(339 days)
A software system used with the Microsoft Kinect intended to support the physical rehabilitation of adults in the clinic/ at home. The system includes rehabilitation exercises 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 guidance and approval by the medical professional is required prior to use.
The device or software comprises of a client application called JRS Wave and a web application or portal called JRS Portal. The JRS is to be used with the Microsoft Kinect motion sensing technology. JRS Wave includes medically recognized gaming exercises for rehabilitation, audio-visual feedback & graphic movement representations for patients. Using the Microsoft Kinect for Windows to track motion, JRS Wave records performance metrics providing them to qualified medical professionals via JRS Portal. Medical professionals can monitor patient performance, assign or modify rehabilitation exercises in JRS Wave for their patients through the JRS Portal allowing for patients to perform their prescribed rehabilitation program even from the comfort of their home.
Here's a summary of the acceptance criteria and study detailed in the provided document for the Jintronix Rehabilitation System (JRS):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| JRS movements are clinician-recognized rehabilitation movements. | Predominantly 100% of clinicians' responses agreed that JRS activity movements were medically recognized rehabilitation exercises, exceeding the 80% acceptance criterion. |
| Accuracy of JRS in data processing (for rehabilitation movements). | The study results validated the accuracy of the JRS in data processing, also indicated by the predominantly 100% clinician recognition of movements. |
| General Safety (e.g., electrical, mechanical, thermal, chemical, radiation) | The device is a software product; external hardware (Microsoft Kinect) uses 12 watts of energy, delivering no energy to the subject. It is non-invasive and a Class 1 laser (posing no safety issue). No mechanical, thermal, or chemical safety concerns were identified for the JRS system itself. |
| Usability & Effectiveness (Clinician Recommendation of JRS Movements) | 88% of clinicians fully recommended JRS movements. 8.5% recommended depending on patient ability. 3.5% not recommended without clinician intervention. The JRS was predominantly recommended by medical professionals for physical rehabilitation. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 20 healthy adult subjects (men and women of various ages).
- Data Provenance: Prospective, conducted in Canada.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: 4 clinicians.
- Qualifications of Experts: Physical and occupational therapists.
4. Adjudication Method for the Test Set
- Adjudication Method: Each of the 4 clinicians assessed one video (a portion of the overall video recording) and completed 50 online questionnaires (10 activity components per subject x 5 subjects). There is no explicit mention of an adjudication process between the clinicians if their assessments differed. However, the reported results are "predominantly 100%," suggesting a high level of agreement.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study regarding human readers improving with AI vs. without AI assistance was not done. The study focused on validating the JRS movements themselves as rehabilitative and the accuracy of data processing.
6. Standalone Performance
- Yes, a standalone (algorithm only without human-in-the-loop performance) validation was implicitly done as the study aimed to "verify that they [movements recorded by JRS] were rehabilitation movements" and "validating the accuracy of the JRS in data processing." The video recording presented to clinicians excluded the software and hardware, focusing only on the subject's movements as captured by the JRS.
7. Type of Ground Truth Used
- Type of Ground Truth: Expert consensus (clinician assessment). Clinicians were asked to identify the movements seen, potential risks, and if they would recommend the movements to their patients.
8. Sample Size for the Training Set
- The document does not explicitly state a separate "training set" for the JRS algorithm in the context of this clinical study. The system's rehabilitation program was "developed in consultation with clinicians," implying that clinical input guided its initial design and exercise content. The study described functions more as a validation of the pre-existing system.
9. How the Ground Truth for the Training Set Was Established
- As mentioned above, a distinct "training set" with established ground truth for an AI algorithm isn't explicitly described in this context. The JRS rehabilitation program was "developed in consultation with clinicians." This suggests that the "ground truth" for the exercises themselves was established through expert clinical input and recognized medical practices during the system's development.
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K130847
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JINTRONIX REHABILITATION SYSTEM (JRS) TRADITIONAL 510(k)
7. 510(k) Summary
7.1 Owner Information
| Name: | Jintronix Inc. |
|---|---|
| Device common name: | Jintronix Rehabilitation System (JRS) |
| Address: | 999 3rd Avenue, Suite 3400, Seattle, WA 98104 |
| Phone: | 1-514-754-6688 |
| Fax: | None |
| Contact: | Mark Evin |
| Title: | Regulatory Affairs & Quality Assurance Head (RAQA) |
| Email: | mark@jintronix.com |
| Date of Preparation: | Jun 03, 2013 |
7.2 Regulatory Correspondent Information
| Name: | AxSource Consulting Inc. |
|---|---|
| Address: | 336 Bronte Street South, Suite 224-225 Milton, Ontario, L9T 7W6 |
| Office Phone: | 905-854-6059 |
| Cell: | 416-452-0100 |
| Contact Person: | Ms. Navneet Sekhon, President |
| Contact Person: | Rachelle D'Souza, Regulatory Affairs Consultant |
| Email: | nav.sekhon@axsource.ca |
| rachelle@axsource.ca |
7.3 Device Information
| Trade Name | Jintronix Rehabilitation System (JRS) | ||
|---|---|---|---|
| Common Name | software system utilizing optical position recording for rehabilitation | ||
| exercises | |||
| Classification | System, optical position/movement recording | ||
| name | |||
| Model Number | Version 1.0 | ||
| 510(k) Submitter / | Jintronix Inc. | ||
| Holder | |||
| 510(k) Number | K130847 | ||
| Device Panel | Physical Medicine | ||
| Product Code | LXJ | ||
| Classification | None. | ||
| Regulation | Reason: JRS is substantially equivalent to predicates in product code | ||
| LXJ. The product code is 'unclassified' in FDA's product classification | |||
| database with the reason being 'pre-amendment'. Refer to URL: | |||
| http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification. | |||
| cfm?ID=4731 |
The device or software comprises of a client application called JRS Wave and a web application or portal called JRS Portal. The JRS is to be used with the Microsoft Kinect motion sensing technology.
JRS Wave includes medically recognized gaming exercises for rehabilitation, audio-visual feedback & graphic movement representations for patients. Using the Microsoft Kinect for Windows to track motion, JRS Wave records performance metrics providing them to qualified medical
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professionals via JRS Portal. Medical professionals can monitor patient performance, assign or modify rehabilitation exercises in JRS Wave for their patients through the JRS Portal allowing for patients to perform their prescribed rehabilitation program even from the comfort of their home.
| General 510(k)information | Predicate Device(s)[510(k) summaries attached - Appendices 5 & 12] | |
|---|---|---|
| Trade Name | Peak Motus Motion Measurement System | Coda cx1 Motion Analysis System |
| Model Number | unknown | unknown |
| 510(k) Submitter /Holder | Peak Performance TechnologiesInc. | Charnwood Dynamics Limited |
| 510(k) Number | K030714 | K033514 |
| Device Panel | Physical Medicine | Physical Medicine |
| Product Code | LXJ | LXJ |
7.4 Predicate(s) / Substantially Equivalent Device(s)
7.5 Intended Use
A software system used with the Microsoft Kinect intended to support the physical rehabilitation of adults in the clinic/ at home. The system includes rehabilitation exercises 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 guidance and approval by the medical professional is required prior to use.
| Differences in indications statements | Why differences do notaffect safety &effectiveness of Jintronixdevice when used aslabeled | |
|---|---|---|
| JRS | Predicates | |
| Gaming exercises intended toelicit medically recognizedrehabilitation exercises frompatients | Do not provide gamingexercises intended toelicit medicallyrecognized rehabilitationexercises from patients. | All JRS gamingexercises are medicallyrecognized (by clinicians/ medical professionals)to be physicalrehabilitation exercises.This is supported by aclinical study andscientific references(refer to Performance –Clinical section). |
| Safety & Effectivenesswere considered in thedevice risk hazardanalysis & in the |
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| Performance sections ofthe 510(k) package | ||
|---|---|---|
| Provides audio feedback | Do not provide audiofeedback | Does not impact safety /effectiveness of JRS |
| Require patient assessmentand exercise guidance fromclinician / medical professionalprior to any exerciseprescription. Exercisesprescribed include originalJRS medically recognizedexercises recommended andJRS exercises modified /customized by the medicalprofessional. | Do not include suchrequirement | Extra precaution toensure proper movementtechnique for home-useof JRS. This puts theJRS at an equivalentlevel of clinicalsupervision as clinician-directed home basedrehabilitation exercises,which are widelyrecommended byscientific literature. |
7.6 Comparative Summary of Technological Characteristics
The JRS and predicates are software / hardware systems that share in common an intended use / indications for use, target populations, anatomical sites, location of use and technological characteristics like principle of operation, design and technology used. All the devices are intended for the physical rehabilitation of patients with orthopedic and neurological conditions. All the devices track limb and body motion, however, JRS body motion tracking is limited to the upper extremity and trunk. All the devices provide visual feedback, process and report on kinematic parameters measured like velocity and joint angular change during movement. JRS provides additional safety and convenience of use in being a prescription use device that enables home based rehabilitation exercises with remote medical professional control. JRS and predicates make use of optical motion sensing technology and a computer operating system. JRS and the predicates also neither deliver energy to patients nor pose any issues in terms of electrical, chemical, mechanical, thermal, radiation safety or compatibility. JRS is validated for system compatibility and performance. There were no issues for JRS in relation to human factors as safety, accuracy performance / effectiveness and usability were thoroughly considered.
| Predicate Device(s)[510(k) summaries attached] | Jintronix | JRS and | ||
|---|---|---|---|---|
| RehabilitationSystem (JRS) | Predicate(s)Discussion | |||
| Peak MotusMotionMeasurementSystem1 | Coda cx1 MotionAnalysisSystem2 | |||
| Technological Characteristics Comparison | ||||
| Predicate Device(s) | JintronixRehabilitationSystem (JRS) | JRS andPredicate(s)Discussion | ||
| [510(k) summaries attached] | ||||
| Peak MotusMotionMeasurementSystem1 | Coda cx1 MotionAnalysisSystem2 | |||
| Principles ofOperation | This systemtracks andprovides visualfeedback ofpatientmovement whilereporting onkinematicparameters suchas velocity andjoint anglesmeasured duringmovement.1 | Information fromthe Codawebsite revealshumanperformanceunderprofessionalsupervision. Asthere are novisual movementcues providedby the Coda, it ispossible toassume, fromthe location ofuse and lab setup video that theguiding cliniciantells the patientwhat movementactivities toperform.7, 8Movementsperformed aretracked,recorded, andanalyzed by theCoda2. | The JRS systemallows a medicalprofessional toassignmovementactivities topatients. Likethe Peak Motus1and the Coda2, 7,the JRS tracksupper extremityand trunkmovementproviding visualfeedback ofpatientmovement andreports onkinematicparameters likevelocity and jointangular changesduringmovement. | NodifferencebetweenJRS andpredicates. |
| Energy Used /Delivered | Electrical energyused byhardware isvariable due tovarious videoinputtechnologies. Noenergy is | Electrical energyis used by bothCODA units andby the activeinfra-red emittingmarkers.6 Noenergy isdelivered intothe subject asthere is no | Not applicableas JRS is asoftwareproduct. TheKinect for usewith the JRS foroptical motioncapture isowned and | Notapplicable toJRS, asoftwareproduct.Energy usedby externalhardware(Microsoft |
| Predicate Device(s) | Jintronix | JRS and | ||
| [510(k) summaries attached] | RehabilitationSystem (JRS) | Predicate(s)Discussion | ||
| Peak MotusMotionMeasurementSystem¹ | Coda cx1 MotionAnalysisSystem² | |||
| delivered intothe subject. 1 | electricalconnection tothe patient.² | distributed byMicrosoft Inc.and uses only12 watts ofenergy. Noenergy isdelivered intothe subject. | Kinect) hasno negativeimpact tosafety. | |
| Human Factors | No comment onhuman factors in510(k)summary.¹Erroneousmarker / sensorplacement onpatients canpose safetyhazard inparametric dataanalysis. Multi-componentsystem maypose usabilityissues. | No comment onhuman factors in510(k)summary.²Erroneousmarker / sensorplacement onpatients canpose safetyhazard inparametric dataanalysis. Multi-componentsystem maypose usabilityissues. | No safetyconcern as nodirect contact ofJRS / Kinect withpatients.Externalhardware,Microsoft Kinectis a Class I laserposing no safetyissue.JRS prescriptionand remotemedicalprofessionalmonitoring ofpatients allowssafe home basedrehabilitationexercises.JRS has beenvalidated foraccuracy /performanceeffectivenessboth clinically(section 22) andthrough softwaretesting withappropriatechanges. | Safety,accuracy,effectivenessand usabilityhave beenconsideredthoroughlyby Jintronix. |
| Predicate Device(s) | JintronixRehabilitationSystem (JRS) | JRS andPredicate(s)Discussion | ||
| [510(k) summaries attached] | ||||
| Peak MotusMotionMeasurementSystem1 | Coda cx1 MotionAnalysisSystem2 | management anddesign controls(section 18). TheJRS alsoincorporatescorrection oferror in Kinectmotion sensing toachieve optimalKinect accuracy(section 18.4).Usability &Effectivenessconsideration:JRS waspredominantlyrecommended bymedicalprofessionals forthe physicalrehabilitation oftheir patients(section 22.1,table 3). | ||
| Design | The system usesoff-the-shelfvideo cameras,sensors, andcomputers tocollect, quantify,and documenthumanmovement intwo-dimensionalor three-dimensionalspace. Itincludes | The technologyincludescomponents forcapturing three-dimensionalmovements ofpatients,acquiring thedata into a hostPC, analyzingand processingthe data, anddisplaying the | Refer to section18.3. Like thepredicates, JRSdesign alsorequires opticalmotion sensingtechnology andcomputeroperatingsystem withWindows foroperation. | Similardesignconsiderations employedby JRS andpredicates. |
| Predicate Device(s)[510(k) summaries attached] | Jintronix Rehabilitation System (JRS) | JRS and Predicate(s) Discussion | Coda cx1 Motion Analysis System2 | |
| Peak Motus Motion Measurement System1components for processing the kinematic data, and displaying it graphically.1 | Materials / Technology used | The system comprises of various software and hardware components which are used with a Microsoft Windows computer workstation. Refer to 510(k) summary for details.1 | Codamotion software with following hardware:• the 'CODA' unit3: the optical capture component• the active infrared-emitting markers3 mounted on the user's body• marker drivebox3: required in order to power the markers• charger tray3• codamotion hub3: in order to provide power to the CODA unit• RS422 data cable3 | Jintronix Rehabilitation System (JRS) comprises of JRS Wave (client application software) & JRS Portal (web portal). The JRS is to be used with the Kinect for optical motion capture and a Microsoft Windows computer workstation. |
| Biocompatibility | Not Applicable to JRS and predicates. JRS / Kinect has no direct contact with patient. | Materials as indicated. Optical motion sensing technology and computer system common to JRS and predicates. |
The following is a comparison of the technological characteristics between the JRS and those of the predicate devices.
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7-5
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| Predicate Device(s)[510(k) summaries attached] | JintronixRehabilitationSystem (JRS) | JRS andPredicate(s)Discussion | ||
|---|---|---|---|---|
| Peak MotusMotionMeasurementSystem¹ | Coda cx1 MotionAnalysisSystem² | |||
| Compatibility withthe environmentand other devices /SystemCompatibility | The system iscompatible withMicrosoftWindows.¹ | The system iscompatible withany standarddesktop orlaptop machinerunningMicrosoftWindows 98,NT, ME, 2000,XP. A processorspeed of at least500MHz isrecommended.The host PCmust have oneserial portinterface foreach CODA unit;these can beRS-232 or RS-422.⁴ | The compatibilityof JRS softwarewith Kinecthardware andcomputeroperatingsystemrequirementshave beenvalidated.Suitable changemanagementand designcontrols havebeenimplemented(see section 17). | JRS isvalidatedsoftware. |
| Safety | ||||
| Electrical safety | No energy isdelivered intothe subject.¹ | No energy isdelivered intothe subject asthe system isnon-invasivewith no electricalconnection tothe user.² Referto standardsbelow. | Not applicableas JRS is asoftwareproduct. Likeboth predicates,no energy isdelivered intothe subject. Likeboth predicates¹², the JRS isnon-invasive.The Kinect foruse with JRS is | Notapplicable toJRS, asoftwareproduct.Energy usedby externalhardware(MicrosoftKinect) hasno negativeimpact tosafety. |
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| Predicate Device(s)[510(k) summaries attached] | JintronixRehabilitationSystem (JRS) | JRS andPredicate(s)Discussion | ||
|---|---|---|---|---|
| Peak MotusMotionMeasurementSystem1 | Coda cx1 MotionAnalysisSystem2 | |||
| owned anddistributed byMicrosoft Inc.and uses only12 watts ofenergy. | ||||
| Mechanical safety | Per the 510(k)summary, safetyis not an issue.1 | Markers andtheir associateddrive boxes areattached to thesubject beingstudied usingmedical doublesided adhesivetape.5 | Not applicableas JRS issoftware. | No issue ofmechanicalsafety toJRS system. |
| Codamotiondocumentation2,4,5 does not citeissues regardingmechanicalsafety. | ||||
| Thermal safety | Undisclosed in510(k)summary1 butsystemcomponents donot provide forthermal safetyconcern. | Per the 510(k)summary2, thissystem does notproduce sourcesof localized heatso no thermalsafety hazardarises. | Not applicableas JRS issoftware. | No issue ofthermalsafety for theJRS system. |
| Chemical safety | Not applicable.Software andhardwaresystem.1 | Not applicable.Software andhardwaresystem.2 | Not applicable.Software only. | Nodifferences |
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| Predicate Device(s)[510(k) summaries attached] | JintronixRehabilitation | JRS andPredicate(s) | ||
|---|---|---|---|---|
| Peak MotusMotionMeasurementSystem1 | Coda cx1 MotionAnalysisSystem2 | System (JRS) | Discussion | |
| Radiation safety | Passive sensorsare used. Perthe 510(k)summary, safetyis not an issue.1 | LED markersare used4,5. Noionizing radiationgenerated.2 | Microsoft TMKinect used withthe JRS emitsinfra-redradiation butcomplies withClass 1 laserstandard. | No adverseimpact tosafety ofpatientsusing JRS |
| Sterility | JRS and predicates1.2 are non-sterile products. JRS is a softwaresystem that uses Microsoft Kinect and a computer operating system.Both predicates are software and hardware systems. |
References in SE Discussion
1 FDA 510(k) Database. Peak Motion Measurement System. 510(k) Summary (attached), Retrieved May 1, 2013, from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=11114
2 FDA 510(k) Database. Coda cx1 Motion Analysis System. 510(k) Summary (attached). Retrieved May 1, 2013, from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=13571
3 Codamotion website. Hardware Components. Retrieved Mav 16, 2013. from http://www.codamotion.com/product-catalogue/hardware-components.html
4 Codamotion System User Guide .. Retrieved May 19, 2013 .. from http://www.codamotion.com/forum/docs/uploads/Codamotion%20System%20UserGuide-7%20Sept%202011.pdf. 9.
5 Codamotion System User Guide. Retrieved May 19, 2013, fromhttp://www.codamotion.com/forum/docs/uploads/Codamotion%20System%20UserGuide-7%20Sept%202011.pdf. 11.
6 Codamotion website. Technology Overview. Retrieved May 16, 2013, from http://www.codamotion.com/systems/technology-overview.html
7 Codamotion website. Clinical Movement Analysis. Retrieved May 16, 2013, from http://www.codamotion.com/applications/clinical.html
8 Codamotion website. Advantages and Capabilities. Retrieved May 16, 2013, from http://www.codamotion.com/applications/clinical/advantages-and-capabilities.html
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* Notation on the Motus 10 web references (3, 4, 5):
The design of the Peak Motus Motion Measurement System approved by CDRH on May 16, 20031 allowed the use of off-the-shelf cameras technologies and was compatible to run on Microsoft Windows. It is in these areas that the system was changed when acquired by Vicon Inc. Beside a name change to Vicon Motus 10, the system was made adaptable to the latest computer operating systems, Windows 7 and 8 and incorporated camera technologies of Contemplas Templo .
The Motus 10 web references # 4 and # 5 concur with the information in the 510(k) summary approved by CDRH1. Only reference # 3 is solely relied on to indicate target patients with orthopedic and neurologic conditions. As the approved 510(k) summary1 lists physical rehabilitation in the indications for use, it is reasonable to assume that the original Peak Motus Motion Measurement System was used for patients with neurologic and orthopedic conditions. Therefore, the changes to the CDRH approved Peak Motus Motion Measurement System does not impact the SE demonstration.
7.7 Predicate Device(s) Non Clinical Summary for Substantial Equivalence Determination
This section is not applicable as no non clinical study for either predicate was used for substantial equivalence determination.
7.8 Clinical Performance Data
Clinical Trial Design
A clinical study was conducted in Canada to study the movements recorded by the JRS and verify that they were rehabilitation movements. The clinical study involved a video recording of 20 healthy adult subjects, men and women of various ages that were required to perform the customized JRS rehabilitation program developed in consultation with clinicians. The video recording meant for clinician assessment focused on the subject and excluded the software and hardware involved, thereby eliminating potential clinician distraction and bias that may have occurred if the clinician liked the software seen in the video. The video was edited to remove unnecessary time gaps between JRS exercises and split into 4 videos for assessment by 4 clinicians (physical and occupational therapists). All raw and edited video footage were backed up and stored on a secure remote server. The 4 videos were uploaded to the web for clinicians to access through a private
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URL. Each clinician accessed one video and completed 50 online questionnaires (10 activity components per subject x 5 subjects). Each questionnaire asked clinicians
-
- To select the movement(s) seen in the video from a list of all JRS supported rehabilitation movements
-
- Identify any potential risks for their patients posed by the movements seen in the video and
- Whether they would recommend the movement seen in the video to their patients. 3.
Safety & Effectiveness Summary
The clinical study results were predominantly 100% exceeding the 80% acceptance criterion for all JRS activity movements demonstrating that the JRS movements are clinician recognized rehabilitation movements and validating the accuracy of the JRS in data processing. The use of JRS movements in the rehabilitation of the intended patient populations have been supported by scientific literature and clinical guidelines. Please refer to section 22.3 Performance Testing -Clinical.
As part of study, clinicians identified the following potential risks, their corresponding vulnerable patient populations and mitigation options (Table 2). As a result, Jintronix has updated labeling accordingly (section 15 Proposed Labeling).
| PotentialRisk(s) | VulnerablePatientPopulation(s) | % Clinicians'responses [n=200(20 subjects x 10JRS activitycomponents)] | Mitigation option(s) for clinicians |
|---|---|---|---|
| Falls | Balance Deficits | 24.5% | Modify JRS rehabilitation program toreduce movement range |
| Clinician intervention prior to JRSuse | |||
| Clinician advises non use of sittingbalance, standing and pop clapactivities of JRS. | |||
| Shoulder Pain /Impingement | Geriatric | 21% | Clinician intervention prior to JRSuse |
| Back Pain | Patientswithback injuries | 2.5% | |
| Knee Injury | GeriatricPatients withknee injury /surgery | 5% | Modify JRS rehabilitation program toreduce movement range, number ofmovement repetitions |
| Clinician intervention prior to JRSuse | |||
| Clinician advises non use ofstanding activity of JRS |
Table 2: JRS Movements - Potentials Risks, Vulnerable Patient Populations and Mitigation Options
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Feedback from clinicians as to whether they would recommend the JRS movements (demonstrated during the clinical trial) to their patients was reported (Table 3).
Table 3: Clinicians Recommendations of JRS Movements
| % Clinicians responses[n=200, (20 subjects x10 JRS activity components)] | Clinicians recommendations of JRS movements in videos |
|---|---|
| 88% | Fully recommended |
| 8.5% | Recommendation depends on patient ability |
| 3.5% | Not recommended without clinician intervention |
Adverse Effects
No adverse effects were reported as expected by study subjects.
7.9 Non Clinical & Clinical Conclusions
The Canadian clinical study demonstrates that the JRS movements are medically recognized rehabilitation movements. The study results also validate the accuracy of the JRS in data processing. Scientific literature in section 22.3 Performance Testing - Clinical further supports the use of JRS movements in the rehabilitation of the patient populations in the JRS intended use.
7.10 Other Information
Kinect Precision
Jintronix with McGill university researchers won a grant from the National Sciences and Engineering Research Council of Canada to conduct a study to determine the accuracy of the Kinect. Kinect's accuracy was determined in terms of kinematics over a range of distances between the Kinect and the user. In the study, the Kinect was compared to the Optotrak, a gold standard in motion sensing technology with a reported precision of less than 0.5mm.
Jintronix Compliance to FDA Quality System Regulation (QSR) 21 CFR 820
Jintronix has implemented a quality system in accordance with FDA's Quality System Requlation 21 CFR 820. Standard Operating Procedures relevant to this 510(k) have been referenced herein.
7.11 This summary
- . includes only information that is also covered in the body of the 510(k).
- . does not contain any puffery or unsubstantiated labeling claims.
- does not contain any raw data, i.e., contains only summary data. ●
- . does not contain any trade secret or confidential commercial information.
- does not contain any patient identification information. .
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 28, 2014
Jintronix, Inc. c/o Navneet Sekhon AxSource Consulting, Inc. 336 Bronte Street South, Suite 224-225 Milton, Ontario L9T 7W6 CANADA
Re: K130847
Trade/Device Name: Jintronix Rehabilitation System Regulatory Class: Unclassified Product Code: LXJ Dated: January 22, 2014 Received: January 23, 2014
Dear Mr. Sekhon:
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
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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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Carlos L. Pena -S
Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K130847
Device Name Jintronix Rehabilitation System
Indications for Use (Describe)
A software system used with the Microsoft Kined in be used to support the physical rehabilitation of advisio' at home. The system includes rehabilitation exercises for the upper extremity and trunk with audio-visual feedback & graphic movement representations for patients as well accessible patient performance metrics for the medical professional. Patient assessment, exercise guidance and approval by the 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Carlos L. Pena -S
FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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§ 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.