Mobile Application allows the user to collect vital signs data (including noninvasive blood pressure, pulse rate, weight and other data from optional add-on devices). The user can then transmit the data to a central database via a communication network. Use of the system allows retrospective review of certain physiological functions by qualified health care professionals. The Mobile Application is intended for use with adult and pediatric patients over twelve years of age.

Device Description

The Connected Care Mobile Application is intended to receive, display and transmit patient information on a retrospective basis. The device is not intended for real-time monitoring or emergency use by patients or caregivers.

The mobile application is designed to operate on various platforms including tablet computers and smart phones, guiding a user through the vitals acquisition process via Bluetooth medical peripherals. Peripherals will include:

. Scale
Glucose meter
NiBP .
. SPO2

AI/ML Overview

The provided text details the 510(k) summary for the Watermark Medical Connected Care Mobile Application. However, it does not include specific acceptance criteria, a detailed study proving performance against those criteria, or the granular information about sample sizes, ground truth establishment, or expert qualifications that you requested.

The document primarily focuses on the regulatory submission, device description, intended use, and substantial equivalence to a predicate device. The "Performance Data" section is very brief and general.

Here's a breakdown of what can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Explicitly Stated	"The software validation results demonstrated that the Mobile Application was in compliance with the guidelines and standards referenced in the FDA reviewer's guides and that it performed within its specifications and functional requirements for software."
(Implied Criteria based on Device Functionality)	(The device is intended to receive, display, and transmit patient information, specifically vital signs data from connected peripherals.)
Accuracy of data display/transmission	Not explicitly stated, but implicitly validated as part of "specifications and functional requirements."
Data integrity during transmission	Not explicitly stated, but implicitly validated as part of "specifications and functional requirements."
Compatibility with specified peripherals	Not explicitly stated, but implicitly validated as part of "specifications and functional requirements."

Explanation:
The document states that the software validation demonstrated compliance with guidelines and standards, and that it performed within its specifications and functional requirements. However, it does not list these specific specifications or functional requirements as acceptance criteria in measurable terms (e.g., "data transmission success rate > 99%," "display accuracy within X% of source"). Therefore, a detailed table with explicit acceptance criteria and corresponding performance metrics cannot be constructed from the provided text.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not mentioned in the provided text.
Data Provenance (e.g., country of origin, retrospective/prospective): Not mentioned in the provided text. The device is intended for "personal use" and collects data for "retrospective review," implying the data, once collected, is historical. However, details about the origin of data used for testing are absent.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not mentioned in the provided text.
Qualifications of Experts: Not mentioned in the provided text.

4. Adjudication Method for the Test Set

Adjudication Method: Not mentioned in the provided text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No, an MRMC comparative effectiveness study is not mentioned or implied in the provided text. This device is a data collection and display application, not an AI interpretation tool for medical images, which are typically the subject of MRMC studies.
Effect size of human readers with/without AI assistance: Not applicable, as no MRMC study was mentioned and the device is not an AI interpretation tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was a standalone study done? The "Performance Data" section refers to "software validation results" and performance "within its specifications and functional requirements." This implies testing of the software's functionality in isolation (standalone), but no specifics of such a study are provided (e.g., methodology, metrics, results beyond a general statement of compliance).

7. Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated. For a device like this, ground truth would likely involve verifying the accuracy of displayed and transmitted data against the raw data received from the connected physiological sensors. However, the document doesn't detail how this was established.

8. Sample Size for the Training Set

Training Set Sample Size: Not mentioned in the provided text. Given this is a mobile application for data collection and display, it's unlikely to have a "training set" in the sense of machine learning algorithms. The "training" would be more akin to software development and debugging, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment for Training Set: Not applicable in the context of machine learning. If "training set" refers to data used during software development and testing, ground truth would be established by verifying the software's output against the expected correct output for given inputs, likely through various testing methodologies (unit tests, integration tests, system tests). The document does not provide these details.

Summary

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K120325 Pi/2

JUL 1882012

Submitter:	Watermark Medical
Address:	1750 Clint Moore Road, Suite 101Boca Raton, FL 33487
Corporate Contact:	Frank Katarow, Chief Operating OfficerWaterMark Medical
Telephone:	877-710-6999
Establishment Registration #:	3008208119
Submission Contact:	Michael J. Leigh, consultant12715 Falcon DriveBrookfield, Wisconsin 53005Ph: (262) 957-6797
Trade Name:	Connected Care Mobile Application
Predicate Device:	Honeywell HomMed Genesis DM, K101242
Common Name:	Patient Vital Signs Monitor
Classification Name:

510(k) Summary for Watermark Medical Mobile Application

RegulationNumber	ProductCode	Classification Name	DeviceClass
870.2910	DRG	Transmitters And Receivers, PhysiologicalSignal, Radiofrequency	II
Medical device product codes also supported by Mobile Application by means ofseparate medical devices
870.1130	DXN	Noninvasive Blood Pressure MeasurementSystem	II
880.2700	FRI	Patient Weight Scale	I
870.2700	DQA	Oximeter	II
862.1345	NBW	Glucose Test System	II

Device Description:

. Scale
Glucose meter
NiBP .
. SPO2

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Intended Use:

The Watermark Medical Mobile Application is intended for personal use. The Mobile Application collects vital signs data (including noninvasive blood pressure, pulse rate, weight and other data from optional add-on devices) then can transmit the data to a central database via a communication network. Use of the system allows retrospective review of certain physiological functions. The Mobile Application is intended for use with adult and pediatric patients over twelve years of age.

Performance Data:

The software validation results demonstrated that the Mobile Application was in compliance with the guidelines and standards referenced in the FDA reviewer's guides and that it performed within its specifications and functional requirements for software.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of FDA regarding medical device software.

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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 & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

JUL 1 8 2012

Watermark Medical, Inc. c/o Mr. Michael J. Leigh Consultant 12715 Falcon Drive Brookfield, WI 53005

Re: K120325

Trade/Device Name: · Connected Care Mobile Application Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitters and Receivers Regulatory Class: Class II (two) Product Codes: DRG, DXN, FRI, DQA, NBW Dated: April 30, 2012 Received: June 27, 2012

Dear Mr. Leigh:

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.

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 - Watermark Medical, Inc., c/o Mr. Michael J. Leigh

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/CDRH0ffices/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.

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): Kxxxx K I2 6325

Watermark Medical Connected Care Mobile Application Device Name:

Indications For Use:

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

Over-The-Counter Use (21 CFR 807 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

Page 1 of 1

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).