The Wellaho™ Personalized Outpatient Management System is an accessory software application that is used by patients in non-clinical settings (e.g. home), to collect, record and transmit their physiological information to a remote secure server. Stored data is accessible by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. The Wellaho is also intended to be used in combination with a variety of external vital sign devices. The Wellaho Personalized Outpatient Management System does not measure, interpret or make any decisions on the data that it conveys. It is not intended as a replacement for the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring.

Device Description

Wellaho Personalized Outpatient Management System is a software system that collects patient physiological data (such as blood pressure and blood sugar levels) for transmission to a secure central storage server, which can be accessed by health care professionals for analysis and intervention using standard digital communication technologies and protocols. These data are also available to the patient for viewing purposes and as an aid in maintaining wellness regimens.

AI/ML Overview

The provided FDA 510(k) summary for the Wellaho Personalized Outpatient Management System does not include a detailed study proving the device meets specific acceptance criteria. The document focuses on demonstrating substantial equivalence to a predicate device (Vignet Tele-Health Manager, K113446) rather than presenting a performance study with defined acceptance criteria.

The device itself is described as a software system that collects, records, and transmits physiological data from patients in non-clinical settings to a remote secure server for healthcare professionals to access and analyze. Crucially, the document states: "The Wellaho Personalized Outpatient Management System does not measure, interpret or make any decisions on the data that it conveys." This indicates it's a data transmission and storage system, not a device that makes diagnoses or interpretations from the data.

Therefore, many of the questions regarding acceptance criteria, study design, ground truth, and reader studies (which are typically relevant for diagnostic or AI-driven interpretive devices) are not applicable or cannot be answered from the provided text for this specific device.

However, based on the information provided, we can infer the primary "acceptance criterion" for this type of device in the context of a 510(k) submission is substantial equivalence to a predicate device in terms of intended use, technology, and safety/effectiveness.

Here’s a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from 510(k) process for this device type)	Reported Device Performance (from 510(k) summary)
Functional Equivalence: Ability to collect, record, and transmit physiological data to a secure central storage server.	The Wellaho Personalized Outpatient Management System is a software system that collects patient physiological data (such as blood pressure and blood sugar levels) for transmission to a secure central storage server. Stored data is accessible by healthcare professionals for analysis and intervention.
Data Accessibility: Data can be accessed by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols.	Stored data is accessible by healthcare professionals for analysis and intervention using standard digital communication technologies and protocols. Data is also available to the patient for viewing purposes.
Combination with External Devices: Intended to be used with a variety of external vital sign devices.	The Wellaho is also intended to be used in combination with a variety of external vital sign devices.
Non-Interpretive: Does not measure, interpret, or make any decisions on the data it conveys.	The Wellaho Personalized Outpatient Management System does not measure, interpret or make any decisions on the data that it conveys. It is not intended as a replacement for the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring.
Security: Transmits data to a secure central storage server.	...transmission to a secure central storage server...
Substantial Equivalence to Predicate Device (Vignet Tele-Health Manager, K113446)	"The Wellaho Personalized Outpatient Management System is substantially equivalent (SE) to the predicate device, the Vignet Tele-Health Manager." A comparison table (not provided in this excerpt) was included in the submission to support this.

2. Sample size used for the test set and the data provenance:
Not applicable/Not provided. The 510(k) summary for this type of device (a data transmission system) does not typically require a "test set" in the sense of clinical data validation for diagnostic performance. The primary "test" is demonstrating functional equivalence to the predicate and adherence to cybersecurity/data handling standards, which are not detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/Not provided. This device does not generate interpretations or decisions that would require expert-established ground truth in a clinical validation study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/Not provided for the same reasons as above.

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:
Not applicable. This is not an AI-driven or diagnostic support system. It is a data transmission system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device's "performance" is in its ability to securely collect and transmit data, not in an algorithmic interpretation. The document explicitly states it "does not measure, interpret or make any decisions."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. Ground truth for clinical outcomes or diagnoses is not relevant for this device's function as described.

8. The sample size for the training set:
Not applicable. As a data transmission and storage system, there is no "training set" in the context of machine learning or AI models.

9. How the ground truth for the training set was established:
Not applicable for the same reason as above.

Summary

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Premarket Notification [510(k)] Summary

JAN 1 6 2013

Device details	Name Trade:	Wellaho Personalized Outpatient ManagementSystem
	Common name:	Telemedicine System
	Classification name:	Radiofrequency Physiological SignalTransmitter and Receiver
	Regulation number:	870.2910
	Product code:	DRG
	Classification panel:	Cardiovascular Devices
	Classification:	Class II device
Submitter:	Sanitas, Inc.
	1640 El Camino Del Teatro
	La Jolla, CA 92037
	Tel: 858-945-0660

Intended Use

Contact person:

Mr. Naser Partovi, CEO

Indication for Use

Predicate Device Information:

The Wellaho Personalized Outpatient Management System is of comparable type and is

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substantially equivalent to the following legally marketed predicate device:

Company	Device	510 (k)
Vignet Corporation	Vignet Tele-Health Manager	K113446

In further support of substantial equivalency, Section 12 provides a comparison table of the Wellaho Personalized Outpatient Management System and the predicate device.

The Wellaho Personalized Outpatient Management System is substantially equivalent (SE) to the predicate device, the Vignet Tele-Health Manager.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is written in a sans-serif font. The logo is black and white.

Public Health Service

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

JAN 1 6 2013

Sanitas, Inc c/o Mr. Alan Donald, MS, MBA, FRAPS 11440 W. Bernardo Court Suite 300 San Diego, CA 92127

Re: K123671

Trade/Device Name: Wellaho Personalized Outpatient Management System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II Product Code: DRG Dated: November 28, 2012 Received: November 29, 2012

Dear Mr. Donald:

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 - Mr. Alan Donald

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.

Sincerely yours,

Owen P. Faris -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 Statement 4

510(k) Number:

Device Name: Management System Wellaho™ Personalized Outpatient

Indications For Use:

Prescription

Prescription Use

AND/OR

Over-The-Counter Use XX

(21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number R/2367/

Page 15 Premarket Notification - Wellaho™ Personalized Outpatient Management System [510(k)] Submission November 28, 2012

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).