The UINCARE software system used with the Microsoft Kinect is intended to be used to support the physical rehabilitation of adults in the clinic or at home. The system includes rehabilitation exercises for the lower and upper extremities with audio- visual feedback & graphic movement representations for patients as well as remotely accessible patient performance metrics for the medical professional. exercise guidance and approval by the medical professional is required prior to use.

Device Description

The UINCARE HOME software system used with the RGB-D Camera is intended to be used to support the physical rehabilitation of adults in the clinic or at home. The system includes rehabilitation exercises for the lower and upper extremities 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 UINCARE HOME software utilizes three off-the-shelf accessories: a motion sensing camera, a monitor and a computer; to provide physical therapists and physicians with a software system to prescribe customized physical therapy plans for patients.

UINCARE HOME software provides medical professionals the tools to record and track movements in threedimensional space in order to identify motion and count repetitions during patient participation with a prescribed exercise. Data derived from motion tracking as well as the patient performance metrics can be reviewed by medical professionals to assess exercise movements and adherence to the prescribed exercise. The UINCARE HOME is a software tool that helps extend that expertise.

The UINCARE HOME software has three separate applications.

(1) UINCARE Client: Patient Application. This application prompts and monitors patients in the performance of a therapy prescribed by their Clinician, monitors and reports exercise data to the Clinician for analysis, and permits a Patient to communicate with that Clinician.
(2) UINCARE Manager: Clinician Application. This application allows a Clinician to define and update a patient's personal data, a patient's therapy prescription, to monitor a patient's performance of that therapy, and permits a Clinician to communicate with a patient.
(3) UINCARE Server: Cloud-based Server. It provides to communicate between the UINCARE Client and UINCARE Manager by the internet as well as to deliver and store the patient information, exercise program information and the result of exercise performed by the patient.

AI/ML Overview

The provided text is a 510(k) Summary for the UINCARE HOME device. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain the detailed information requested regarding acceptance criteria and a specific study proving the device meets those criteria.

Here's a breakdown of why the requested information cannot be fully provided from the given text:

No specific acceptance criteria are listed with numerical targets. The document mentions "Performance tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the allowable deviation." However, these "design specifications" and "allowable deviation" are not quantified or detailed.
No specific study is described with performance results against acceptance criteria. The "Performance Test Range of Motion Assessment Test" is mentioned, but its methodology, results, and specific metrics are absent.

Therefore, many of the requested fields cannot be filled directly from this document. However, I can extract what is available.

Here's the information that can be gleaned about the performance testing for the UINCARE HOME:

A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the document. The document states that "Performance tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the allowable deviation." However, the specific design specifications, acceptance criteria (e.g., in terms of accuracy, precision, or other performance metrics), and the reported numerical performance data are not included.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided. The document mentions "Performance Test Range of Motion Assessment Test" but does not specify the sample size, type of data (e.g., patient data, simulated data), or its provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided. The nature of the "Range of Motion Assessment Test" suggests a comparison to a known standard or expert assessment, but no details on ground truth establishment or experts are given.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided.
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 study was conducted. The device is a software system for physical rehabilitation, not an AI for image interpretation or diagnosis. It assists patients with exercises and provides performance metrics to medical professionals. The document states: "No clinical studies were considered necessary and performed." Therefore, there is no discussion of human readers improving with or without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The "Performance Test Range of Motion Assessment Test" would likely be a standalone assessment of the software's ability to track motion and assess range of motion. However, no specific performance metrics or results are detailed.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The type of ground truth for the "Range of Motion Assessment Test" is not specified. It can be inferred that it involved comparing the device's measurements to a known or established standard for range of motion, but the exact method (e.g., expert measurement, gold standard sensor) is not described.
The sample size for the training set:
This information is not provided. The document mentions "Software Validation" and that it "was designed and developed according to a software development process and was verified and validated," but it does not detail any training sets, as the device is described as a software system using an off-the-shelf camera, not necessarily a machine learning system that requires a distinct training set in the typical sense.
How the ground truth for the training set was established:
This information is not provided, as details about a training set are absent.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

May 10, 2018

UINCARE Corp. % Geum Hyeon Kim Lead Consultant DT&S Co., Ltd. #1206, Mario Tower, 28, Digital-ro 30-gil Guro-gu, Seoul, 08389 Kr

Re: K172882

Trade/Device Name: UINCARE Home Regulation Number: 21 CFR 890.5360 Regulation Name: Measuring Exercise Equipment Regulatory Class: Class II Product Code: LXJ Dated: April 2, 2018 Received: April 26, 2018

Dear Geum Hyeon Kim:

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vivek J. Pinto -S

for 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) K172882

Device Name UINCARE HOME

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K172882 Page 1/6

510(k) Summary

[As required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(a)]

April.02. 2018

●

2. Submitter's Information [21 CFR 807.92(a)[1]]

Name of Manufacturer: UINCARE Corp.
Address: A-603, 131, Gasan digital 1-ro, Geumcheon-gu, Seoul, ●
- 08506, Republic of Korea
Telephone No.: +82-2-6265-0944
+82-2-6265-0945 ● Fax No.:

3. Submission Correspondent

Name of company: ● DT&S Co., Ltd.
- Address: #1206, Mario Tower, 28, Digital-ro 30-gil, Guro-gu, Seoul,
08389, Republic of Korea
Contact Name: GeumHyeon Kim ●
Contact Title Lead Consultant
E-mail Address gh.kim@dtns.co.kr ●
. Telephone No.: +82-2-357-8401
Fax No.: +82-2-357-8027 ●

3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]

Trade Name	UINCARE HOME
Regulation Number	21 CFR 890.5360
Regulation Name	Measuring exercise equipment
Regulation Class	Class II
Product Code	LXJ
Product Code Name	System, Optical Position/Movement Recording

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K172882 Page 2/6

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate devices within this submission are shown as follow;

Contents	Primary Predicate	Reference Predicate
510(k) Number	K151446	K150462
Device Name	Recovr Rehabilitation System	Vera™
Applicant	Recovr, Inc.	Reflexion Health, Inc.
Regulation Name	Measuring exercise equipment	Measuring exercise equipment
Product Code	LXJ	LXJ
Device Class	Class II	Class II

5. Description of the Device [21 CFR 807.92(a)(4)]

The UINCARE HOME software has three separate applications.

(1) UINCARE Client: Patient Application. This application prompts and monitors patients in the performance of a therapy prescribed by their Clinician, monitors and reports exercise data to the Clinician for analysis, and permits a Patient to communicate with that Clinician.
(2) UINCARE Manager: Clinician Application. This application allows a Clinician to define and update a patient's personal data, a patient's therapy prescription, to monitor a patient's performance of that therapy, and permits a Clinician to communicate with a patient.
(3) UINCARE Server: Cloud-based Server. It provides to communicate between the UINCARE Client and UINCARE Manager by the internet as well as to deliver and store the patient information, exercise program information and the result of exercise performed by the patient.

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K172882 Page 3/6

6. Indications for Use [21 CFR 807.92(a)(5)]

The UINCARE software system used with the RGB-D Camera is intended to be used to support the physical rehabilitation of adults in the clinic or at home. The system includes rehabilitation exercises for the lower and upper extremities 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.

7. Determination of Substantial Equivalence

The UINCARE HOME software system is substantially equivalent to legally marketed predicate devices with respect to indications for use and technology characteristics. The proposed device also has similar designs, operation mode, function and accessories with the predicate devices. The Patient Performance Metrics includes continuous ROM tracking graph of major 25 joints and the captured images of patient at designated point of each session. The performance metrics is accessible for the medical professional through the internet. The contents of performance metrics are mostly the same as the reference predicate device, but the UINCARE HOME does include the picture of patient instead of the video. However this is only an additional information to confirm the patient's exercise status. This does not raise of safety or effectiveness. Therefore, the UINCARE HOME software system is substantially equivalent to the predicate device. The below table presents the comparisons for predicate devices:

	Proposed Device	Primary Predicate	Reference Predicate	SE note
K Number	K172882	K151446	K150462	-
Model	UINCARE HOME	Recovr Rehabilitation System	Vera™	-
Manufacturer	UINCARE Corp.	Recovr, Inc.	Reflexion Health, Inc.	-
Indicationsfor Use	The UINCARE softwaresystem used with theRGB-D Camera isintended to be used tosupport the physicalrehabilitation of adultsin the clinic or at home.The system includesrehabilitation exercisesfor the lower and upperextremities with audio-visual feedback &graphic movementrepresentations forpatients as well as	The RecovrRehabilitation System issoftware for use withthe Microsoft Kinectmotion tracking systemthat is indicated tosupport physicalrehabilitation of adultsin the clinic and at homevia performance oftherapist-assignedreach exercises for theupper extremities.Patient assessment,exercise guidance, and	A software system usedwith the MicrosoftKinect v2 intended tosupport the physicalrehabilitation of adultsin the clinic and athome. The systemincludes rehabilitationexercises for the lowerextremity with audio-visual feedback &graphic movementrepresentations forpatients as well asremotely accessible	Same
	Proposed Device	Primary Predicate	Reference Predicate	SE note
	remotely accessiblepatient performancemetrics for the medicalprofessional. Patientassessment, exerciseguidance and approvalby the medicalprofessional is requiredprior to use.	approval by the medicalprofessional arerequired prior to use.	patient performancevideo. Patientassessment, exerciseguidance and approvalby a medicalprofessional is requiredprior to use.
OperationMode	Analysis ModeRehabilitation exerciseModeRehabilitation Game	Analysis ModeRehabilitation exerciseModeRehabilitation Game	Analysis ModeRehabilitation exerciseModeRehabilitation Game	Same
Energy Used/Delivered	Not applicable asUINCARE HOME is asoftware product	Not applicable as RecovrRehabilitation System isa software product	Not applicable as Vera™is a software product	Same
Design	UINCARE HOME designrequires optical motionsensing technology andcomputer operatingsystem for operation.	Recovr RehabilitationSystem design requiresoptical motion sensingtechnology andcomputer operatingsystem for operation.	Vera™ design requiresoptical motion sensingtechnology andcomputer operatingsystem for operation.	Same
Applicationsoftware	Patient ApplicationClinician ApplicationServer Application	Not Known	Patient ApplicationClinician ApplicationServer Application	Same
Motion-TrackingTechnology	Kinect camera	Kinect camera	Kinect camera	Same
Operatingconditions	Windows	Not Known	Windows	Same
Accessories	1) Monitor2) Computer3) Microsoft KinectSensor camera	1) primary displaymonitor, secondarymonitor2) computer3) Microsoft Kinectmotion-tracking sensor	1) Monitor with touchscreen2) Computer3) Microsoft KinectSensor camera	Same
Characteristics	Proposed DeviceUINCARE HOME	Primary Predicate,Recovr RehabilitationSystem, K151446	Reference Predicate,Vera™, K150462	SE note
ElectricalSafety	Not applicable asUINCARE HOME is asoftware product	Not applicable asRecovr RehabilitationSystem is a softwareproduct	Not applicable asVera™ is a softwareproduct	Same
MechanicalSafety	Not applicable asUINCARE HOME is asoftware product	Not applicable asRecovr RehabilitationSystem is a softwareproduct	Not applicable asVera™ is a softwareproduct	Same
ThermalSafety	Not applicable asUINCARE HOME is asoftware product	Not applicable asRecovr RehabilitationSystem is a softwareproduct	Not applicable asVera™ is a softwareproduct	Same
ChemicalSafety	Not applicable asUINCARE HOME is asoftware product	Not applicable asRecovr RehabilitationSystem is a softwareproduct	Not applicable asVera™ is a softwareproduct	Same
RadiationSafety	Not applicable asUINCARE HOME is asoftware product	Not applicable asRecovr RehabilitationSystem is a softwareproduct	Not applicable asVera™ is a softwareproduct	Same
Sterility	Not applicable asUINCARE HOME is asoftware product	Not applicable asRecovr RehabilitationSystem is a softwareproduct	Not applicable asVera™ is a softwareproduct	Same

Table 1. Technological Characteristics Comparison

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906 UINCARE

A-603, 131, Gasan digital 1-ro, Geumcheon-gu, Seoul, 08506, Republic of Korea Tel) +82-2-6265-0944, Fax) +82-2-6265-0945

K172882 Page 4/6

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Ubuincure

A-603, 131, Gasan digital 1-ro, Geumcheon-gu, Seoul, 08506, Republic of Korea Tel) +82-2-6265-0944, Fax) +82-2-6265-0945

K172882 Page 5/6

Table 2. Safety Comparison

Non-Clinical Test Summary

1. Performance Test Range of Motion Assessment Test
  Performance tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the allowable deviation.
1. Software Validation
  UINCARE HOME contains MODERATE level of concern software was designed and developed according to a software development process and was verified and validated.

Software information is provided in accordance with FDA guidance: the content of premarket submissions for software contained in medical devices, issued on May 11, 2005.

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K172882 Page 6/6

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 device.

Clinical Test Summary:

No clinical studies were considered necessary and performed.

9. Conclusion [21 CFR 807.92(b)(3)]

The UINCARE HOME and the predicate devices are substantially equivalent in terms of intended use and performance, technology and safety. Both platforms are software systems utilizing optical position recording for physical rehabilitation exercises that use the Microsoft Kinect Sensor. Both systems require patient assessment and exercise guidance 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 Sensor.

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.