Clinical Application's intended use is to retrospectively receive, display and store monitored vital signs parameters and related data. Additionally, it can send configuration information to Watermark home monitoring devices. Watermark devices include the Connected Care Mobile Application and MiPal. The configuration information may include a patient's vitals collection schedule and parameters to be collected. The Clinical Application displays the data and system alerts for review and interpretation by a healthcare professional. The Clinical Application is not intended for emergency use or real-time monitoring.

Device Description

The Connected Care Clinical Application is a cloud based, web software system. It is accessed from commercially available PC systems with a web browser and minimum performance specifications consistent with typical PC hardware and equipment specifications. The Clinical Application accepts data from Watermark Patient Monitors.

The Connected Care Clinical Application is a medical device data system that receives, stores, and displays data received from Watermark home monitoring devices. Additionally, it can send configuration information to Watermark home monitoring devices. Watermark devices include the Mobile Application and MiPal. The configuration information may include a patient's vitals collection schedule and parameters to be collected.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Watermark Medical Connected Care Clinical Application (K120320):

The provided document describes a Medical Device Data System (MDDS). For such systems, the "acceptance criteria" are not typically framed in terms of clinical performance metrics like sensitivity, specificity, or accuracy compared to a ground truth label. Instead, the acceptance criteria revolve around software validation and functional requirements. The "study" that proves the device meets these criteria is the software validation process itself.

Based on the provided text, here's the information categorized:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied from text)	Reported Device Performance
Functional Requirements: - Receives vital signs parameters and related data - Stores vital signs parameters and related data - Displays vital signs parameters and related data - Sends configuration information to Watermark home monitoring devices (Mobile Application and MiPal) - Configuration information includes patient vitals collection schedule and parameters - Displays data and system alerts for review and interpretation by a healthcare professional	The software validation results demonstrated that the Clinical Application performed within its specifications and functional requirements for software.
Compliance with Guidelines and Standards: - Adherence to FDA reviewer's guides for medical device software	The software validation results demonstrated that the Clinical Application was in compliance with the guidelines and standards referenced in the FDA reviewer's guides.
Intended Use: - For retrospective review - Not for emergency - Not for real-time monitoring	The device's performance aligned with its stated intended use for retrospectively receiving, displaying, and storing monitored vital signs and related data for review and interpretation by a healthcare professional, and sending configuration information.

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

Test Set Sample Size: Not explicitly stated. The document refers to "software validation results," which implies a series of tests, but not a specific sample size of medical cases or data points.
Data Provenance: Not explicitly stated. Given the device's function (receiving data from Watermark home monitoring devices), the data would originate from these devices. The document does not specify country of origin or whether the data used for validation was retrospective or 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 applicable in the traditional sense for this type of device (MDDS). The "ground truth" for an MDDS primarily relates to whether the software correctly receives, stores, displays, and transmits data as per its specifications, not whether it correctly labels or diagnoses a medical condition. The validation would involve comparing the displayed data against the received data, and the transmitted configuration against the entered configuration. This typically involves software testers or quality assurance personnel verifying data integrity and functionality.

4. Adjudication method for the test set

Not applicable in the traditional sense. Since the validation is software-centric (data integrity and functionality), adjudication by medical experts for discrepant interpretations wouldn't be relevant. Software testing typically involves predefined test cases with expected outcomes. Any discrepancies would be bugs to be fixed and re-tested, not adjudicated.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices that assist in diagnosis or interpretation (e.g., AI for radiology). The Connected Care Clinical Application is an MDDS that primarily handles data management and display; it does not involve AI for interpretation or diagnosis. Therefore, there is no effect size related to human reader improvement with or without AI.

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

Yes, in essence, the software validation for functional correctness is a standalone evaluation. The device itself is "software only" in its function, receiving and displaying data. Its performance is judged on whether it correctly executes its specified functions (receiving, storing, displaying, transmitting data) independent of human interpretation of clinical outcomes. The "algorithm" here refers to the software's logic for handling data.

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

The "ground truth" for this MDDS would be the expected output or behavior of the software, based on its design specifications. This means:
- Data Integrity: The data received matches the data sent from the monitoring devices.
- Data Storage: The stored data accurately reflects the received data.
- Data Display: The displayed data accurately reflects the stored data according to display specifications.
- Configuration Transmission: The configuration sent to the devices matches the configuration entered into the system.
This ground truth is established by software requirements specifications and design documents, against which the validated system's performance is measured.

8. The sample size for the training set

Not applicable. This device is an MDDS and does not employ machine learning or AI models that require a training set. Its functionality is based on deterministic software logic, not on learning from data.

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

Not applicable, as there is no training set for this device.

Summary

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K120320

Submitter:	Watermark Medical		AUG 14 2012
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 Clinical Application
Predicate Device:	Honeywell HomMed Central Station, K072272
Common Name:	Patient Vital Signs Monitor Viewing Station
Classification Name:
	Regulation	Product	Classification Name	Device

510(k) Summary for Watermark Medical Connected Care Clinical Application

Regulation Number	Product Code	Classification Name	Device Class
870.1130	DXN	System, Measurement, Blood-Pressure,Non-Invasive	II
Medical Device product codes also supported by Clinical Application bymeans of separate medical devices
880.2700	FRI	Patient Weight Scale	I
870.270	DQA	Oximeter	II
862.1345	NBW	Glucose Test System	II

Device Description:

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Intended Use:

Clinical Application's intended use is to retrospectively receive, display and store monitored vital signs parameters and related data. The Web Application displays the data and system alerts for review and interpretation by a healthcare professional. The Web Application is not intended for emergency use or real-time monitoring.

Performance Data:

The software validation results demonstrated that the Clinical Application was in compliance with the guidelines and standards referenced in the FDA reviewer's quides 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 1 4 2012

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

Re: K120320

Trade/Device Names: Watermark Connected Care Clinical Application Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN, FRI, DQA, NBW Dated: April 27, 2012 Received: July 18, 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, Trug 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. Michael J. Leigh

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 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,

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): K120320

Watermark Medical Connected Care Clinical Application Device Name:

Indications For Use:

Federal (USA) law restricts this device to sale by or on the order of a physician.

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-C
Division of Cardiovascular Devices

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).