The Tablet Commander device is for use by patients to collect and transmit general health information, physiological measurements and other data between themselves and a caregiver.

The Tablet Commander makes no diagnosis. Clinical judgment and experience are required to check and interpret the information transmitted. The Tablet Commander is not intended as a substitute for medical care.

Device Description

The Tablet Commander is a software application. Once installed on a commercially-available device, the Tablet Commander software uses standard communication protocols to exchange information with other medical devices (peripherals). Data collected from the medical devices is transmitted back to a database for review by a caregiver. The Tablet Commander software has a user interface which allows the patient and caregiver to communicate using methods which include questions and answers.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Tablet Commander" device, a software application for remote patient monitoring. The application focuses on functional and safety analysis rather than diagnostic accuracy. As such, acceptance criteria and performance metrics related to diagnostic accuracy (like sensitivity, specificity, or AUC) are not applicable or provided in this document.

Here's an analysis based on the information provided:

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

The document does not explicitly state quantitative acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or similar diagnostic measures. Instead, the acceptance is based on the device functioning according to its requirements and specifications, and demonstrating substantial equivalence to predicate devices in terms of intended use, technology, materials, and principles of operation, without introducing new hazards.

The key performance criterion is that the device "functioned according to its requirements and specifications." The validation activities supporting this are described as:

Acceptance Criterion (Implied)	Reported Device Performance
Device functions according to its requirements and specifications	Risk-based verification and validation testing completed.
Adherence to software development standards	Voluntary standard IEC 62304 used as a model for software development.
Substantial equivalence to predicate devices	Basic design principle (application on commercial tablet) is identical to tablet-based predicates. Data structuring and network communication design principles are identical to predicate Commander III. No new hazards to safety or effectiveness presented.

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

The document does not mention a specific "test set" in the context of clinical data or diagnostic performance. The validation appears to be primarily focused on software functionality and engineering verification and validation (V&V) activities. Therefore, details about the sample size for a test set, data provenance, or whether it was retrospective or prospective are not 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)

Since there is no mention of a "test set" requiring ground truth establishment through expert review for diagnostic purposes, this information is not applicable and not provided in the document.

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

Similarly, as there is no diagnostic "test set" needing ground truth establishment, no adjudication method is described.

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 MRMC comparative effectiveness study was conducted or is mentioned, as the device is a remote patient monitoring system and not an AI-assisted diagnostic tool.

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

The Tablet Commander is described as a "software application" that collects and transmits data for review by a caregiver. It explicitly states, "The Tablet Commander makes no diagnosis," and "Clinical judgment and experience are required to check and interpret the information transmitted." This indicates that the device is not intended for standalone diagnostic performance; it functions as a data collection and transmission tool within a human-in-the-loop system. Therefore, a standalone algorithm-only performance study (in a diagnostic sense) was not done, and would not be relevant to its intended use.

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

For the software validation, the "ground truth" implicitly refers to the device's functional requirements and specifications. The V&V testing confirms that the software behaves as designed and meets these predefined requirements, rather than validating against clinical ground truth like pathology or expert consensus on a diagnosis.

8. The sample size for the training set

The document does not describe the use of machine learning or AI models that would require a "training set" for diagnostic algorithm development. The device is a software application for data management and communication.

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

As there is no mention of a training set for machine learning, this information is not applicable and not provided.

Summary of the study and its purpose:

The study described is not a performance study in the typical sense of evaluating diagnostic accuracy using clinical data. Instead, it is a verification and validation (V&V) study of a software application for remote patient monitoring, conducted as part of a 510(k) premarket notification. The purpose was to demonstrate that the "Tablet Commander" software functions according to its requirements and specifications and that it is substantially equivalent to legally marketed predicate devices without raising new questions of safety or effectiveness.

The key study type conducted was risk-based verification and validation testing of the software, following FDA guidances ("Guidance for the Content of Premarket Submissions for software Contained in Medical Devices" and "General Principles of Software Validation") and using IEC 62304 as a model for software development. This type of study focuses on ensuring the software is correctly built (verification) and that it meets specified user needs (validation) within its intended technical scope, rather than clinical efficacy or diagnostic performance. No clinical tests were conducted because the device was considered to present no new hazards to safety or effectiveness compared to predicate devices.

Summary

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K122285

7980 Century Blvd Chanhassen, MN 55317 Toll-Free: 1-888-243-8881

510(k) Summary

AUG 1 4 2012

Submitter:	Cardiocom, LLC7980 Century Boulevard, Chanhassen, MN 55317
Contact Person:	Daniel L. Cosentino, CEO, President, Cardiocom, LLCPhone: 888-243-8881Fax: 888-320-8881
Date Prepared:	Tuesday, May 01, 2012
Trade Name:	Tablet Commander
Common Name	Remote Patient Monitoring System
Classification:	Name: Radiofrequency physiological signal transmitter andreceiverRegulation: 21 CFR §870.2910Panel: CardiovascularClass: II
Product Code:	DRG
Predicate Device(s):	The subject device is equivalent to the following devices:Cardiocom Commander III, K053304; Intel Health Guide Express,K103276; Hommed Genesis Touch, K112858
Device Description:	The Tablet Commander is a software application. Once installed ona commercially-available device, the Tablet Commander softwareuses standard communication protocols to exchange informationwith other medical devices (peripherals). Data collected from themedical devices is transmitted back to a database for review by acaregiver. The Tablet Commander software has a user interfacewhich allows the patient and caregiver to communicate usingmethods which include questions and answers.
Intended Use:	The Tablet Commander device is for use by patients to collect andtransmit general health information, physiological measurementsand other data between themselves and a caregiver.The Tablet Commander makes no diagnosis. Clinical judgment andexperience are required to check and interpret the informationtransmitted. The Tablet Commander is not intended as a substitutefor medical care.

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E X P E R T S

Table 1 – Intended Use Comparison with Predicate Devices

	Submission Device	Predicate #1-K103276Intel Health GuideExpress	Predicate #2-K112858-HoneywellHommed GenesisTouch	Predicate #3-K053304-Commander III
Indicationsfor Use	The TabletCommander device isfor use by patients tocollect and transmitgeneral healthinformation,physiologicalmeasurements andother data betweenthemselves and acaregiver.The TabletCommander makes nodiagnosis. Clinicaljudgment andexperience arerequired to check andinterpret theinformationtransmitted. TheTablet Commander isnot intended as asubstitute for medicalcare.	The Intel Health GuideExpress is intended tocollect vital signmeasurements from thephysiologicalmeasurement devicesintended for use in thehome. Patients canreview the stored vitalsign measurementinformation and receiveeducational andmotivational contentfrom caregivers. Patientscan also engage in videoconferences withcaregivers and answerthe caregivers' questionsby participating insurveys.The Intel Health CareManagement Suiteallows the caregiver toreview patient data andinitiate videoconferencing withpatients, or select andsend educational andmotivational content topatients.The Intel Health GuideExpress is notinterpretive, nor is itintended for diagnosis oras a substitute formedical care, and it isnot intended to providereal time data. It is madeavailable to patientswhen time-critical care isnot required.	The HoneywellHomMed GenesisTouch RetrospectivePhysiologicalMonitoring System isdesigned toretrospectivelymonitor vital signs.Vital signs includenoninvasive bloodpressure,pulse oximetry, pulserate, weight andmanually enteredtemperature. TheGenesis TouchRetrospectivePhysiologicalMonitoring Systemcollects, displays andtransmits vital signsmeasurementscaptured fromcommerciallyavailable FDA clearedwireless medicaldevices designed forhome use. Collectedmeasurement datafrom the GenesisTouch System can betransmitted via acommunicationmodule to a centralviewing station wherethe data can beviewed and analyzedby a healthcareprofessional.The Genesis TouchRetrospectivePhysiologicalMonitoring System isintended for home useby adult and pediatricpatients over twelve	The Commander IIIdevice is for use bypatients to collectand transmit generalhealth questions andpatient vital sign data(such as weight,blood pressure,glucose, pulseoximetry, peak flow)between the patient,typically at home,and a health careprofessional at aremote site.The Commander IIImakes nointerpretation,evaluation, medicaljudgments, orrecommendations fortreatment. Clinicaljudgment andexperience arerequired to checkand interpret theinformationtransmitted. TheTablet Commanderis not intended as asubstitute formedical care.

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K122285

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K122285

EXPERTS | N TELEHEALTH™

contraindicated for	years of age or in a
patients requiring direct	healthcare related
medical supervision or	environment by
emergency intervention.	healthcare providers.
It is intended for patients	The Genesis Touch
who are willing and	Retrospective
capable of managing its	Physiological
use. Clinical judgment	Monitoring System is
and experience by a	not
caregiver are required to	intended for
check and interpret the	emergency use or
information delivered.	real-time monitoring
	and does not have
	auditory or visual
	alarms for out-of-limit
	parameters.

Table 2 – Technology Comparison with Predicate Devices

	Submission Device	Predicate #1-K103276	Predicate #2-K112858	Predicate #3-K053304
BasicTechnologyDescription	The TabletCommander is asoftware applicationcapable of runningon any hardwareplatform that usesthe Androidoperating system.The TabletCommanderinterfaces with otherelectronics includingFDA-clearedmedical devicesusing standard wiredand wirelessprotocols. ManyTablet Commandersthen communicatethat data to a back-end databaseapplication using thepublictelecommunicationsnetwork.	Intel Health GuideExpressThe Intel Health GuideExpress is a softwareapplication capable ofrunning on any hardwareplatform that uses theWindows 7 operatingsystem. The Intel HealthGuide Express interfaceswith other electronicsincluding FDA-clearedmedical devices usingstandard wired andwireless protocols.Many "Guides" thencommunicate that data toa back-end databaseapplication (GuideVirtual Care Suite) usingthe publictelecommunicationsnetwork.	Honeywell HomMedGenesis TouchThe Honeywell HomMedGenesis TouchRetrospectivePhysiological MonitoringSystem is a softwareapplication running on adedicated Commercially-Available Off-the-Shelf(COTS) tablet computer.The "Touch" interfaceswith other electronicsincluding FDA-clearedmedical devices usingstandard wired andwireless protocols. Many"Guides" thencommunicate that data toa back-end databaseapplication (LifeStreamManagement Suite) usingthe publictelecommunicationsnetwork.	Commander IIIThe Commander IIIis an electronicdevice consisting ofa blood pressuresystem and built-inproprietarysoftware whichallows it tointerface with otherFDA-clearedmedical devices.Many CommanderIII's thencommunicate thatdata to a back-enddatabaseapplication usingthe publictelecommunicationsnetwork.
OperatingSystem	Android	Windows 7	Android	Proprietaryfirmware
HardwareCharacteristics	Standard minimumrequirements formobile devices	Standard minimumrequirements for mobiledevices	Standard minimumrequirements for mobiledevices	LCD Display: 240x 320 pixelsCPU: Low speedMicrocontrolerNetwork

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PeripheralInterfaceCharacteristics	The TabletCommander	The Guide	The Touch communicates	POTS or Cellular
	interfaces with theperipheral medicaldevices usingstandard wired andwireless connectionsaccording to theprotocolsestablished by themanufacturer of theperipheral. Theprotocols includechecksums with re-transmit and purgeloops for datavalidation.	communicates with avariety of peripheralsusing standard wired andwireless technologies.	with a variety ofperipherals using standardwired and wirelesstechnologies.	The Commander IIIis integrated with ablood pressuresystem andconnected to otherperipherals usingRS232 serialconnectionsaccording toprotocolsestablished by themanufacturer of theperipheral. Theprotocols includechecksums with re-transmit and purgeloops for datavalidation.

Functional and Safety Analysis:

Risk based verification and validation testing according to FDA guidances "Guidance for the Content of Premarket Submissions for software Contained in Medical Devices" and "General Principles of Software Validation" was completed to ensure the Tablet Commander functioned according to its requirements and specifications. Cardiocom used the voluntary standard IEC 62304 as a model for the software development environment to maintain quality throughout the software lifecycle. The Tablet Commander is identical to the tablet-based predicate devices in that the basic design principle is an application running on a commercial tablet. The data structuring and network communication design principles are identical to the predicate Commander III device. No new hazards to safety or effectiveness are presented by Tablet Commander, therefore, no clinical tests were conducted.

Cardiocom considers the Tablet Commander to be equivalent to the Conclusion: predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials and indications for use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

AUG 14 2012

Cardiocom LLC c/o Mr. Mark Job (Regulatory Technology Services, LLC) 1394 25" Street NW Buffalo, MN 55313

Re: K122285

Trade/Device Name: Tablet Commander Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver. Regulatory Class: Class II (two) Product Code: DRG Dated: July 27, 2012 Received: July 30, 2012

Dear Mr. Job:

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.

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Page 2 - Mr. Mark Job

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sineerely purs,

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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K122285

ﺮ ﺍ

Indications for Use

510(k) Number (if known):

Device Name: Tablet Commander

Indications For Use:

The Tablet Commander device is for use by patients to collect and transmit general health information, physiological measurements and other data between themselves and a caregiver.

Contraindications, Precautions, and Warnings:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use × (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	K122285

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(

ﺎ.

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).