(88 days)
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.
| Acceptance Criteria (Standards Compliance) | Reported Device Performance (Compliance Statement) |
|---|---|
| EN60950: 2000 (IEC60950 3rd edition) Product Safety | Assessed against the standard |
| EN 55022: 1998 (IEC-CISPR 22) Radio Frequency Interface | Assessed against the standard |
| EN 55024: 1998 (IEC-CISPR 24) Electromagnetic Immunity | Assessed against the standard |
| EN 61000-3-2:1995 + A1/A2/A14, Harmonic Currents | Assessed against the standard |
| EN 61000-3-3:1995, Voltage Fluctuation and Flicker | Assessed against the standard |
| EMC Directive 89/336/EEC (including amendments) | Assessed against the standard |
| Low Voltage Directive 73/23/EEC (amended by 93/68/EEC) | Assessed against the standard |
| ISO 14971:2000, Medical devices - Risk analysis | Assessed against the standard |
| IEC 60601-1-4 Medical electrical equipment. Part 1: General requirements for safety. Collateral Standard: Safety requirements for programmable medical systems. | Assessed against the standard |
| CAN/CSA-C22.2 No. 60950-00: Safety on Information Technology Equipment. | Assessed against the standard |
| UL: IEC 60950 (1999) Third Edition | Assessed against the standard |
| Overall Conclusion | "no new questions of safety and effectiveness" |
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.
§ 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).