(88 days)
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.
§ 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).