicians were classified into three categories:
The risks identified by the clinicians are considered "universal risks" that physical therapists must consider when prescribing rehabilitation exercises to patients. Such risks are inherent in prescribing any rehabilitation exercises and it is the clinician's responsibility to evaluate a patient and prescribe exercises appropriate for the patient's health status and ability.
8. Non Clinical & Clinical Conclusions
The clinical study demonstrates that the Vera movements are medically recognized rehabilitation movements and is as safe, as effective, and performs as well or as better than the Predicate, K130847.
§ 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.