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Indication for use for S/5 Web Viewer: The Datex-Ohmeda S/5 Web Viewer displays information received from other networked devices. It is comprised of a S/5 Web Server and S/5 Web Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network and S/5 Web Viewer clients. The S/5 Web Viewer client runs on a generic computer that is connected to the hospital local area network. The Datex-Ohmeda S/5 Web Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Web Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Datex-Ohmeda S/5 Web Viewer is not a primary alarm source. The device is for use by qualified medical personnel only.

Indication for use for S/5 Pocket Viewer: The Datex-Ohmeda S/5 Pocket Viewer displays information received from other networked devices. It is comprised of a S/5 Web Server and S/5 Pocket Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network and S/5 Pocket Viewer clients. The S/5 Pocket Viewer client runs on a generic handheld computer that is connected to the hospital local area network. The Datex-Ohmeda S/5 Pocket Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Pocket Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Datex-Ohmeda S/5 Pocket Viewer is not a primary alarm source. The device is for use by qualified medical personnel only.

Indication for use for S/5 Cellular Viewer: The Datex-Ohmeda S/5 Cellular Viewer displays information received from other networked devices. It is comprised of a S/5 Web Server and S/5 Cellular Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network and S/5 Cellular Viewer clients. The Datex-Ohmeda S/5 Cellular Viewer client runs on a generic cellular phone that is connected to the hospital local area network. The Datex-Ohmeda S/5 Cellular Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Cellular Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Datex-Ohmeda S/5 CellularViewer is not a primary alarm source. The device is for use by qualified personnel only.

The Datex-Ohmeda S/5 Web Viewer is a supplementary monitoring application running on a generic PC that is connected to the hospital LAN, either directly or via the Internet. It is based on the World Wide Web and Java technologies, and it is intended to be used for remote viewing of real-time patient information and trends from patient monitors that are connected to the Datex-Ohmeda S/5 Network and Central. The Pocket Viewer is a Web Viewer version running on a Pocket PC PDA that is connected to the hospital LAN via wireless access within the hospital, or via a mobile connection outside the hospital. The PDA uses a standard WLAN (802,111b) or mobile connections (GSM, GPRS, HSCSD, CDMA) to gain access to the Hospital LAN and Web Server. The Cellular Viewer is a Web Viewer version running on a generic cellular phone that is connected to the hospital LAN via a mobile connection. The mobile phone uses standard mobile connections (GSM, GPRS, HSCSD) to gain access to the Hospital LAN and Web Server. The Web Viewer, Pocket Viewer and Cellular Viewer are not primary alarm sources but decisionmaking support tools that offer clinicians access to the patient data also outside the patient care area. The network architecture of the S/5 Web/Pocket/Cellular Viewer system consists of the following components:

• Datex-Ohmeda S/5 Network that connects D-O monitors to one or more D O S/5 Centrals
• The Hospital LAN to which the office PCs in the hospital are connected to .
• . The S/5 Web Server that is connected to both of these networks
• S/5 Web Viewer client programs running in desktop and laptop PCs, S/5 Pocket Viewer client . programs running in PDAs and S/5 Cellular Viewers running in generic cellular phones
• . Optional VPN (virtual private network) or dial-up solutions enabling remote connection to patient monitoring data with the S/5 Web Viewer, Pocket Viewer and Cellular Viewer

The hospital is responsible for ensuring a secure and functional interface between the Datex-Ohmeda S/5 Network and the Hospital LAN, by utilizing, for example, a gateway, router, switch or firewall, as shown in the figure above. If the Web Viewer clients are not connected to a hospital Intranet, a regular hub can be used instead. Wireless LAN access points are required to connect the Pocket Viewer to the WLAN. For Cellular phones the proper subscriptions with the telephone operators are needed.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (e.g., performance metrics like sensitivity, specificity, or accuracy compared to a ground truth, and details about the study design with test sets, experts, etc.).

Instead, the document is a 510(k) Premarket Notification summary for the Datex-Ohmeda S/5 Web Viewer, Pocket Viewer, and Cellular Viewer with L-WEB04 software. It focuses on demonstrating substantial equivalence to a previously marketed predicate device (K033078), rather than presenting a performance study with specific acceptance criteria met by numerical results.

The "Summary of Nonclinical Testing" section (page 3) states that "Datex-Ohmeda S/5 Web Viewer, Datex-Ohmeda S/5 Pocket Viewer and Datex-Ohmeda S/5 Cellular Viewer with L-WEB04 software has been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications." It then lists various safety and EMC (Electromagnetic Compatibility) standards that the device was assessed against.

Here's a breakdown of the specific points you requested, based on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document does not provide a table with quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity) derived from a clinical or analytical study, nor does it report such performance metrics. The "acceptance criteria" discussed are compliance with international and national safety and EMC standards.

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

Not applicable. The document describes compliance with safety and EMC standards through "validation and verification of specifications," not through a test set of patient data.

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

Not applicable. This is not a study involving ground truth established by experts for a test set of data.

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

Not applicable.

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 MRMC study was mentioned. The device is a remote viewing application, not an AI diagnostic tool.

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

Not applicable. This device is a viewing application for physiological monitoring data, not an algorithm performing a standalone diagnostic or assistive function on its own.

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

Not applicable in the context of a performance study. The "ground truth" here is compliance with technical specifications and recognized safety/EMC standards.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set of data.

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

Not applicable.

In summary: The provided document is a 510(k) summary demonstrating substantial equivalence based on safety, EMC, and functional similarities to a predicate device. It does not present a clinical or analytical performance study with acceptance criteria, test sets, or expert-established ground truths as typically associated with diagnostic or AI-powered devices. The "testing" referred to is against various engineering and safety standards.

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The Datex-Ohmeda S/5 Web Viewer is intended to be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Pocket Viewer is intended to be used for viewing or otherwise processing of information from several bedside monitors or other networked devices.

Indication for use for S/5 Web Viewer: The Datex-Ohmeda S/5 Web Viewer displays information received from other networked devices. It is comprised of an S/5 Web Server and S/5 Web Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network and S/5 Web Viewer clients. The S/5 Web Viewer client runs on a generic computer that is connected to the hospital local area network. The Datex-Ohmeda S/5 Web Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Web Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Datex-Ohmeda S/5 Web Viewer is not a primary alarm source. The device is for use by qualified medical personnel only.

Indication for use for S/5 Pocket Viewer: The Datex-Ohmeda S/5 Pocket Viewer displays information received from other networked devices. It is comprised of an S/5 Web Server and S/5 Pocket Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network and S/5 Pocket Viewer clients. The S/5 Pocket Viewer client runs on a generic handheld computer that is connected to the hospital local area network. The Datex-Ohmeda S/5 Pocket Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Pocket Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Datex-Ohmeda S/5 Pocket Viewer is not a primary alarm source. The device is for use by qualified medical personnel only.

The Datex-Ohmeda S/5 Web Viewer is a supplementary monitoring application running on a generic PC that is connected to the hospital LAN, either directly or via the Internet. It is based on the World Wide Web and Java technologies, and it is intended to be used for remote viewing of real-time patient information and trends from patient monitors that are connected to the Datex-Ohmeda S/5 Network and Central. The Pocket Viewer is a Web Viewer version running on a Pocket PC PDA that is connected to the hospital LAN via wireless access within the hospital, or via a mobile connection outside the hospital. The PDA uses a standard WLAN (802.11b) or mobile connections (GSM, GPRS, HSCSD) to gain access to the Hospital LAN and Web Server. The Web Viewer and Pocket Viewer are not primary alarm sources but decision-making support tools that offer clinicians access to the patient data also outside the patient care area.

The Datex Ohmeda S/5 Web Viewer and S/5 Pocket Viewer with L-WEB03 Software is a remote monitoring device intended for viewing or otherwise processing information from several bedside monitors or other networked devices. It is meant for consultation and remote monitoring use by qualified medical personnel. It is explicitly stated that it is not a primary alarm source.

The study presented focuses on demonstrating substantial equivalence to a predicate device (Datex-Ohmeda S/5 Web Viewer version K023497), rather than establishing new performance acceptance criteria for a novel medical device. Therefore, a direct table of acceptance criteria with quantified performance metrics for a new device is not provided. Instead, the document outlines the device's adherence to relevant safety and performance standards.

Here's the information regarding the device's evaluation, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a submission for substantial equivalence based on modifications to an existing device, the "acceptance criteria" are primarily compliance with relevant safety and technical standards and demonstrating that the changes do not negatively impact safety or effectiveness compared to the predicate device. Direct measurable performance metrics as one might see for a diagnostic AI device are not applicable here.

• EN60950: 2000 (IEC60950 3rd edition) Product Safety
• EN 55022: 1998 (IEC-CISPR 22) Radio Frequency Interface
• EN 55024; 1998 (IEC-CISPR 24) Electromagnetic Immunity
• EN 61000-3-2:1995 + A1/A2/A14, Harmonic Currents
• EN 61000-3-3:1995, Voltage Fluctuation and Flicker
• EMC Directive 89/336/EEC (including amendments)
• Low Voltage Directive 73/23/EEC (amended by 93/68/EEC)
• EN 1441, Medical devices Risk analysis
• IEC 60601-1-4: Medical electrical equipment. Part 1: General requirements for safety - 4. Collateral Standard: Safety requirements for programmable medical systems.
• CAN/CSA-C22.2 No. 60950-00: Safety on Information Technology Equipment.
• UL: IEC 60950 (1999) Third Edition. | The device "complies with the safety standards below and is therefore safe and effective for the intended use." Verification of compliance with all listed mandatory and voluntary standards has been made. |

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) summary. The evaluation focuses on compliance with standards and demonstrating that software/hardware modifications do not alter safety or effectiveness, rather than a clinical performance study with a test set of patient data.
• Data Provenance: Not applicable. The submission describes functional and technical improvements to a device that displays patient data, not a device that generates or interprets diagnostic data from a patient sample.

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

• Not applicable. There is no mention of a test set requiring expert-established ground truth in this submission, as it relates to a remote viewing system's functionality and adherence to standards, not a diagnostic or AI-driven interpretive tool.

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

• Not applicable. No test set requiring adjudication is described in the document.

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. This device is a remote monitoring viewer, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is an information display system with a human-in-the-loop by design (medical personnel viewing data). It does not perform standalone algorithmic interpretations.

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

• Not applicable. As noted in point 3, the evaluation of this remote viewing device does not involve ground truth based on patient data, but rather verifying its functionality, safety, and adherence to technical specifications.

8. The sample size for the training set:

• Not applicable. This document describes a software and hardware update to a remote viewing system, not an AI/ML algorithm that requires a training set.

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

• Not applicable. As noted in point 8, there is no training set for an AI/ML algorithm relevant to this submission.

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The Datex-Ohmeda S/5 Web Viewer is intended to be used for viewing or otherwise processing of information from several bedside monitors or other networked devices.

The Datex-Ohmeda S/5 Web Viewer displays information received from other networked devices. It is comprised of a S/5 Web Server and S/5 Web Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the networked devices in Datex-Ohmeda Network and S/5 Web Viewer clients. The S/5 Web Viewer client runs on a generic computer that is connected to the hospital local area network. The Datex-Ohmeda S/5 Web Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Web Viewer will be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Datex-Ohmeda S/5 Web Viewer is not a primary alarm source. The device is for use by qualified medical personnel only.

The Datex-Ohmeda S/5 Web Viewer is a supplementary monitor running on a generic PC that is connected to the hospital LAN, either directly or via the Internet. It is based on the World Wide Web and Java technologies, and it is used for remote viewing of real-time patient information and trends from patient monitors that are connected to the Datex-Ohmeda S/5 Network and Central. The product is not a primary alarm source but a decision-making support tool that offers clinicians access to the patient data outside the patient care area.

The network architecture of the S/5 Web Viewer system consists of the following components

• Datex-Ohmeda S/5 Network that connects Datex-Ohmeda monitors to one or more Datex Ohmeda S/5 ● Centrals.
• . The Hospital LAN network to which the desktop and laptop PC's in the hospital are connected to.
• The S/5 Web Server that is connected to both of these networks that provides the S/5 Web Viewer ● clients with patient monitoring data from the D-O monitors.
• . S/5 Web Viewer client programs running in desktop and laptop PC's
• Optionally VPN (virtual private network) or dial-up solutions enabling remote connection to patient . monitoring data with the S/5 Web Viewer.

This document is a 510(k) Premarket Notification for the Datex-Ohmeda S/5 Web Viewer with L-6WV02 software. It focuses on demonstrating substantial equivalence to a predicate device (Datex-Ohmeda S/5 Web Viewer, K013387) rather than presenting a study with specific acceptance criteria and performance metrics for a novel medical AI device.

Therefore, many of the requested categories for AI device studies are not applicable or cannot be extracted from this document, as this submission predates widespread AI in medical devices and focuses on software and hardware updates for a remote monitoring system.

Here's an analysis based on the provided text, indicating where information is present or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
This document does not describe a clinical study with a "test set" in the context of an AI device's performance evaluation. The testing described is primarily non-clinical: electrical safety, EMC, mechanical/environmental tolerance, and software validation. Therefore, sample size and data provenance are not applicable in the way they would be for an AI-driven diagnostic device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment for a diagnostic test set is described as this is a software update for a remote physiological monitoring viewer.

4. Adjudication method for the test set
Not applicable. No diagnostic test set or adjudication process 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
Not applicable. This is not an AI device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a viewer for human use to monitor patient data; it is not a standalone algorithm performing automated analysis or diagnosis. Its function is to display information for qualified medical personnel.

7. The type of ground truth used
Not applicable. The validation is against engineering and software standards, functional requirements, and substantial equivalence to a predicate, not against a clinical "ground truth" for diagnostic accuracy.

8. The sample size for the training set
Not applicable. This document describes a software and hardware update for a remote monitoring system, not an AI algorithm trained on a dataset.

9. How the ground truth for the training set was established
Not applicable. See point 8.

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The Datex-Ohmeda S/5 Web Viewer displays information received from other networked devices. It is comprised of an S/5 Web Server and S/5 Web Viewer clients. The Datex-Ohmeda S/5 Web Server maintains and coordinates the network connections between the networked devices in Datex-Ohmeda Network and S/5 Web Viewer clients. The S/5 Web Viewer client runs on a generic computer that is connected to the hospital local area network. The Datex-Ohmeda S/5 Web Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Ohmeda S/5 Web Viewer will be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Datex-Ohmeda S/5 Web Viewer is not a primary alarm source. The device is for use by qualified medical personnel only.

The Web Viewer is a supplementary monitor based on the WWW-browser technology. It is meant the wed for remote viewing of real-time patient information and trends from a generic personal to be used for relieve volunial of the PC uses standard browser software to gain access to the Web Server which contains the Datex-Ohmeda specific Web Viewer software. The Web Server in turn receives the patient data from Datex-Ohmeda S/5 Central serving the Datex-Ohmeda S/5 Network. The hospital is responsible for ensuring a secure and functional interface between the Datex-Ohmeda S/5 Network and the Hospital LAN, by utilizing for example a gateway, router, switch or firewall. If the Web Viewer clients are not connected to a hospital Intranet, a regular hub can be used instead.

I am sorry, but based on the provided text, there is no information about acceptance criteria, reported device performance, or specific studies related to these. The document is a 510(k) Premarket Notification summary for the Datex-Ohmeda S/5 Web Viewer, which primarily focuses on demonstrating substantial equivalence to a predicate device.

The document discusses:

• General company information
• Device name, common name, and classification
• Predicate device
• Device description and intended use
• Summary of technological characteristics compared to the predicate device
• Summary of nonclinical testing for device compliance with safety standards (electrical safety, electromagnetic compatibility, mechanical and environmental tolerance, software validation and verification of specifications).
• A conclusion that there are no new questions of safety and effectiveness compared to the predicate device.
• The FDA's letter of substantial equivalence.
• Indications for Use.

It lists various safety and electromagnetic compatibility standards the device complies with, but it does not provide acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy), nor does it detail a study that proves the device meets such performance-based acceptance criteria with specific sample sizes, ground truth establishment, or expert involvement. The nonclinical testing mentioned is focused on compliance with engineering standards, not clinical performance or comparative effectiveness against human readers.

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