The Recovr Rehabilitation System is software for use with the Microsoft Kinect motion tracking system that is indicated to support physical rehabilitation of adults in the clinic and at home via performance of therapist-assigned reach exercises for the upper extremities. Patient assessment, exercise guidance, and approval by the medical professional are required prior to use.

Device Description

The Recovr Rehabilitation System (RRS) is a software system that presents games to facilitate the completion of therapist designed and prescribed upper extremity repetitive reaching exercises and that collects data for the therapist on the user's game play. The system was designed in collaboration with an experienced neurorehabilitation occupational therapist and rehabilitation research team. The RRS is intended for use in the clinic or at home. Patient assessment, exercise guidance, and approval by the medical professional are required prior to use.

The system consists of software, a computer, a primary display monitor, a secondary monitor, and a Microsoft Kinect motion-tracking sensor. Users sit on a bench or stand 6-8 feet away from the primary display monitor. The Kinect sensor is placed along the top or bottom edge of the primary display monitor, and the therapist controls the system from a secondary monitor, mouse, and keyboard off to the side of the primary display monitor. The games are based on a traditional carnival shooting gallery, with targets that pop–up to present reaching tasks. The virtual reality environment incorporates video game principles to engage and motivate users to perform the amount of rehabilitation assigned by the rehabilitation therapist. The system collects data on participant movement and actions throughout each session that allows therapists to track participant performance and improvement across therapy sessions.

The device is not supplied sterile or intended to be sterilized by the operator prior to use, and is not intended for single use.

AI/ML Overview

The Recovr Rehabilitation System (RRS) is a software system intended to support physical rehabilitation for adults, specifically for upper extremity reach exercises, using the Microsoft Kinect motion tracking system.

Acceptance Criteria and Device Performance:

The document explicitly states that "No mandatory performance standards have been established for this device (Section 514 of the Act)." However, it does refer to "Software testing was conducted to verify performance in accordance with FDA's May 2005 guidance document entitled, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.'"

The device performance is generally described in relation to its intended use and comparison to the predicate device, the Jintronix Rehabilitation System (K130847).

Acceptance Criteria (Implied)	Reported Device Performance
Facilitate therapist designed and prescribed upper extremity repetitive reaching exercises.	"The Recovr Rehabilitation System (RRS) is a software system that presents games to facilitate the completion of therapist designed and prescribed upper extremity repetitive reaching exercises..."
Collect data for the therapist on the user's game play.	"...and that collects data for the therapist on the user's game play." and "The system collects data on participant movement and actions throughout each session that allows therapists to track participant performance and improvement across therapy sessions." (This aligns with the predicate device's capability to report on kinematic parameters).
Provide audiovisual feedback and graphic representations of user movement.	"Both platforms... provide audiovisual feedback and graphic representations of the user movement, as well as reporting to the clinician on kinematic parameters like velocity and joint angular changes during movement." (This is stated in comparison to the predicate, implying the subject device also does this).
No risk of harm to the user or operator in case of device failure or latent flaw (due to "minor" level of concern for software).	"The software for this device was considered as a 'minor' level of concern, as there is no risk of harm to the user or operator in the case of device failure or latent flaw." This is a categorization of risk rather than a direct performance metric, but it implies the software's performance contributes to this safety profile. Also, "The devices are also identical in safety, as they are software platforms for use with the Microsoft Kinect motion tracking system."
Substantial equivalence to the predicate device (Jintronix Rehabilitation System K130847) in terms of intended use, performance, and technology.	"The RRS and the predicate Jintronix Rehabilitation System (JRS) are substantially equivalent in terms of intended use and performance and technology." Minor difference noted: "The Indications for Use statement for RRS is not identical to the predicate device in that the Indications for Use for the subject device do not include 'remotely accessible patient performance metrics for the medical professional' at this time." However, the document concludes this difference "does not affect the intended use... nor do they affect the safety and effectiveness of the device relative to the predicate when used as labeled." and "Software verification and validation demonstrate that the subject device should perform as intended in the specified use conditions."

Study Details:

The document describes the regulatory submission for premarket notification (510(k)) and a determination of substantial equivalence, rather than a clinical study proving specific performance metrics against acceptance criteria.

Sample size used for the test set and the data provenance:
- No specific test set or sample size for performance evaluation by the FDA is mentioned in this document. The FDA's determination is based on the provided information, which includes software verification and validation, but not a separate clinical test set of patients. No data provenance (country of origin, retrospective/prospective) is specified for performance testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The RRS was "designed in collaboration with an experienced neurorehabilitation occupational therapist and rehabilitation research team," but this refers to the development process, not the establishment of ground truth for a test set for FDA submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no specific test set requiring ground truth adjudication is described for the purpose of this FDA submission.
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 MRMC comparative effectiveness study is mentioned. The device is a rehabilitation system, not a diagnostic imaging device typically associated with MRMC studies or "human readers improving with AI assistance." The software's role is to facilitate exercises and collect data, not to assist human interpretation of medical images or data in an "AI-assisted reading" context.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that "software verification and validation" was conducted. However, the system is designed to be "software for use with the Microsoft Kinect motion tracking system" and requires "Patient assessment, exercise guidance, and approval by the medical professional are required prior to use." This means the device is inherently intended for use with a human-in-the-loop (the patient and the medical professional). The document does not describe performance of the algorithm stand-alone without this human interaction context.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not explicitly stated for performance testing. The "ground truth" for the device's functionality likely stems from its ability to accurately track motion and present exercises as designed, as verified during software development and validation activities.
The sample size for the training set:
- Not applicable. The document describes a software system that facilitates physical rehabilitation exercises, not a machine learning or AI model trained on a dataset. Therefore, there is no "training set" in the conventional sense of AI/ML development.
How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set for an AI/ML model.

Summary

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

September 18, 2015

Recovr, Inc % Kathryn Cole Principle Translational Science Solutions LLC 92 Hasell Street, Suite 401 Charleston, South Carolina 29401

Re: K151446

Trade/Device Name: Recovr Rehabilitation System Regulatory Class: Unclassified Product Code: LXJ Dated: August 4, 2015 Received: August 10, 2015

Dear Kathryn Cole:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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

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

Sincerely yours,

Carlos L. Pena -5D/Δ

Carlos L. 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) K151446

Device Name Recovr Rehabilitation System

Indications for Use (Describe)

The Recove Rehabilitation System is software for use with the Microsoft Kinect motion tracking system that is indicated to support physical rehabilitation of adults in the clinic and at home via performance of therapist-assigned reach exercises for the upper extremities. Patient assessment, exercise guidance, and approval by the medical professional are 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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5.0 510(K) SUMMARY

Submission Date:	September 17, 2015
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Submitter Information:

Submitted By:	Recovr, Inc.Post Office Box 772Clemson, SC 29633
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Contact Person: Austen Hayes, MS Chief Executive Officer Tel: (843) 425-1606 Email: austen@recovrinc.com

Device Information:

Trade Name:	Recovr Rehabilitation System
Common Name:	Software system utilizing optical position recording forrehabilitation exercises
Classification Name:	System, Optical Position/Movement Recording (ProductCode LXJ)
Regulatory Class:	Unclassified
Predicate Device:	Jintronix Rehabilitation System (K130847)Jintronix, Inc.Unclassified (Product Code LXJ)
Device Description:	The Recovr Rehabilitation System (RRS) is a softwaresystem that presents games to facilitate the completionof therapist designed and prescribed upper extremityrepetitive reaching exercises and that collects data forthe therapist on the user's game play. The system wasdesigned in collaboration with an experiencedneurorehabilitation occupational therapist andrehabilitation research team. The RRS is intended foruse in the clinic or at home. Patient assessment,exercise guidance, and approval by the medicalprofessional are required prior to use.The system consists of software, a computer, a primarydisplay monitor, a secondary monitor, and a MicrosoftKinect motion-tracking sensor. Users sit on a bench orstand 6-8 feet away from the primary display monitor.The Kinect sensor is placed along the top or bottomedge of the primary display monitor, and the therapistcontrols the system from a secondary monitor, mouse,and keyboard off to the side of the primary displaymonitor. The games are based on a traditional carnival

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shooting gallery, with targets that pop–up to present reaching tasks. The virtual reality environment incorporates video game principles to engage and motivate users to perform the amount of rehabilitation assigned by the rehabilitation therapist. The system collects data on participant movement and actions throughout each session that allows therapists to track participant performance and improvement across therapy sessions.

The device is not supplied sterile or intended to be sterilized by the operator prior to use, and is not intended for single use.

Indications for Use: The Recovr Rehabilitation System is software for use with the Microsoft Kinect motion tracking system that is indicated to support physical rehabilitation of adults in the clinic and at home via performance of therapistassigned reach exercises for the upper extremities. Patient assessment, exercise quidance, and approval by the medical professional are required prior to use.

The Indications for Use statement for RRS is not identical to the predicate device in that the Indications for Use for the subject device do not include "remotely accessible patient performance metrics for the medical professional" at this time. That minor difference does not affect the intended use of the subject device as a software system utilizing optical position recording for physical rehabilitation exercises nor do they affect the safety and effectiveness of the device relative to the predicate when used as labeled.

Comparison to The RRS and the predicate Jintronix Rehabilitation Predicate Device: System (JRS) are substantially equivalent in terms of intended use and performance and technology. Both platforms are software systems utilizing optical position recording for physical rehabilitation exercises that use the Microsoft Kinect motion tracking system. Both systems require patient assessment and exercise quidance from a clinical or medical professional prior to any exercise prescription. Both devices track the movements assigned by the clinician, providing audiovisual feedback and graphic representations of the user movement, as well as reporting to the clinician on kinematic parameters like velocity and joint angular changes during movement. The devices are also identical in safety, as they are software platforms for use with the Microsoft Kinect motion tracking system. At this point in time, the subject device does not include remotely accessibly patient performance metrics for the

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medical professional, but that does not affect the safety or effectiveness of the device compared to the predicate.

Performance Testing: No mandatory performance standards have been established for this device (Section 514 of the Act). Software testing was conducted to verify performance in accordance with FDA's May 2005 quidance document entitled, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "minor" level of concern, as there is no risk of harm to the user or operator in the case of device failure or latent flaw.

No biocompatibility, electrical safety and electromagnetic compatibility, animal, or clinical testing was deemed necessary to support the current finding of substantial equivalence to the predicate Jintronix device.

Conclusion: The RRS falls within the generic type of device regulated by the LXJ Product Code (System, Optical Position/Movement Recording). Differences in the design and presentation of the RRS from the predicate device do not affect the safety, effectiveness, or performance of the subject device for its intended use. Software verification and validation demonstrate that the subject device should perform as intended in the specified use conditions. Therefore, the RRS is substantially equivalent to the Jintronix Rehabilitation System.

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.