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The GE Datex-Ohmeda S/5™ Network and Central transfers information between networked Datex-Ohmeda devices in the Datex-Ohmeda monitor network. It also allows information transfer between several iCentrals. Within one Datex-Ohmeda monitor network it allows a networked device to display, store, print and otherwise process information received from other networked devices.

The GE Datex-Ohmeda S/5™ iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other networked devices in GE Datex-Ohmeda monitor network. Network connections consist of hardwired network cables and/or Wireless LAN (WLAN) connections. Furthermore, it coordinates the transfer of information between devices in the GE Datex-Ohmeda S/5TM Network as well as between the GE Datex-Ohmeda Network and Hospital Information Systems (HIS).

The GE Datex-Ohmeda S/5™ iCentral can be used for remote monitor management, storing, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other networked devices.

The GE Datex-Ohmeda S/5™ Network will be used for patients in the hospital and it is meant for continuous use.

The device is for use by qualified personnel only.

The GE Datex-Ohmeda S/5 Network (also referred as D-O Network in the related documentation) is a system, which consists of networked devices (which have separate 510(k) clearance) and the actual networking hardware. The networked devices are Datex-Ohmeda products containing a network adapter for physical access to the D-O Network as well as software modules supporting network access. Examples of currently available networked devices are:

• 1 . Datex-Ohmeda S/5 Anesthesia Monitor
• 2. Datex-Ohmeda S/5 Compact Anesthesia Monitor
• 3. Datex-Ohmeda S/5 Critical Care Monitor
• 4. Datex-Ohmeda S/5 Compact Critical Carc Monitor
• 5. Datex-Ohmeda S/5 Light Monitor
• Datex-Ohmeda S/5 Cardiocap 5 Monitor 6.
• 7. Datex-Ohmeda S/5 WebViewcr
• 8. Datex-Ohmeda S/5 PocketViewer/WebViewer with L-WEB03
• ੇ GE Datex-Ohmeda S/5 Network and iCentral, included in this 510(k)

The DeioRecorder for Anesthesia (formerly named as Datex-Ohmeda AS/3 Record Keeper) is also related to the D-O Network as an application using the services provided by the D-O Network. No changes must be made to the GE Datex-Ohmeda S/5 Network and iCentral itself due to a new type of networked device. As a consequence, adding new types of Datex-Ohmeda devices to GE Datex-Ohmeda Network does not in any way affect the safety and effectivencss of GE Datex-Ohmeda Network or iCentral, if the devices are using the same protocol and the same design principles are followed as in the currently networked Datex-Ohmeda devices. In such cases, no new 510(k) application will be submitted to update the list of networked devices. The GE Datex-Ohmeda S/5 iCentral (also referred to as D-O iCentral in the rclated documentation) is the primary maintainer of communication between other networked devices and is, thus, an essential part of the network. The structure and functionality of the revised network corresponds to the structure and functionality of the substantially equivalent predicate device Datex-Ohmeda Network and Central '03 (510(k) number: K033281).

The GE Datex-Ohmeda Network will be used for real-time communication between devices, for record keeping and for data management in a hospital. Practical examples of currently available features are:

• Transmission and display of measured values and alarms in the GE Datex-Ohmeda S/5 iCcntral screen (central monitoring) and on the screen of another networked monitor (monitor-to-monitor communication).
• • Anesthesia record keeping.
• • Storing and transferring of trend and record keeping data in the network. When the patient is moved from one monitor to another, the data can be transferred with the patient. This feature includes also transferring data from/to an external system (HIS, laboratory, etc.) to/from GE Datex-Ohmeda S/5 Network.
• • Storing and displaying selected waveforms over the whole patient case (Full Disclosure)
• • Printing of anesthesia records, ICU reports, trend printouts, spirometry loop printouts. waveform snapshot printouts, etc.

The actual networking hardware consists of cabling, patch panels, racks, connectors, repeaters, access points with antennas etc. The networking hardware is similar to the networking hardware of the substantially equivalent predicate device Datex-Ohmeda Network and Central '03 (510(k) number: K033281).

Modifications to the predicate device Datex-Ohmeda Network and iCentral '03 K033281

• Navigating PDF printouts based on patient names. 1.
• 2. Change of the display option D-LCC19.
• 3. Revision change of the display option D-CFLT17.
• 4. Using the latest display driver for the Matrox G450 display card.
• 5. A new PC for the S/5 iCentral network computer.
• Distributed patient data over several networked S/5 iCentrals. (). 7. Limited iCentral functionality with iCentral Client product.
• 8. Localization to 11 languages.
• ্ Compatibility with Symantec virus scanner
• 10. Improved Full Disclosure printout.
• 】 1 . Possibility to generate an event history printout.
• 12. Improved Multi View patient sector setup.
• I 3. Possibility to define the defaults to use in a patient sector.
• 14 Support for Datex-Ohmeda S/5 FM monitor.
• ા રે . Improved time synchronization.

This FDA submission (K042771) describes a medical device, the GE Datex-Ohmeda S/5 Network and iCentral '03, Sales Revision 3.3. However, this document does not contain a study that proves the device meets specific acceptance criteria in terms of clinical performance or accuracy for diagnostic purposes. Instead, it is a Premarket Notification 510(k) Summary focused on demonstrating substantial equivalence to a previously cleared predicate device (Datex-Ohmeda S/5 Network and iCentral '03, K033281).

The "acceptance criteria" discussed in this document relate to compliance with regulatory standards and the device performing its intended functions as a network and central station for physiological monitors, similar to its predicate.

Here's an analysis based on the provided text, addressing your points:

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

Since this is a 510(k) for substantial equivalence of a network and central station, the "performance" is primarily about compliance with standards and successful new functionalities rather than diagnostic accuracy metrics.

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

• No specific sample size for a test set is mentioned in the context of clinical performance or diagnostic accuracy, as this is not a diagnostic device with performance claims.
• The "testing" mentioned is primarily nonclinical testing for compliance with safety standards and verification of new functionalities. This would generally involve internal testing, not a clinical "test set" with patient data.
• Data provenance is not applicable in the same way it would be for a clinical trial. The device manufacturer (Datex-Ohmeda, an affiliate of GE) is based in Needham, MA, USA, but testing would have occurred internally or at certified labs.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This document does not describe a study involving expert-established ground truth for a test set, as it's not a diagnostic AI/ML device but rather a network and central station for existing physiological monitors. The "experts" involved would likely be engineers, quality assurance personnel, and regulatory specialists validating the device's adherence to technical standards and specifications.

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

• Not applicable. No clinical test set or adjudication method is described.

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. This type of study is completely irrelevant to the device described (a clinical network and central station).

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

• Not applicable. This device is a system for managing and displaying data from other medical devices, not a standalone diagnostic algorithm. Its performance is evaluated in terms of its networking capabilities, data integrity, and compliance with standards.

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

• Not applicable. For this type of device, "ground truth" would relate to the correct functioning of the network, accurate data transmission, proper display of information, and adherence to established technical specifications and regulatory standards. This is verified through engineering tests, software validation, and hardware testing, not clinical "ground truth" labels.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that employs a "training set."

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

• Not applicable. As no training set is used, no ground truth for a training set was established.

In summary: This 510(k) submission primarily demonstrates that the updated GE Datex-Ohmeda S/5 Network and iCentral '03, Sales Revision 3.3 is substantially equivalent to a previously cleared predicate device. The "acceptance criteria" are met through nonclinical testing verifying compliance with a comprehensive list of safety and performance standards, and through risk analysis confirming that modifications do not compromise the device's safety or effectiveness. This is a crucial distinction from AI/ML diagnostic devices, which typically require extensive clinical performance studies with defined acceptance criteria and ground truth derived from expert review, pathology, or outcomes data.

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