Jintronix is a software system used with the Microsoft Kinect v2 intended to be used to support the physical rehabilitation of adults in the clinic/ at home. The system includes rehabilitation exercises for the upper extremity, trunk, and lower extremity 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.

Device Description

Jintronix Version 2.0.140905, a software system comprising of a client application and a web application is to be used with the Microsoft Kinect version 2 to support the physical rehabilitation of adults in the clinic/ at home.

Through the client application, the patient engages in their rehabilitation exercises. Using the Microsoft Kinect for Windows, which tracks the patient's upper extremity, trunk, and lower body joint positions as they move, the software provides a graphic representation of the patient's movements, as well as activities that include visual and audio feedback to support the patient in performing therapeutic exercise.

As the patient engages in exercises, the system records performance metrics, such as the speed and precision of their movements. These metrics are then sent to a remote web application.

Clinicians, through a "clinician interface" of the Client application, securely access the remote web application to remotely monitor the progress of their patients, and modify the exercise program through program customizations (for example, difficulty level) based on patients' needs.

Patient assessment, exercise guidance and approval by the medical professional is required prior to use. There is no direct contact with the patient since the device is a software product. No energy is delivered to the subject.

AI/ML Overview

The provided text describes the Jintronix Version 2.0 device and its 510(k) submission. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Data Processing Accuracy	Jintronix data processing accuracy verified by software testing. Clinician feedback.
System Compatibility	System compatibility of Jintronix software, Microsoft Kinect v2 hardware, and the recommended computer operating system in Jintronix labeling assured by software testing.
Kinect Performance Accuracy / Effectiveness	Jintronix surpasses predicate JRS in performance. Jintronix uses the Kinect v2 (for optical motion capture) which is more precise over a greater tracking range than Kinect v1 used with predicate JRS. Jintronix can be consistently reproduced within an error tolerance that is comparable to intra-rater precision error of goniometry. Shoulder range of motion measurements can only be used to describe a patient's relative change in joint angle, not absolute joint angle. Shoulder ROM measurements have not been validated in standardized postures associated with goniometric measurements. Bench study recommendations for optimal performance have been incorporated or accounted for.
Kinect Electrical Safety	Kinect is deemed electrically safe. It conforms to IEC 60825-1:2007:03 for a Class 1 laser product and 21 CFR 1040.10 & 1040.11 (except for deviations per Laser Notice No. 50).
Software Life Cycle Processes	Jintronix conforms partially to AAMI / ANSI / IEC 62304:2006.
AGILE Practices Guidance	Jintronix conforms partially to AAMI TIR45:2012.
Premarket Submissions for Software Guidance	Jintronix conforms partially to the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 2005).
General Principles of Software Validation	Jintronix conforms partially to the "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" (January 2002).
FDA Quality System Regulation (QSR) 21 CFR 820	Jintronix Inc.'s quality system is compliant with FDA's Quality System Regulation 21 CFR 820, with appropriate design and change controls implemented.
Labeling Controls	Jintronix is a prescription use device with various labeling precaution statements, including requiring an in-person patient-exercise suitability assessment prior to prescription.

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

The document mentions a "Bench Study" for Kinect v2 Performance Accuracy/Effectiveness, where "Kinect's accuracy was determined in terms of kinematics over a range of distances between the Kinect and the user." It also states the Kinect v2 was compared to the Optotrak, Kinect v1, and goniometry.

Sample Size for Test Set: The document does not specify the sample size of "users" or "movements" or "distances" evaluated in the bench study for the test set.
Data Provenance: The study was "commissioned an independent study to determine the performance accuracy of Microsoft Kinect v2". No country of origin is explicitly stated for the data itself, but the company Jintronix Inc. has offices in Seattle, WA, and Montreal, Canada, while AxSource Consulting Inc. is in Milton, Ontario, Canada. The study is described as a "Bench Study," suggesting it was conducted in a controlled environment. The provenance is internal to the development and testing process, likely involving controlled experimental setups. It is a prospective study in the sense of specifically testing the device's performance.

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

The document states that the Kinect v2 performance was compared to:

Optotrak: Described as "a gold standard in motion sensing technology with a reported precision of less than 0.5mm." This serves as a high-precision ground truth reference.
Goniometry: Described as "the clinical standard for range of motion measurements."

The document does not specify the number of human experts used to establish the ground truth for the test set. It mentions "intra-rater precision error of goniometry" but doesn't detail how many raters or their qualifications were involved in the ground truth establishment for the bench study. The focus appears to be on the objective comparison of devices (Kinect v2 vs. Optotrak, goniometry) rather than expert consensus on patient data.

4. Adjudication Method for the Test Set

Not applicable/provided. The bench study described compares the device's measurements against established technical (Optotrak) and clinical (goniometry) standards. There is no mention of human adjudication of results in the traditional sense of medical image or clinical data interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not conducted or reported in this document. The study described is a bench study comparing the device's technical performance against other measurement tools.

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

Yes, the "Bench Study - Kinect v2 Performance Accuracy / Effectiveness" is a standalone algorithm-only performance study. It assessed the Kinect v2's ability to "consistently reproduce" range of motion measurements and its precision compared to Optotrak, Kinect v1, and goniometry. This evaluates the technical capability of the motion capture system inherent to Jintronix without a human clinician actively interpreting or adjudicating the AI's output in a clinical context. The "Data Processing Accuracy" verified by "software testing" also implies standalone evaluation of the software components.

7. The Type of Ground Truth Used

The ground truth used in the bench study was:

Reference Device Measurement: Optotrak, "a gold standard in motion sensing technology with a reported precision of less than 0.5mm."
Clinical Standard Measurement: Goniometry, "the clinical standard for range of motion measurements."

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for any training set. As primarily a software and hardware system that tracks movement, Jintronix's core functionality likely relies on the pre-trained models within the Microsoft Kinect v2 for skeletal tracking. The Jintronix software itself integrates this tracking and provides exercises and metrics. The validation described is of the system's integration and accuracy compared to other measurement tools, not necessarily an AI model trained on a specific dataset by Jintronix.

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

The document does not provide information on how ground truth was established for any training set. Given that Jintronix utilizes the Microsoft Kinect v2, the underlying skeletal tracking and pose estimation within the Kinect v2 would have been trained by Microsoft, and the methods for establishing ground truth for that training are not detailed here. The Jintronix submission focuses on the performance and validation of its application built on top of the Kinect v2.

Summary

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

April 22, 2015

Jintronix Inc. c/o Navneet Sekhon AxSource Consulting Inc. 336 Bronte Street South, Suite 224-225 Milton, Ontario L9T 7W6

Re: K143034

Trade/Device Name: Jintronix Version 2.0 Regulatory Class: Unclassified Product Code: LXJ Dated: March 19, 2015 Received: March 20, 2015

Dear Ms. 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. Isting 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/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 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,

Felipe Aquel -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

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Indications for Use

510(k) Number (if known) K143034

Device Name Jintronix Version 2.0

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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JINTRONIX TRADITIONAL 510(k)

7. 510(k) Summary

7.1 Owner Information

Name:	Jintronix Inc.
Device common name:	System, optical position/movement recording
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:	March 13, 2015

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
Contact Person:	Ms. Navneet Sekhon, President
Email:	nav.sekhon@axsource.ca

7.3 Device Information

Trade Name	Jintronix
Common Name	System, optical position/movement recording
Classification name	System, optical position/movement recording
Model Number	Version 2.0.140905
510(k) Submitter / Holder	Jintronix Inc.
Device Panel	Physical Medicine
Product Code	LXJ
Classification Regulation	Unclassified

7.4 Predicate(s) / Substantially Equivalent Device(s)

Generalinformation	510(k)	Predicate Device(s)[510(k) summaries attached – Appendices 6 & 7]
Trade Name	Jintronix	Peak Motus MotionMeasurement System
Model Number	Version 1.0	Unknown

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Image /page/4/Picture/0 description: The image contains the logo for Jintronix. The logo features a stylized square shape with interconnected blue and green squares inside, resembling a network or circuit board. Below the graphic is the company name, "JINTRONIX," in a bold, sans-serif font, with "JINTRON" in blue and "IX" in green, mirroring the colors used in the square graphic above.

Generalinformation	510(k)	Predicate Device(s)[510(k) summaries attached – Appendices 6 & 7]
510(k) Submitter / Holder	Jintronix Inc.	PeakTechnologies Inc.
510(k) Number	K130847	K030714
Device Panel	Physical Medicine	Physical Medicine
Product Code	LXJ	LXJ

7.5 Device Description

As the patient engages in exercises, the system records performance metrics, such as the speed and precision of their movements. These metrics are then sent to a remote web application.

7.6 Indications for Use

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Image /page/5/Picture/0 description: The image contains a logo for a company called Jintronix. The logo features a stylized square shape with rounded corners, filled with a pattern of blue and green squares. Below the square is the company name, "JINTRONIX," written in a bold, sans-serif font, with the "JIN" in blue and the "TRONIX" in green.

	Predicate Device(s)[510(k) summaries attached]		Jintronix(v2.0.140905)	Jintronix andPredicate(s)Discussion
	JintronixRehabilitationSystem (JRS)	Peak Motus
Indicationsfor Use	A software systemused with theMicrosoft Kinectintended to beused to supportthe physicalrehabilitation ofadults in the clinic/at home. Thesystem includesrehabilitationexercises for theupper extremityand trunk withaudio-visualfeedback &graphic movementrepresentations forpatients as well asremotelyaccessible patientperformancemetrics for themedicalprofessional.Patientassessment,exercise guidanceand approval bythe medicalprofessional isrequired prior touse. 1	Computer andvideo system usedto quantify andgraphically displayhuman movementpatternsand techniques foruses such asassessment andtraining of limb orbody motion in gaitanalysis, prostheticdesign, pre/postrehabilitationevaluation, physicaltherapy, and thelike.2	A softwaresystem usedwith theMicrosoft Kinectversion 2intended to beused to supportthe physicalrehabilitation ofadults in theclinic/ at home.The systemincludesrehabilitationexercises for theupper extremity,trunk, and lowerextremity, withaudio-visualfeedback &graphicmovementrepresentationsfor patients aswell as remotelyaccessiblepatientperformancemetrics for themedicalprofessional.Patientassessment,exerciseguidance andapproval by themedicalprofessional isrequired prior touse.	Jintronix sharesthe sameindications foruse as thepredicates. Alldevices areintended forphysicalrehabilitation. Alldevices includegraphicmovementrepresentationsand performancemetrics forassessment.Like the JRS,Jintronix is forclinic/at homephysicalrehabilitation ofthe upperextremity andtrunk.Like predicatePeak Motus,Jintronix isindicated forlimbs and fullbody.No differencebetweenJintronix andpredicates.

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Image /page/6/Picture/0 description: The image contains a logo for Jintronix. The logo features a blue and green square with a network of blue squares inside. Below the square is the word "JINTRONIX" in green, with the letters in a bold, sans-serif font. The logo appears to be for a technology or software company.

1 FDA 510(k) Database. Jintronix Rehabilitation System. 510(k) Summary (attached). Retrieved August 30, 2014, from http://www.accessdata.fda.gov/cdrh_docs/pdf13/[K130847](https://510k.innolitics.com/search/K130847).pdf 2 FDA 510(k) Database. Peak Motus Motion Measurement System. 510(k) Summary (attached). Retrieved September 23, 2014, from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?lD=11114

7.7 Comparison of Technological Characteristics with Predicate Device(s)

Principles of operation and fundamental design and technology considerations are shared by Jintronix and its predicates.

Specifically, Jintronix and its predicate(s)

Are software / hardware systems or computer systems using optical capture motion technology 1.
1. Track movement and provide visual feedback or graphic movement representations
1. Report on kinematic parameters or provide performance metrics for assessment
1. Are non-invasive devices and so do not deliver energy to patients
1. Do not pose any issues in terms of electrical, chemical, thermal or radiation safety
1. Are non-sterile devices

Jintronix is validated for system compatibility and performance.

The following technological differences exist between Jintronix and its predicates.

1. Jintronix improves usability with its new design features which include enhanced software user interfaces and a simple range of motion assessment feature desired by clinicians.
1. Jintronix surpasses predicate JRS in performance. Jintronix uses the Kinect v2 for optical motion capture. The Kinect v2 is more precise over a greater tracking range than Kinect v1 used with predicate JRS.

7.8 Performance Data

7.8.1 Performance Data Summary / Conclusions

Jintronix system performance is validated as suitable for its indications for use surpassing the performance of predicate JRS. With improved performance accuracy, Jintronix has a better safety and effectiveness profile when compared to predicate JRS.

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Image /page/7/Picture/0 description: The image contains a logo with the word "JINTRONIX" in green, with the top half of the logo containing a blue and green square design. The blue squares are connected to each other, and the green squares are on the top right of the design. The logo is surrounded by a green border.

TRADITIONAL 510(k)

JintronixSystem	SupportingPerformance Data	Performance Conclusions & SE Comparisonto Predicate(s)
Data ProcessingAccuracy	1. System Validation	1. Jintronix data processing accuracy verifiedby software testing.2. Clinician feedback.
SystemCompatibility	System Validation(software testing)	System compatibility of Jintronix software,Microsoft Kinect v2 hardware and therecommended computer operating system inJintronix labeling assured by software testing.
KinectPerformanceAccuracy /Effectiveness	Bench Study	Jintronix surpasses predicate JRS inperformance. Jintronix uses the Kinect v2 (foroptical motion capture) which is more preciseover a greater tracking range than Kinect v1used with predicate JRS.Jintronix can be consistently reproduced withinan error tolerance that is comparable to intra-rater precision error1 of goniometry. Shoulderrange of motion measurements can only be usedto describe a patient's relative change in jointangle, not absolute joint angle. Shoulder range ofmotion measurements have not been validatedin standardized postures associated withgoniometric measurements.Bench study recommendations for optimalperformance have been incorporated oraccounted for.
Kinect ElectricalSafety	Refer to FDArecognized standardand test reports forClass I laser (section7.8.3 below)	Kinect deemed electrically safe.

7.8.2 System Validation for System Compatibility & Performance Accuracy

Jintronix system accuracy in data processing was validated by software testing. Jintronix software is of "moderate" level of concern. All potential device hazards have been mitigated through appropriate controls. Jintronix software has been validated with Windows Defender, anti-virus software.

Jintronix conforms partially to the following FDA recognized standards and associated FDA guidance documents.

1. Medical device software Software life cycle processes AAMI / ANSI / IEC 62304:2006
  1 Defined as the degree of agreement among repeated administrations of a diagnostic test performed by a single rater

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Image /page/8/Picture/0 description: The image contains the logo for Jintronix. The logo features a stylized graphic of interconnected squares in shades of blue and green, enclosed within a rounded rectangular border, also in blue and green. Below the graphic, the word "JINTRONIX" is written in a bold, sans-serif font, with "JINTRON" in blue and "IX" in green.

1. Guidance on the use of AGILE practices in the development of medical device software AAMI TIR45:2012
1. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 2005
1. General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 2002

7.8.3 Electrical Safety

Jintronix is software for use with Microsoft Kinect v2 hardware. The Microsoft Kinect v2 used with Jintronix software is electrically safe. The Kinect for Windows v2 hardware conforms to the International Standard IEC 60825-1:2007:03 for a Class 1 laser product and with 21 CFR 1040.10 & 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007.

7.8.4 Bench Study - Kinect v2 Performance Accuracy / Effectiveness

Jintronix Inc. commissioned an independent study to determine the performance accuracy of Microsoft Kinect v2, the optical motion capture technology for use with Jintronix. 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 v2 was compared to the Optotrak, a gold standard in motion sensing technology with a reported precision of less than 0.5mm. Kinect v2 performance was compared to that of Kinect v1 and goniometry, the clinical standard for range of motion measurements.

The bench study found that Jintronix range of motion (ROM) assessments using the Kinect v2 can be consistently reproduced within an error tolerance that is comparable to intra-rater precision error2 of goniometry.

7.9 Other Information

7.9.1 Jintronix Compliance to FDA Quality System Regulation (QSR) 21 CFR 820

Jintronix has been implemented with appropriate design and change controls per Jintronix Inc.'s quality system which is compliant with FDA's Quality System Regulation 21 CFR 820. Standard Operating Procedures relevant to this 510(k) have been referenced herein.

7.9.2 Jintronix Labeling Controls

Jintronix is a prescription use device and various labeling precaution statements further serve as potential device hazard mitigation controls. This includes requiring an in person patient-exercise suitability assessment prior to Jintronix prescription.

2 Defined as the degree of agreement among repeated administrations of a diagnostic test performed by a single rater

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7.10 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. .

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.