The Unity Network® IS Patient Viewer is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the Unity Network® IS Patient Viewer is to provide a remote view of physiological parameter data on adult, pediatric and neonatal patients within a hospital or facility providing patient care. The Unity Network® IS Patient Viewer is NOT intended for primary monitoring but is to be used in conjunction with the bedside monitor.

The Unity Network® IS Patient Viewer is intended to provide near-real-time physiological data and graphical trends for all monitors connected to the Unity Network to secure nurse and physician personal computers (local and remote).

Device Description

The Unity Network® IS Patient Viewer provides remote access to waveform, parameter data and trend data at a Web browser on a standard personal computer. The server resides on the hospital's intranet and remote access is gained through secured access to the hospital's intranet.

The data relayed from the patient monitors over the Unity® MC network includes patient name, unit and bed name, parameter data, and waveform data monitored by the bedside monitors. The user can view up to nine waveforms from the Unity® MC network as well as the parameter information in near real-time. Neither alarm messages nor parameter status messages are displayed.

The Unity Network® IS Patient Viewer system provides a secondary view of patient information, and is NOT a patient monitoring device. The clinician is instructed to always reference the primary bedside monitor before making any patient care decisions. In the event that data is not available via the Unity Network® IS Patient Viewer, the clinician is instructed to obtain the data from the primary bedside monitor.

AI/ML Overview

The provided text is a 510(k) summary for the GE Medical Systems Information Technologies Unity Network® IS Patient Viewer. It details the device's intended use and the testing performed to demonstrate its safety and effectiveness. However, it does not contain specific acceptance criteria, reported device performance metrics in a table, or a detailed study description with the information requested.

The document primarily focuses on establishing substantial equivalence to a predicate device (K020661 Unity Network® IS Patient Viewer) and lists general quality assurance measures applied during development.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is missing:

1. A table of acceptance criteria and the reported device performance

Missing. The document states, "The results of these measurements demonstrated that the Unity Network® IS Patient Viewer is as safe, as effective, and perform as well as the predicate device." However, it does not provide any specific quantitative acceptance criteria or reported performance metrics in a table. The test summary lists various types of testing (Risk Analysis, Requirements Reviews, Design Reviews, Unit level testing, Integration testing, Final acceptance testing, Performance testing, Safety testing, Environmental testing) but doesn't elaborate on the criteria used or the outcomes of these tests in a measurable way with respect to the device's actual performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing. The document does not specify any sample sizes for a test set, nor does it provide information about data provenance (country of origin, retrospective/prospective). The "Test Summary" section lists general types of testing rather than a specific clinical or performance evaluation study with defined test sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing. Since there is no detailed description of a specific test set or a study involving human experts for ground truth establishment, this information is not present. The device is a patient data viewer, not an AI diagnostic tool that typically requires expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing. As no specific "test set" requiring expert adjudication is described, this information is not applicable and therefore not present.

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 / Missing. The device is described as a "secondary view of patient information" and "NOT a patient monitoring device," intended to provide a remote view of physiological parameter data. It is not an AI-assisted diagnostic tool designed to improve human reader performance. Therefore, an MRMC comparative effectiveness study in the context of AI assistance is not relevant to this device's stated function.

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

Not applicable / Missing. The device is a system for displaying physiological data, not an algorithm performing a standalone diagnostic or analytical function. Its purpose is to provide "near-real-time physiological data and graphical trends" to human users. The concept of "standalone performance" for an algorithm in this context does not directly apply. Its performance is implicitly tied to its ability to accurately relay data from patient monitors.

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

Missing. The concept of "ground truth" as typically applied to diagnostic or AI devices (e.g., expert consensus on images, pathology results) isn't explicitly addressed here. The device's function is to display data from existing bedside monitors. Therefore, the "ground truth" would implicitly be the data generated by the primary bedside monitors, and the device's performance would be measured by its accuracy in reflecting that data, rather than generating its own ground truth.

8. The sample size for the training set

Not applicable / Missing. The document describes a "Computer, Information Network Server" that relays data. It does not appear to be an AI/machine learning device that would have a "training set" in the conventional sense. The testing performed (Risk Analysis, Requirements Reviews, etc.) relates to software and system validation, not machine learning model training.

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

Not applicable / Missing. Given that this is not an AI/machine learning device, the concept of a "training set" and establishing "ground truth" for it does not apply.

In summary: The provided 510(k) summary focuses on establishing substantial equivalence based on functional equivalence and general quality assurance measures for a patient data viewer. It does not contain the detailed performance metrics, study designs, sample sizes, or ground truth information typical for diagnostic devices or AI-powered systems. The conclusion states that the device is "as safe, as effective, and perform[s] as well as the predicate device," implying that the testing confirmed it met its functional requirements and safety standards without necessarily providing quantitative performance data.

Summary

{0}------------------------------------------------

AUG - 6 2003

Section 2 Summary and Certification

510(k) Summary of Safety and Effectiveness

Date:	July 29, 2003
Submitter:	GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA
Contact Person:	Diana M. ThorsonRegulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: (714) 247-4135Fax: (414) 918-8114
Device: Trade Name:	Unity Network® IS Patient Viewer
Common/Usual Name:	Computer, Information Network Server
Classification Names:	21 CFR 870.2300 System, Network and Communication, Physiological
Predicate Devices:	K020661 Unity Network® IS Patient Viewer
Device Description:	The Unity Network® IS Patient Viewer provides remote access towaveform, parameter data and trend data at a Web browser on astandard personal computer. The server resides on the hospital'sintranet and remote access is gained through secured access to thehospital's intranet.The data relayed from the patient monitors over the Unity® MC networkincludes patient name, unit and bed name, parameter data, andwaveform data monitored by the bedside monitors. The user can viewup to nine waveforms from the Unity® MC network as well as theparameter information in near real-time. Neither alarm messages norparameter status messages are displayed.The Unity Network® IS Patient Viewer system provides a secondaryview of patient information, and is NOT a patient monitoring device.The clinician is instructed to always reference the primary bedsidemonitor before making any patient care decisions. In the event thatdata is not available via the Unity Network® IS Patient Viewer, theclinician is instructed to obtain the data from the primary bedsidemonitor.

{1}------------------------------------------------

Intended Use: The Unity Network® IS Patient Viewer is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the Unity Network® IS Patient Viewer is to provide a remote view of physiological parameter data on adult, pediatric and neonatal patients within a hospital or facility providing patient care. The Unity Network® IS Patient Viewer is NOT intended for primary monitoring but is to be used in conjunction with the bedside monitor. -

The Unity Network® IS Patient Viewer is intended to provide near-realtime physiological data and graphical trends for all monitors connected to the Unity Network to secure nurse and physician personal computers (local and remote).

The Unity Network® IS Patient Viewer system employs the same Technology: functional technology as the predicate device. Changes made reflect the recent advancements in wireless technology, offering improved performance and mobility.

Test Summary:

The Unity Network® IS Patient Viewer complies with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures were applied to the development of the Unity Network® IS Patient Viewer:

Risk Analysis .
Requirements Reviews .
Design Reviews
Testing on unit level (Module verification) .
Integration testing (System verification) .
Final acceptance testing (Validation) ●
Performance testing
Safety testing .
Environmental testing .

Conclusion:

The results of these measurements demonstrated that the Unity Network® IS Patient Viewer is as safe, as effective, and perform as well as the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle. The logo is rendered in black and white.

AUG - 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems Information Technologies Ms. Diane M. Thorson Corporate Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223

Re: K032346

Trade Name: Unity Network® IS Patient Viewer Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MSX Dated: July 29, 2003 Received: July 30, 2003

Dear Ms. Thorson:

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 10 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. Iisting 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 such 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

{3}------------------------------------------------

Page 2 - Ms. Diane M. Thorson

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page 1 of 1

510(k) Number (if known):

510(k) filed on July 29, 2003

Device Name:

Unity Network® IS Patient Viewer

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801:109)

Over-The-Counter Use

(Optional Format 1-2-96)

Nole Te

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number

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).