The Unity Network ID is indicated for use in data collection and clinical information management through networks with independent bedside devices. The Unity Network ID is not intended for monitoring purposes, nor is the Unity Network ID intended to control any of the ctinical devices (independent bedside devices/ information systems) it is connected to.

Device Description

The Unity Network ID system communicates patient data from sources other than GE Medical Systems Information Technologies, Inc. equipment to a clinical information system, central station, and/or GE Medical Systems Information Technologies Inc. patient monitors. The Unity Network ID acquires digital data from eight serial ports, converts the data to Unity Network protocols, and transmits the data over the monitoring network to a Unity Network device such as a patient monitor, clinical information system or central station.

AI/ML Overview

The provided text describes the Unity Network ID, a physiological patient monitor, and its 510(k) submission. However, it does not contain the specific details required to answer all parts of your request, particularly regarding acceptance criteria, performance data, sample sizes, expert ground truth establishment, or multi-reader multi-case studies.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K071982 Unity Network ID) through a design modification. The "Test Summary" section lists general quality assurance measures applied during development, but not specific acceptance criteria or quantitative performance results.

Here's what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The document states the device "complies with the voluntary standards as detailed in Section 9.2 - Specific Standards and Guidance of this submission." However, the specific standards and their associated acceptance criteria are not included in the provided text.	The "Test Summary" and "Conclusion" sections state that "The results of these measurements demonstrated that the Unity Network ID is as safe, as effective, and performs as well as the predicate device." However, no quantitative performance metrics are provided. The tests mentioned are: - Risk Analysis - Requirements Reviews - Design Reviews - Subsystem Verification - Integration testing (System verification) - Final acceptance testing (Validation) - Performance testing - Safety testing - Environmental testing

Acceptance Criteria

Reported Device Performance

Not explicitly stated in the document. The document states the device "complies with the voluntary standards as detailed in Section 9.2 - Specific Standards and Guidance of this submission." However, the specific standards and their associated acceptance criteria are not included in the provided text.

The "Test Summary" and "Conclusion" sections state that "The results of these measurements demonstrated that the Unity Network ID is as safe, as effective, and performs as well as the predicate device." However, no quantitative performance metrics are provided. The tests mentioned are: - Risk Analysis - Requirements Reviews - Design Reviews - Subsystem Verification - Integration testing (System verification) - Final acceptance testing (Validation) - Performance testing - Safety testing - Environmental testing

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "measurements" and "testing" but does not provide any information on the size of the test set (e.g., number of patients, data points, or test cases).
- Data Provenance: Not specified. There is no information regarding the country of origin of the data or whether it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document does not describe the establishment of a "ground truth" using human experts for the test set. The evaluation seems to be based on engineering and validation testing against internal standards and the predicate device's functionality.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. Since there's no mention of expert-based ground truth or performance assessment involving human interpretation, an adjudication method is not described.
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. The document makes no mention of an MRMC study. The device is a "Unity Network ID" system that communicates patient data; it is not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device itself appears to be a "standalone" system in the sense that it processes data without direct human-in-the-loop diagnostic interpretation. The document describes it as acquiring, converting, and transmitting data. The "performance testing" and "final acceptance testing" would assess its functional performance in this standalone capacity, but no detailed results for this are provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly defined in the context of expert-based ground truth. The "ground truth" for this device's validation appears to be its ability to correctly acquire, convert, and transmit digital data according to specifications and in a manner "as safe, as effective, and performs as well as the predicate device." This would typically be assessed through engineering verification and validation against functional requirements and possibly relevant industry standards, rather than clinical outcomes or expert consensus on medical findings.
The sample size for the training set:
- Not applicable/Not specified. The Unity Network ID primarily acts as a data communication and management system. It's not described as an AI/ML device that requires a "training set" in the conventional sense for learning patterns or making diagnostic predictions. Its development involves "Risk Analysis," "Requirements Reviews," "Design Reviews," etc., which are typical for traditional software and hardware development, not machine learning model training.
How the ground truth for the training set was established:
- Not applicable/Not specified, as there is no mention of a training set for an AI/ML model.

Summary

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DEC 1: 7 2010

510(k) Summary of Safety and Effectiveness Date: November 18, 2010 Submitter: GE Medical Systems Information Technologies, Inc. 8200 West Tower Avenue USA Milwaukee, WI 53223 Contact Person: Robert Casarsa Regulatory Affairs Leader GE Medical Systems Information Technologies, Inc. Phone: (414) 362-3063 Fax: (414) 362-2585 E-mail: robert.casarsa@ge.com Secondary Contact Robin Fitzgerald Person: Regulatory Affairs Leader GE Medical Systems Information Technologies, Inc. Phone: (414) 362-3176 Fax: (414) 362-2585 E-mail: robin.fitzgerald@ge.com Device Trade Name: Unity Network ID Common /Usual Name: Physiological Patient Monitor Classification Names: 21 CFR 870.2300 Monitor, Physiological, Patient (without arrhythmia detection or alarms) Predicate Device: K071982 Unity Network ID Device Description: The Unity Network ID system communicates patient data from sources other than GE Medical Systems Information Technologies, Inc. equipment to a clinical information system, central station, and/or GE Medical Systems Information Technologies Inc. patient monitors. The Unity Network ID acquires digital data from eight serial ports, converts the data to Unity Network protocols, and transmits the data over the monitoring network to a Unity Network device such as a patient monitor, clinical information system or central station. The Unity Network ID is indicated for use in data collection and Intended Use: information management through networks with clinical The Unity Network ID is not independent bedside devices.

intended for monitoring purposes, nor is the Unity Network ID intended to control any of the clinical devices (independent

bedside devices/ information systems) it is connected to.

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Technology:

ﺮ

The Unity Network ID employs the same functional technology as the predicate device.

Test Summary:

The subject of this 510(k) is a design modification for the Unity Network ID. The Unity Network ID complies with the voluntary standards as detailed in Section 9.2 - Specific Standards and Guidance of this submission. The following quality assurance measures were applied to the development of the Unity Network ID:

Risk Analysis .
. Requirements Reviews
. Design Reviews
. Subsystem 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 ID is as safe, as effective, and performs as well as the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

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

DEC 1: 7 2010

GE Medical Systems Information Technologies, Inc. c/o Mr. Robert L. Casarsa Regulatory Affairs Leader 8200 West Tower Avenue Milwaukee, WI 53223

Re: K103432

Trade/Device Name: Unity Network ID V6 Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: November 22, 2010 Received: November 29, 2010

Dear Mr. Casarsa:

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 commence 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.

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Page 2 – Mr. Robert L. Casarsa

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/ucm11.5809.html 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.

Sincerelv vours.

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): Klo 343 Z

Device Name: Unity Network ID

Indications for Use:

Prescription Use _ Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 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

§ 870.2300 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).