The AMC Health VitalCaregiving System II ("VitalCaregiving System II") is intended to be used in conjunction with biometric measuring devices, mobile applications and questionnaires to collect and store data, and for clinician scheduled monitoring at home and in non-acute medical facilities. The VitalCaregiving System II securely sends data from a patient monitoring device to a central electronic log of patient information, from which notifications/alerts and reports can be generated and data can be securely viewed by authorized caregivers and patients. Clinicians would then determine how and when to respond to the alerts/notifications and biometric data. For use by adults 18 years and older who do not have an acute care or emergency health care condition.

Data can be sent via intranet networks, the internet, landline and cellular telephones and other mobile devices.
• The software also supports communication between patients and caregivers or researchers, such as bidirectional audio and video e-visits, telephone and mobile text messaging.

The VitalCaregiving System II is not intended for use in emergency situations or by a patient in an acute care medical facility and is not for active patient monitoring.

Device Description

The AMC Health VitalCaregiving System II ("VitalCaregiving System II") is a software only device. VitalCaregiving System II enables clinicians and patients to conduct bidirectional audio-video conversations and collects patient-reported outcomes and self-care activities via assessment questionnaires. Biometric measurements using third party devices can be taken by the patient while being observed over videoconference by a clinician who is located remotely, or measurements can be made by the patient at any time, without being observed by a clinician. Clinicians can also use VitalCaregiving System II to exchange messages with patients by text or telephone.

The system is indicated when health professionals wish to directly interact with patients via video, voice and/or text, and/or view reports of medical parameters collected from patients with non-acute conditions using remote biometric measuring devices and questionnaires. The AMC system is not intended for use in emergency situations.

AI/ML Overview

The provided document is a 510(k) summary for the AMC Health VitalCaregiving System II. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than detailing specific acceptance criteria and a dedicated study proving performance against those criteria. As such, much of the requested information about a specific study proving the device meets acceptance criteria is not present.

However, I can extract information related to how performance was generally validated.

Here's the breakdown of available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, etc. Instead, it states that the device's performance was evaluated by confirming its conformance with specifications through "software verification and validation testing."

The "Performance" section (page 11) states:
"The Vital Caregiving System II is a software only device and the validation and verification testing were performed under the company’s Design Control Process. This device meets all necessary software verification requirements in 21 CFR 820.3(z) and (aa) and 820.30(f) and (g), as described in "General Principles of Software Validation; Final Guidance for Industry and FDA Staff." The testing has confirmed the device's conformance with specifications."

Essentially, the acceptance criterion implicitly is "conformance with specifications" and the reported performance is "testing has confirmed conformance." There are no quantitative metrics or specific performance thresholds provided in this document.

The "Comparison Table" (page 5) compares the subject device with predicate devices across various functional characteristics. While not a performance metric table, it demonstrates that the subject device either matches or extends the capabilities of the predicates, implying that its performance in these functional areas is at least equivalent.

Feature/Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
For all functionalities	Conformance with specifications (software verification requirements in 21 CFR 820.3(z), (aa), 820.30(f), (g), and "General Principles of Software Validation; Final Guidance for Industry and FDA Staff")	"The testing has confirmed the device's conformance with specifications."
Intended Use	Same as predicate devices	"The Vital Caregiving System II has the same intended use as the predicate devices."
Technological Characteristics & Functionality	Comparable or enhanced compared to predicate devices	"The technology and performance characteristics for the Vital Caregiving System II are also the same as the predicate." (Refers to comparison table on page 5)
Compatibility with Third-Party Devices (example for a few categories)	Successful collection and verification of physiological measurements from listed devices	Listed a variety of third-party devices from which the VitalCaregiving System II successfully obtains and verifies physiological measurements (e.g., blood pressure, pulse, weight, oxygen saturation, glucose, temperature)
	Successful collection of non-physiological measurements from listed devices	Listed a variety of third-party devices from which the VitalCaregiving System II successfully obtains non-physiological measurements (e.g., medication dispensed, PERS unit activated)

2. Sample size used for the test set and the data provenance

This information is not provided in the document. The document refers to "software verification and validation testing" but does not specify the sample size of any data used for these tests, nor its provenance (country of origin, retrospective/prospective).

3. 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 document refers to "conformance with specifications" but does not detail how "ground truth" might have been established for any data used in testing.

4. Adjudication method for the test set

This information is not provided in the document.

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

A MRMC comparative effectiveness study was not done or at least not reported in this document. The device is a "software-only device" for data storage, collection, and transmission, and also facilitates communication and e-visits. It is not an AI-assisted diagnostic or interpretive tool where "human readers improve with AI vs without AI assistance" would be a relevant metric.

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

The document describes the "VitalCaregiving System II" as a "software only device." The performance reported is that "The testing has confirmed the device's conformance with specifications." This implicitly describes the standalone performance of the software in terms of its ability to collect, store, transmit, and display data as per its design. However, there are no specific standalone performance metrics (e.g., accuracy of data transmission, latency) provided.

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

The document does not explicitly state the "type of ground truth" used for testing. Given that it's a data collection and transmission system, the "ground truth" would likely relate to the accurate capture, storage, and transmission of biometric data from connected devices, and the correct functioning of communication features. This would typically be validated against expected output values or successful communication logs, rather than clinical 'ground truth' in the diagnostic sense.

8. The sample size for the training set

This information is not provided in the document. As this is a 510(k) for a data management and communication system built upon established technology, it's unlikely to involve a "training set" in the machine learning context. The validation focuses on software engineering principles and functional testing.

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

This information is not provided in the document. (Refer to point 8).

In summary, the provided document is a regulatory submission focused on substantial equivalence and compliance with software validation requirements. It does not contain the detailed clinical or performance study information typically associated with AI/ML diagnostic devices, which would require specific acceptance criteria, test sets, and reader studies. The "study" mentioned generally refers to internal "software verification and validation testing" demonstrating adherence to design specifications and regulatory guidelines for software.

Summary

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Public Health Service

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

September 9, 2016

AMC Health Jonathan Shankman Sr. VP. Clinical Innovation 39 Broadway, Suite 540 New York, New York 10006

Re: K151839

Trade/Device Name: AMC Health VitalCaregiving System II Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer and Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: July 1, 2015 Received: July 6, 2015

Dear Jonathan Shankman:

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 (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 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 vours.

Mada Jellman
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) K151839

Device Name AMC Health VitalCaregiving System II

Indications for Use (Describe)

The AMC Health VitalCaregiving System II ("VitalCaregiving System II") is intended to be used in conjunction with biometric measuring devices, mobile applications and questionnaires to collect and for clinician scheduled monitoring at home and in non-acute medical facilities. The VitalCaregiving System II securely sends data from a patient monitoring device to a central electronic log of patient informations/alerts and reports can be generated and data can be securely viewed by authorized caregivers and patients. Clinicians would then determine how and when to respond to the alerts/notifications and biometric data. For use by adults 18 years and older who do not have an acute care or emergency health care condition.

· Data can be sent via intranet networks, the internet, landline and cellular telephones and other mobile devices.

· The software also supports communication between patients and caregivers or researchers, such as bidirectional audio and video e-visits, telephone and mobile text messaging.

The VitalCaregiving System II is not intended for use in emergency situations or by a patient in an acute care medical facility and is not for active patient monitoring.

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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510(K) SUMMARY

Prepared September 8, 2016

Submitted by: Jonathan Shankman

Contact Person: Jonathan Shankman Telephone: 212-422-3037 Email: jshankman@amchealth.com Product Name: AMC Health VitalCaregiving System II

Common Name: Patient Monitoring System

Classification: Cardiovascular, MWI, 21 CFR 870.2300; DXH, 21 CFR 870.2920

Predicate Device: Advanced Monitored Caregiving VitalCaregiving System and AirStrip Remote Patient Monitoring

Intended Use:

The AMC Health VitalCaregiving System II is a software-only device used alongside vital signs monitoring devices for data storage, collection and transmission.

Indications for Use:

Data can be sent via intranet networks, the internet, landline and cellular telephones and other mobile devices.
• The software also supports communication between patients and caregivers or researchers, such as bidirectional audio and video e-visits, telephone and mobile text messaging.

The VitalCaregiving System II is not intended for use in emergency situations or by a

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K151839

patient in an acute care medical facility and is not for active patient monitoring.

Device Description:

Comparison with Predicate Devices:

The submission device and the predicate device have substantially equivalent intended use and technological specifications.

COMPARISON TABLE

The following table provides a comparison of indications for use, technological characteristics, and functionality.

	Predicate Device:	Predicate Device:	Subject Device:
	Advanced Monitored Caregiving	AirStrip RPM Epiphany	AMC Health
	VitalCaregiving System I	Adapter	VitalCaregiving System II
510(k) Number	K051544	K133450
FDA Classification	Transmitters And Receivers,	Monitor, Physiological,	Transmitters And
	Electrocardiograph, Telephone	Patient (Without	Receivers,
		Arrhythmia Detection Or	Electrocardiograph,
		Alarms)	Telephone; Monitor,
			Physiological, Patient
			(Without Arrhythmia
			Detection or Alarms)
ClassificationCode	DXH	MWI	MWI; DXH
RegulationNumber	870.2920	870.2300	870.2300; 870.2920
Intended Use	The Advanced Monitored Care(

	the measured parameters from apatient's home to a central computervia an intermediary organization,where reports can be generated forthe physician and data can bereviewed over the Internet byphysicians and patients.	information is generatedby other medical devicesand patient informationsystem, and not by AirStripRPM. AirStrip RPMcaptures this informationfrom these other systemsand displays it forclinicians.	monitoring devices fordata storage, collectionand transmission.
Indication for Use	The Advanced Monitored Care("AMC") System is intended to beused in conjunction with homepatient measuring devices to sendthe measured parameters from apatient's home to a central computervia an intermediary organization,where reports can be generated forthe physician and data can bereviewed over the Internet byphysicians and patients.	AirStrip RPM is intended tobe used by clinicians forthe following purposes:1. By using a cellulartelephone or otherdevice on whichAirStrip RPM isinstalled, to reviewphysiologic data of apatient when theclinician is not at thehospital;2. To view the near real-time waveformsremotely;3. To remotely reviewother standard orcritical near real-timepatient data from themonitored system;To provide a request forremote consultationregarding a patient'swaveform or other data.AirStrip RPM is softwarecapable of displayingphysiologic and otherpatient information. Thisinformation is generatedby other medical devicesand patient informationsystem, and not by AirStripRPM. AirStrip RPMcaptures this informationfrom these other systemsand displays it forclinicians.AirStrip RPM is intended tobe used by clinicians forthe following purposes:4. By using a cellular	The AMC HealthVitalCaregivingSystem II("VitalCaregivingSystem II") isintended to beused inconjunction withbiometricmeasuringdevices, mobileapplications andquestionnaires tocollect and storedata, and forclinician scheduledmonitoring athome and in non-
		telephone or other	acute medical
		device on which	facilities. The
		AirStrip RPM is	VitalCaregiving
		installed, to review	System II securely
		physiologic data of a	sends data from a
		patient when the	patient monitoring
		clinician is not at the	device to a central
		hospital;	electronic log of
	5.	To view the near real-	patient
		time waveforms	information, from
		remotely;	which
	6.	To remotely review	notifications/alerts
		other standard or	and reports can be
		critical near real-time	generated and
		patient data from the	data can be
		monitored system;	securely viewed by
	7.	To provide a request	authorized
		for remote	caregivers and
		consultation regarding	patients.
		a patient's waveform	Clinicians would
		or other data.	then determine
			how and when to
			respond to the
			alerts/notifications
			and biometric
			data. For use by
			adults 18 years
			and older who do
			not have an acute
			care or emergency
			health care
			condition.

			• Data can be sent
			via intranet
			networks, the
			internet, landline
			and cellular
			telephones and
			other mobile
			devices.
			• The software
			also supports
			communication
			between patients
			and caregivers or
			researchers, such
			as bidirectional
			audio and video e-
			visits, telephone
			and mobile text
			messaging.


Intended Users	Patients and physicians	Clinicians, when theycannot be at the hospital	TheVitalCaregivingSystem II is notintended for use inemergencysituations or by apatient in an acutecare medicalfacility and is notfor active patientmonitoring.
Available over thecounter	No	No	No
Standard 60601-2-47 MedicalElectricalEquipment	N/A	N/A	"This standard does notapply to systems that donot continuously recordand analyze the ECG (forexample, 'intermittentevent recorders')."The VitalCaregivingSystem II does notcontinuously record andanalyze ECG.
Standard EC53ECG Trunk Cablesand PatientLeadwires	N/A	N/A	The VitalCaregivingSystem II does not use anyECG trunk cables orPatient lead wires. Thereis no electrical connectionto the patient.
Standard 11073-10406 HealthInformatics	N/A	N/A	The VitalCaregivingSystem II is not a basic 1-to 3-lead ECG.
Clinicians,researchers, carecoordinators,patients and theirinformalcaregiver(s) cansecurely accessthe informationhub and/ormobileapplication viathe Internet byusing a unique	Yes	Yes	Clinicians, researchers,care coordinators,patients and theirinformal caregiver(s) cansecurely access theinformation hub and/ormobile application via theInternet by using a uniqueusername and strongpassword
username andstrong password
Data Acquisition:Medical devicedata is obtainedfrom a patient'sdevice throughseveral potentialgateways, such asthe wired orwireless modem,a mobile phoneor tablet, acellular-enabledmedical device ora partner serviceapplication.	Yes	Yes	Yes, and in addition, AMChas established pathwaysfor each gateway toextract data from themedical device and inputit into AMC's cloud-baseddata center.
DataTransmission:medical devicedata is securelytransferred viaInternet betweenproviders and thehub.	Yes	Yes	Yes, in addition, AMCused an encryptedtransport technology withredundant, privateconnections between thenetwork providers andAMC's cloud-based datacenter.
DataStorage/Access:Securely storesand managesencrypted patientmeasurementsmedical devicedata is availablethrough theinterface ofchoice for thepatient,physicians, orother partners tosecurely accessthe patient'sinformation.	Yes	Yes	Yes, in addition, after theAMC Platform hasreceived the transmission,the patient's informationis available in a number oftabular and graphicalviews, providing adetailed analysis of thedata. The patient'scaregiver(s) utilize theseanalyses to evaluate thepatient's health status.
PatientEngagement: Thesystem facilitatesinteractivepatientengagement viaseveral potentialgateways, such assecure	Yes	Yes	Yes, in addition AMCprovides for interactiveeVisits between patient/caregiver and clinician.Generates alerts,notifications, reports anddashboards for patientsand authorized caregivers.Patients and caregiverscan both enter
interactive voiceand videoresponse (IVVR).			information into thepatient record via mobileand web user interfaces.All user interactions arelogged with rich meta-data audit.
Data Integration	Yes	Yes	Yes: On a scheduled ornear real-time basis, thesystem securely transferspatient information to 3rdparty applications, such aselectronic health records(EHR), personal healthrecords (PHR) andelectronic data capture(EDC)

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K151839

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K151839

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The VitalCaregiving System II is compatible with the Samsung Note 2 and Samsung Note 3 for the following functions: eVisit; eMessage; and Mobile Surveys.

The VitalCaregiving System II is compatible with the Samsung Note 2 for the collection of biometric data with the following third-party devices:

1. A&D 351-PBT-ci Weight scale

2. Choicemed MD300C318T2 Pulse Oximeter

The VitalCaregiving System II cannot be used to collect biometric data with the Samsung Note 3.

Third Party Measurement Devices (reference devices)
The Subject Device has been Testedwith the Following Third-PartyDevices:	PhysiologicalMeasurementsObtained andVerified bySubject Devicefrom Third-PartyDevice	Non-PhysiologicalMeasurements Obtained bySubject Device from Third-Party Device
1. A&D UA-851PBT	Systolic pressure;diastolic pressure;pulse rate
2. A&D UA-767	Systolic pressure;diastolic pressure;pulse rate
3. A&D UA-851PBT	Systolic pressure; diastolic pressure; pulse rate
4. A&D UA-767PBT-Ci	Systolic pressure; diastolic pressure; pulse rate
5. IEM Stabilo-Graph BP Monitor	Systolic pressure; diastolic pressure; pulse rate
6. ForaCare D40 Blood Pressure / Glucometer	Systolic pressure; diastolic pressure; pulse rate; Blood Glucose
7. A&D UC-321PBT	Weight
8. A&D UC-351PBT-Ci	Weight
9. A&D UC-352PBT-Ci	Weight
10. A&D UC-355PBT-Ci	Weight
11. ForaCare W320	Weight
12. Omron HBF-510	Weight
13. A&D UT-302PBT	Thermometer
14. Foracare IR20b	Thermometer
15. ChoiceMMed MD300C318T2 O2 Sensor	Oxygen saturation; pulse rate;
16. Nonin 3230 Pulse ox	Oxygen saturation; pulse rate;
17. Nonin 9560 Pulse ox	Oxygen saturation; pulse rate;
18. Propeller Health Inhaler Monitor for Metered Dose Inhalers	n/a	Medication (i.e. puff) dispensed
19. Propeller Health Inhaler Monitor for Respimat	n/a	Medication (i.e. puff) dispensed
20. Propeller Health Inhaler Monitor for Discus Inhalers	n/a	Medication (i.e. puff) dispensed
21. Insung HiCare HX-461 TeleVideo Gateway with internal blood pressure monitor	Systolic pressure, diastolic pressure, pulse rate
22. Coag-sense PT/INR Monitoring System	PT/INR
23. Dongjin i-Scope Stethoscope	n/a	n/a
24. Medminder Maya	n/a	Medication Dispenser data
25. Medminder Jon	n/a	Medication Dispenser data
26. MXD3G Rescue Alert PERS	n/a	PERS unit activated
27. Climax	n/a
28. H3G-700 GPRS GATEWAY	n/a
29. H3G-650 CDMA GATEWAY	n/a
30. H3G-800 CDMA GATEWAY	n/a
31. Aerotel Telemodem Gateway	n/a
32. Qualcomm 2Net Hub	n/a
33. H3 BA-100 (J&J) GlucoseMeter Adaptor	Glucose level
34. H3 BA-110 (Nipro) GlucoseMeter Adaptor	Glucose level
35. H3 BA-110 (Bayer) GlucoseMeter Adaptor	Glucose level
36. H3 BA-110 (Abbott) GlucoseMeter Adaptor	Glucose level
37. Glooko MeterSync BlueGlucose Meter Adaptor	Glucose level

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Performance:

The Vital Caregiving System II is a software only device and the validation and verification testing were performed under the company's Design Control Process. This device meets all necessary software verification requirements in 21 CFR 820.3(z) and (aa) and 820.30(f) and (g), as described in "General Principles of Software Validation; Final Guidance for Industry and FDA Staff." The testing has confirmed the device's conformance with specifications. The specifications do not include any significant differences from those of the predicates.

Conclusion:

The Vital Caregiving System II has the same intended use as the predicate devices. As can be seen from the comparison data and evaluations, the technology and performance characteristics for the Vital Caregiving System II are also the same as the predicate. The Vital Caregiving System II is substantially equivalent to the predicate.

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).