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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.

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.

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

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.

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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

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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