The LG SmartHealth is intended to collect vital sign measurement devices intensurement devices intended for use in the home . Patients can review the stored vital sign measurement information and motivational content from caregivers(or nurse). Patients can also engage in video conferences with caregivers(or nurse).

The LG SmartHealth is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required.

The LG SmartHealth is contraindicated for patients requiring direct-medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.

Device Description

The LG SmartHealth application is software planned to operate on the Android operating system (OS) that can be loaded as an application or "app" on a commercially available smartphone. LG intended the software to work on the Android OS, as well as to operate on smartphones as well. The scalability and differences between many smartphones today are not too great to allow this flexibility and option.

The LG SmartHealth application connects to commercially available wireless medical devices that are commonly used by patients in a home-care setting. These "sensor devices" are FDA cleared or FDA registered (Exempt) devices that can communicate with the LG SmartHealth application software loaded on the smartphone using Bluetooth connectivity. To avoid wireless interference and confusion on the part of the patient, serial readings are performed (i.e. only one Bluetooth sensor used at a time) and MAC address filtering is used for the various medical devices. The LG SmartHealth application plans to support the following sensor available medical devices, some initially, and others as the technology becomes available:

-Glucose meters or glucometers
-Blood pressure cuffs
-Weight scales
-Body fat readers
-Activity monitors

On each screen of the LG SmartHealth application software a help button is present, which when pressed provides step-by-step based help to guide a patient through an interaction.

The medical device takes a reading depending on the frequency previously established and the LG SmartHealth application software fetches the information for the reading automatically. The LG SmartHealth application software stores and displays the information on the smartphone and transmits the information to the server. The LG SmartHealth application encrypts the information in preparation for transmit using SHA256 bit encryption, complying with HIPAA requirements.

AI/ML Overview

The provided document is a 510(k) premarket notification for the LG SmartHealth device. It primarily focuses on demonstrating substantial equivalence to a predicate device (Intel Health Guide Express K103276) rather than providing detailed acceptance criteria and a comprehensive study report for the LG SmartHealth directly.

Based on the information within the document, here's what can be extracted and inferred regarding acceptance criteria and studies:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" with quantitative metrics for the LG SmartHealth's performance in the typical sense (e.g., sensitivity, specificity, accuracy for a diagnostic device). Instead, it discusses meeting software design specifications and demonstrating substantial equivalence. The "performance" is largely described in terms of software functionality, usability, and hazard mitigation.

Acceptance Criteria (Inferred from document)	Reported Device Performance
Software Performance:
- Meets established Software Design Specifications.	"The software was tested against the established Software Design Specifications for each of the test plans to assure the device performs as intended.""The testing results support that all the software specifications have met the acceptance criteria of each module and interaction of processes.""The LG SmartHealth device passed all testing..."
- Performs as intended.	(Implicitly stated above)
- Safe operation.	"...and supports the claims of substantial equivalence and safe operation."
- Hazard analysis completed and risks mitigated.	"The device Hazard analysis was completed and risk control implemented to mitigate identified hazards."
Usability Performance:
- Comprehension by users (nurses and participants).	"The study demonstrated: Comprehension of the study nurses and participants with the LG SmartHealth..."
- Appropriate human factors.	"The study demonstrated:... Appropriate human factors related to the LG SmartHealth..."
- Ease of use.	"The study demonstrated:... Ease of use of the LG SmartHealth."
Functional Equivalence:
- Similar data collection software functionality.	"Both devices have the same data collection software functionality..."
- Similar communication method of patient device with central server.	"Both devices have the same... communication method of patient device with central server..."
- Similar types of sensors interfaced, implementation methods, connectivity, protocol.	"Both devices have the same... types of sensors which can be interfaced to the patient device, implementation method of collecting data from sensors, sensor software, connectivity, and communication protocol." (Note: some differences in specific supported device types are listed, e.g., predicate supports Pulse Oximeter and FEV/PEF, while subject supports Temperature and Activity Monitor, but the type of interfacing is stated as similar.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Software Testing: The document states that "The device's software development, verification, and validation have been carried out in accordance with FDA guidelines." It mentions testing against "each of the test plans." It does not provide specific sample sizes (e.g., number of test cases, number of runs) for the software verification and validation.
Usability Study: The document explicitly mentions a "usability study of the LG SmartHealth under actual use." It states the study involved "study nurses and participants." However, it does not specify the sample size for nurses or participants, nor does it mention the country of origin or whether it was retrospective or prospective. It is implied to be a prospective study ("under actual use").
Clinical Performance Data: The document explicitly states, "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." Therefore, no sample size for a clinical test set is provided.

3. 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)

For the software testing directly, the "ground truth" would be the expected output or behavior defined by the Software Design Specifications. This doesn't involve external human experts in the context of diagnostic interpretation.
For the usability study, the "ground truth" would implicitly be the observed comprehension, human factors, and ease of use. This would be established by the study design and observation, but the document does not mention specific experts or their qualifications contributing to establishing this "ground truth" (e.g., human factors engineers evaluating the results). The "study nurses" participated in the study; it's not stated they established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any adjudication method for either the software testing or the usability study results. The software testing seems to rely on automated or manual verification against specifications, and the usability study on observation and possibly participant feedback.

5. 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. The LG SmartHealth is described as a "Remote Patient Monitoring System" that collects vital signs and facilitates communication/education. It is not an AI-assisted diagnostic or interpretive device, and therefore, an MRMC comparative effectiveness study involving human readers improving with/without AI assistance is not applicable and was not performed or mentioned. The device explicitly states it "is not interpretive, nor is it intended for diagnosis or as a substitute for medical care."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is essentially a software application that collects, stores, displays, and transmits vital sign data from other FDA-cleared/registered medical devices. Its primary function is data management and communication facilitating human care. It does not perform an "algorithm only" diagnostic or interpretive function in the sense that AI-driven diagnostic tools do. The software's performance was validated against its design specifications and its usability was evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For software testing: The ground truth was the established Software Design Specifications – essentially, the predefined correct behavior and output of the software modules.
For usability study: The ground truth was observed comprehension, human factors, and ease of use based on participant interaction and feedback during the study.

8. The sample size for the training set

Not applicable/Not mentioned. The LG SmartHealth is not described as an AI/ML device that requires a "training set" for model development. Its software operation is rule-based and functional, focused on data collection, storage, and transmission, rather than learning from data.

9. How the ground truth for the training set was established

Not applicable. As no training set is mentioned for an AI/ML model, this question does not apply.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other.

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

November 21, 2014

LG Electronics c/o Ms. Diane Sudduth Senior Consultant, RA/Q/A 816 Congress Avenue, Suite 1400 Austin, TX 78701

Re: K133997

Trade/Device Name: LG SmartHealth Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: Class II Product Code: DRG Dated: November 19, 2014 Received: November 20, 2014

Dear Ms. Sudduth:

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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Page 2 - Ms. Diane Sudduth

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 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/Resourcesfor You/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,

Melissa A. Torres -S

For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K133997

Device Name

LG SmartHealth

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)

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)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510(k) Summary

for

LG SmartHealth

1. Submission Sponsor

LG Electronics 38 Baumoe-ro, Seocho-gu Seoul, 137-724 Korea Phone: +82-2-526-4527 Fax: +82-2-526-4370 Contact: Chang Hee Lee, Chief Research Engineer

2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (561) 305-5075 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Dr. Diane Sudduth, Senior Consultant, QA Email: project.management@emergogroup.com

3. Date Prepared

December 21, 2013

4. Device Identification

Trade/Proprietary Name:	LG SmartHealth
Common/Usual Name:	Remote Patient Monitoring System
Classification Name:	Transmitters and Receivers, Physiological SignalRadiofrequency
Classification Regulation:	870.2910
Product Code:	Product Code DRG
Device Class:	Class II
Classification Panel:	Cardiovascular

5. Legally Marketed Predicate Device(s)

Intel Health Guide Express (K103276)

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6. Device Description

-Glucose meters or glucometers
-Blood pressure cuffs
-Weight scales
-Body fat readers
-Activity monitors

On each screen of the LG SmartHealth application software a help button is present, which when pressed provides step-by-step based help to guide a patient through an interaction.

7. Indication for Use Statement

The LG SmartHealth is intended to collect vital sign measurements from physiological measurement devices intended for use in the home. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers (or nurse). Patients can also engage in video conferences with caregivers (or nurse).

The LG SmartHealth is contraindicated for patients requiring direct-medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing

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its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.

8. Substantial Equivalence Discussion

The comparison chart below provides evidence to facilitate the substantial equivalence determination between LG SmartHealth to the predicate device (K103276) with respect to intended use, technological characteristics and principles of operation.

Features andSpecifications	Intel® Health Guide Express(K103276)	LG SmartHealth(Subject Device)
Regulatory Information
Intended Use/ Indications forUse	The Intel® Health Guide Express is intendedto collect vital sign measurements fromphysiological measurement devicesintended for use in the home.Patients can review the stored vital signmeasurement information and receiveeducational and motivational content fromcaregivers. Patients can also engage invideo conferences with caregivers andanswer the caregivers' questions byparticipating in surveys.The Intel® Health Care Management Suiteallows the caregiver to review patient dataand initiate video conferencing withpatients, or select and send educational andmotivational content to patients.The Intel® Health Guide Express is notinterpretive, nor is it intended for diagnosisor as a substitute for medical care, and it isnot intended to provide real time data. It ismade available to patients when time-critical care is not required.The Intel® Health Guide Express iscontraindicated for patients requiring direct-medical supervision or emergencyintervention. It is intended for patients whoare willing and capable of managing its use.Clinical judgment and experience by acaregiver are required to check andinterpret the information delivered.	The LG SmartHealth is intended tocollect vital sign measurementsfrom physiological measurementdevices intended for use in thehome.Patients can review the stored vitalsign measurement information andreceive educational andmotivational content fromcaregivers (or nurse).Patients can also engage in videoconferences with caregivers (ornurse).The LG SmartHealth is notinterpretive, nor is it intended fordiagnosis or as a substitute formedical care, and it is not intendedto provide real time data. It ismade available to patients whentime-critical care is not required.The LG SmartHealth iscontraindicated for patientsrequiring direct-medicalsupervision or emergencyintervention. It is intended forpatients who are willing andcapable of managing its use.Clinical judgment and experienceby a caregiver are required tocheck and interpret theinformation delivered.
OTC and/or Rx	Rx	Same

Table 5A – Comparison of Characteristics

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User Characteristics
Intended User	Patient in Home Setting	Same
Device
Components	Web based software application Data Transfer Tool (Integrated)	Smart phone app based software application Data Transfer Tool (Integrated)
User Interface Device	Computer Device (i.e. desktop, laptop)	Android Device(i.e. Smart phone, tablet)
Connectivity to Device	Bluetooth or USB wired	Bluetooth
Ability to Update Device Settings	Not available	Automatic deploy
Connectivity to Web-based Services	Login Secured by SSL Encryption	Same
Operating System	Microsoft Windows 7 (32-bit versions)	Android 2.3.3 or higher
Supported Device Types	Medical devices designed for home use:Blood glucose meterWeight scaleBlood pressurePulse OximeterFEV/PEF	Medical devices designed for home use:Blood glucose meterWeight scaleBlood pressureTemperatureActivity Monitor
Software Delivery	Web download for the uploader only	Same
Software Features
Patient Management	Manage patient accounts, filter/sort/search patients, print reports.	The server connected to the mobile device manages patient accounts, filter/sort/search patients
Implementation method of collecting data from sensors	Bluetooth or USB wired	Bluetooth
Communication frequency	Bluetooth: 2.402 to 2.480 GHz	Same
Max data throughput under worst case conditions	Multiply read data can be stored in the medical device and they are resent to the server after recovery of network condition	Same
Use ofthresholds/algorithms fordetermining howthresholds are set andchanged	Thresholds set by healthcareprofessional in server software	Same
Communication methodwith server	Connected through internet	Same

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The LG SmartHealth is a medical device and has similar indications for use statement as the predicate device. The differences in the indications statement between LG SmartHealth and Intel Health Guide Express do not alter the intended use – both devices have essentially the same intended use.

The device also has similar technological characteristics as the predicate device. Both devices have the same data collection software functionality, communication method of patient device with central server, types of sensors which can be interfaced to the patient device, implementation method of collecting data from sensors, sensor software, connectivity, and communication protocol. Since the comparison of the descriptive characteristics of the proposed and predicate devices may not be sufficiently precise to assure equivalence, performance data are provided. The results of the performance testing demonstrate substantial equivalence.

9. Non-Clinical Performance Data

The device's software development, verification, and validation have been carried out in accordance with FDA guidelines. The software was tested against the established Software Design Specifications for each of the test plans to assure the device performs as intended. The device Hazard analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria of each module and interaction of processes. The LG SmartHealth device passed all testing and supports the claims of substantial equivalence and safe operation.

Validation activities included a usability study of the LG SmartHealth under actual use. The study demonstrated:

Comprehension of the study nurses and participants with the LG SmartHealth,
Appropriate human factors related to the LG SmartHealth, and ●
Ease of use of the LG SmartHealth.

10. Clinical Performance Data

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The verification and validation testing of the device's software was found to be acceptable and supports the claims of substantial equivalence.

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11. Statement of Substantial Equivalence

The LG SmartHealth has the same or similar intended use as the predicate device and that any technological differences between the LG SmartHealth software and the predicate device do not raise any questions regarding LG SmartHealth')'s safety and effectiveness.

The information provided in this submission supports the substantial equivalence to the predicate device and that the system is safe and effective for the users/operators.

Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).