The Decisio Health Patient Dashboard is a decision support device indicated for aggregating, displaying, and managing physiologic and other patient information. This information is generated by third party medical devices and patient information systems. The device performs automated calculations on patient data collected by third party devices based on approved clinical protocols at patient care facilities.

The Decisio Health Patient Dashboard is intended for use by clinicians in healthcare facilities.

Device Description

The Decisio Health Patient Dashboard ("Patient Dashboard") is a data aggregation and visualization software device. The Patient Dashboard is designed to display patient information, facility specific care protocols, and visual cues to care providers on a single display device. The Patient Dashboard is configured to receive patient data through the facility's Electronic Medical Record system and display information to the user on a patient monitor, computer, or a mobile device. Data received through the EMR includes input from various sources within the hospital, including manually entered data into the EMR (e.g., laboratory data), vital signs monitors, ventilators, IV pumps, and Foley catheter devices. The data the Patient Dashboard receives are then stored, filtered, and displayed through the Patient Dashboard web browser application. The Patient Dashboard is customized to individual facility's care as it is programmed with the facility's treatment protocols, which dictate the information that is displayed relative to those protocols. The device performs automated calculations on patient data collected by third party devices based on approved clinical protocols at patient care facilities.

AI/ML Overview

This document (K142106) describes the Decisio Health Patient Dashboard, a decision support device designed to aggregate, display, and manage patient information from third-party medical devices and information systems.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific acceptance criteria (e.g., specific accuracy thresholds for calculations, or display fidelity metrics) with corresponding numerical device performance results as one might expect for a diagnostic or classification device.

However, based on the Testing in Support of Substantial Equivalence Determination section, the general acceptance criteria can be inferred as:

Acceptance Criteria Category	Description	Reported Device Performance
Functional Performance	Device performs as intended per its specifications, including: - Receiving data from the EMR. - Processing patient data according to a facility protocol. - Displaying the data as expected. - Performing automated calculations on patient data based on approved clinical protocols.	"Unit, integration, and system level testing demonstrated that the Patient Dashboard meets its specifications, including receiving data from the EMR, processing patient data according to a facility protocol, and displaying the data as expected." "Performance testing verified that the device performs as intended." (No specific numerical metrics are provided for these performance aspects in the summary.)
Usability/ Human Factors	The device design meets its intended use, and the user can interpret the displayed information as intended.	"Additionally, a human factors and usability study has been performed with the Patient Dashboard... The results of the study confirmed that the Patient Dashboard design meets its intended use and the user can interpret the displayed information as intended." (No specific quantitative usability metrics or error rates are provided, only a general confirmation of meeting the goal.)
Safety & Effectiveness	Differences in technological characteristics between the Patient Dashboard and predicate devices do not raise new issues of safety or effectiveness.	"The differences in technological characteristics between the Patient Dashboard and the predicate devices do not raise new issues of safety or effectiveness." and "The differences in technological characteristics have been analyzed and addressed through software performance testing, and human factors and usability testing." (This is a qualitative statement of equivalence, not a direct performance metric.)

Note: This submission is for a Class II regulatory clearance (510(k)), which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than independently proving safety and effectiveness through extensive clinical trials like a PMA. Therefore, the level of detail on specific performance metrics might be less extensive than for some other device types.

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

Test Set Sample Size:
- Functional Testing (Software Performance Testing): The document states "Unit, integration, and system level testing." It does not specify a numerical sample size for data points or test cases used in this testing.
- Human Factors and Usability Study: 45 clinicians were involved.
Data Provenance: The document does not specify the country of origin for the data used in functional testing. For the human factors study, it implies the clinicians are from "healthcare facilities" where the device is intended for use, but no specific geographic location is mentioned. The study is prospective in nature, as it was conducted specifically for the device submission.

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

Functional Testing: The document does not mention external experts establishing ground truth for functional software testing. This type of testing typically relies on predefined specifications and expected outputs generated by developers or quality assurance engineers.
Human Factors and Usability Study: The "clinicians" (45 of them) served as the "experts" or primary evaluators in this study by providing feedback on the device's design and interpretability. Their specific qualifications (e.g., tenure, specialty) are not detailed beyond "clinicians." The "ground truth" for usability is their ability to correctly interpret displayed information and interact with the device as intended.

4. Adjudication Method for the Test Set

Functional Testing: Not applicable in the context of expert adjudication. Software testing typically involves verifying outputs against expected results defined by specifications.
Human Factors and Usability Study: The document does not describe an explicit adjudication method (like 2+1 or 3+1 consensus). The "results of the study confirmed" suggests a summary of observations and feedback from the 45 clinicians led to the conclusion about the design's suitability and interpretability. It's likely a qualitative assessment or a design qualification activity rather than a ground truth establishment by external adjudicators for patient data.

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

No, a MRMC comparative effectiveness study was not explicitly done or reported. The human factors study involved multiple clinicians but was focused on usability and interpretability of the device's output, not on comparing their performance with and without the AI assistance in a diagnostic or clinical decision-making context with specific clinical outcomes. The device is a "decision support device" that aggregates and displays information; it's not described as an AI that provides specific diagnostic interpretations that would typically warrant a full MRMC study.
Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable, as an MRMC study comparing human performance with and without the device's assistance was not conducted or reported.

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

Yes, a form of standalone performance was assessed through "Unit, integration, and system level testing." This software performance testing directly addressed how the algorithm (the "Patient Dashboard" software) "receives data from the EMR, processes patient data according to a facility protocol, and displays the data as expected" and "performs automated calculations." This specifically describes the algorithm's functional performance in isolation of direct human interpretative decision-making during the test itself (though it's designed for human use). The output of these tests would be objective verification against specifications.

7. Type of Ground Truth Used

Functional Testing (Software Performance): The ground truth for this testing would be the predefined specifications for data reception, processing rules (facility protocols), calculation outputs, and display requirements. This implies the ground truth is established by internal engineering and quality assurance standards.
Human Factors and Usability Study: The "ground truth" (or success criteria) for this study was the intended use and user interpretability, as confirmed by the clinicians. This is a form of expert consensus/feedback on usability and functional clarity, rather than a clinical ground truth like pathology or direct outcomes data.

8. Sample Size for the Training Set

The document does not mention a training set sample size. This device is described as a "data aggregation and visualization software device" that "performs automated calculations on patient data collected by third party devices based on approved clinical protocols." This suggests it's primarily a rule-based system or a display system for pre-existing calculations/protocols, rather than a machine learning model that requires a "training set" in the conventional sense. If there are any "automated calculations," they are based on "approved clinical protocols," implying rules configured by clinical experts rather than learned from a dataset.

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

As a training set is not explicitly mentioned or implied for a machine learning model, this question is not applicable. The device's "automated calculations" are stated to be based on "approved clinical protocols at patient care facilities," meaning these protocols themselves serve as the 'ground truth' or rules governing the calculations, established by clinical expertise at the local facility level, not derived from a training dataset.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

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

January 16, 2015

Decisio Health, Inc. c/o Ronald Warren Regulatory Consultant Experien Group. LLC 755 N. Mathilda Avenue, Suite 100 Sunnyvale, California 94085

Re: K142106

Trade/Device Name: Decisio Health Patient Dashboard Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: December 18, 2014 Received: December 19, 2014

Dear Ronald Warren,

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 device

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related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (OS) 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 yours,

Melissa A. Torres -S

For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K142106

Device Name Decisio Health Patient Dashboard

Indications for Use (Describe)

The Decisio Health Patient Dashboard is a decision support device indicated for aggregating, displaying, and managing physiologic and other patient information is generated by third party medical devices and patient information systems. The device performs automated calculations on patient data collected by third party devices based on approved clinical protocols at patient care facilities.

The Decisio Health Patient Dashboard is intended for use by clinicians in healthcare facilities.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510(k) Notification K142106

GENERAL INFORMATION

Applicant:

Decisio Health, Inc. 6500 Main St, Suite 1030, Houston, TX 77030 U.S.A. Phone: 713-252-8124

Contact Person:

Ronald S. Warren Regulatory Consultant for Decisio Health, Inc. Experien Group, LLC 755 N. Mathilda Ave, Suite 100 Sunnyvale, CA 94085 U.S.A. Phone: 1-408-505-3926 FAX: 1-408-400-0865

Date Prepared: January 8, 2015

DEVICE INFORMATION

Trade Name:

Decisio Health Patient Dashboard

Generic/Common Name:

Physiological Patient Monitor (without arrhythmia detection or alarms)

Classification:

Class II, 21 CFR$870.2300, Cardiac monitor (including cardiotachometer and rate alarm)

Product Code:

MWI, Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms)

PREDICATE DEVICES

The following predicate devices have been selected:

AirStrip Remote Patient Monitoring RPM Remote Data Viewing software, AirStrip Technologies LP. (K100133)
. AlertWatch: OR, AlertWatch LLC (K130401)

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510(k) SUMMARY

INDICATIONS FOR USE

The Decisio Health Patient Dashboard is intended for use by clinicians in healthcare facilities.

PRODUCT DESCRIPTION

SUBSTANTIAL EQUIVALENCE

The indications for use for the predicate devices are substantially equivalent to the proposed indications for use for the Patient Dashboard. Any differences in the technological characteristics between the devices do not raise new issues of safety or effectiveness. Thus, the Patient Dashboard is substantially equivalent to the predicate devices.

TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary testing was conducted on the Patient Dashboard to support a determination of substantial equivalence to the predicate devices. Performance testing was conducted on the Patient Dashboard to ensure that the device performs as intended per its specifications. Unit, integration, and system level testing demonstrated that the Patient Dashboard meets its specifications, including receiving data from the EMR, processing patient data according to a facility protocol, and displaying the data as expected.

Additionally, a human factors and usability study has been performed with the Patient Dashboard. The study involved 45 clinicians, who are the intended users of the Patient Dashboard. The results of the study confirmed that the Patient Dashboard design meets its intended use and the user can interpret the displayed information as intended.

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510(k) SUMMARY

Therefore, performance testing verified that the device performs as intended, its design meets its intended use, and that the differences in technological characteristics between the Patient Dashboard and the predicate devices do not raise new issues of safety or effectiveness.

CONCLUSION

The Patient Dashboard has the same intended use and similar technological characteristics as do the predicate devices. The differences in technological characteristics have been analyzed and addressed through software performance testing, and human factors and usability testing. As such, the Patient Dashboard is substantially equivalent to the predicate devices.

SUMMARY

The Decisio Health Patient Dashboard is substantially equivalent to the predicate devices.

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).