(28 days)
Indication for use for Web Viewer displays information received from other networked devices. It is comprised of a Mobile Care Server and Web Viewer clients. The Mobile Care Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network or Unity Network and Web Viewer clients. The Web Viewer client runs on a generic computer that is connected to the hospital local area network (LAN). The Web Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Web Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Web Viewer is not a primary alarm source. The device is for use by qualified medical personnel only.
Indication for use for Pocket Viewer. The Pocket Viewer displays information received from other networked devices. It is comprised of a Mobile Care Server and Pocket Viewer clients. The Mobile Care Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network or Unity Network and Pocket Viewer dients. The Pocket Viewer client runs on a generic handheld computer (PDA) that is connected to the hospital local area network (LAN). The Pocket Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Pocket Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Pocket Viewer is not a primary alarm source. The device is for use by qualified medical personnel only.
Indication for use for Cellular Viewer displays information received from other networked devices, It is comprised of a Mobile Care Server and Cellular Viewer clients. The Mobile Care Server maintains and coordinates the network connections between the devices in the Datex-Ohmeda Network or Unity Network and Cellular Viewer clients. The Cellular Viewer dient runs on a generic cellular phone that is connected to the hospital local area network (LAN). The Celtular Viewer can be used for viewing or otherwise processing of information from several bedside monitors or other networked devices. The Cellular Viewer can be used for patients in the hospital and it is meant for consultation and remote monitoring use. The Cellular Viewer is not a primary alarm source. The device is for use by qualified personnel only.
Not Found
Here's an analysis of the provided 510(k) document regarding acceptance criteria and supporting studies.
Based on the provided K061994 FDA 510(k) document, there is no detailed information regarding specific acceptance criteria for device performance, nor a study design with reported performance metrics that would typically be associated with AI/algorithm-based diagnostic devices.
The device described, "Web Viewer, Pocket Viewer, and Cellular Viewer with L-WEB05 software," is a set of remote monitoring devices designed to display information from other networked medical devices (bedside monitors, etc.) for consultation and remote monitoring in a hospital setting. The 510(k) submission focuses on its function as a communication and display system, not as a diagnostic algorithm or AI.
Therefore, many of the requested points in your prompt are not applicable to this specific submission. However, I can address the applicable points and explain why others cannot be answered from the provided text.
Acceptance Criteria and Study Information for K061994
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Specified for algorithmic performance. The submission primarily focuses on functional equivalence to predicate devices for remote display of physiological data. | The document does not contain specific metrics or performance data (e.g., sensitivity, specificity, accuracy, latency, resolution fidelity) for the software's display capabilities or data transmission performance. It establishes substantial equivalence to predicate devices as a remote monitoring system. |
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable / Not Provided. As this is not an AI/algorithm for diagnostic interpretation, there is no mention of a "test set" in the context of clinical data for model evaluation. The 510(k) relies on establishing substantial equivalence to predicate devices for its intended use as a data display and communication platform.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable / Not Provided. Since there's no clinical "test set" for diagnostic performance evaluation, there's no ground truth establishment by experts in the context of AI evaluation.
4. Adjudication Method for the Test Set:
- Not Applicable / Not Provided. (See point 3).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document does not describe an MRMC study. This type of study is typically conducted for diagnostic devices where human readers interpret medical images or data, and the device (with or without AI assistance) impacts their performance. The Web Viewer, Pocket Viewer, and Cellular Viewer are described as display and communication tools, not devices intended to provide diagnostic interpretations or enhance human reader performance in that way.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No. The device is a system for displaying existing patient data to qualified medical personnel. It is inherently human-in-the-loop, as the purpose is to provide information for human consultation and monitoring. There is no standalone algorithm making diagnostic decisions being evaluated.
7. Type of Ground Truth Used:
- Not Applicable / Not Provided. (See point 3).
8. Sample Size for the Training Set:
- Not Applicable / Not Provided. This document does not pertain to an AI or machine learning model that would require a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable / Not Provided. (See point 8).
Summary of Device Functionality (from the document):
The Web Viewer, Pocket Viewer, and Cellular Viewer (with L-WEB05 software) are designed to:
- Display information received from other networked medical devices (e.g., bedside monitors) from Datex-Ohmeda Network or Unity Network.
- Function as clients (running on generic computers, PDAs, or cellular phones) connected to the hospital LAN.
- Be used for consultation and remote monitoring of patients in the hospital.
- Not be a primary alarm source.
- Be used by qualified medical personnel only.
The 510(k) appears to be primarily focused on demonstrating the safety and effectiveness of this system as a means to remotely access and display existing physiological data, asserting substantial equivalence to other legally marketed remote monitoring devices. It does not present as a submission for a novel diagnostic algorithm or AI.
§ 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).