Search Results

The intended use of the Box View Smart Alarm Interface (SAI). Model SA-01 is to provide an interface with physiological patient monitoring systems to forward information associated to an alarm event to a designated display device(s). For medical, near real time alarms, the BoxView Smart Alarm Interface, Model SA-01 is intended to serve as a parallel, redundant, mechanism to inform healthcare professionals of particular medical alarm events. The BoxView Smart Alarm Interface, Model SA-01 does not alter the primary medical devices and associated alarm annunciations.

The BoxView Smart Alarm Interface. Model SA-01 is intended for use as a secondary alarm notification system. It does not replace the primary alarm function on the monitor.

The BoxView Smart Alarm Interface. Model SA-01 is not intended to be used for diagnostic purposes. The Box View Smart Alarm Interface, Model SA-01 is intended for use by professional clinical personnel and relies on proper use and operation of both the communication in place at the healthcare facility and the display devices used. The BoxView Smart Alarm Interface, Model SA-01 is a software product and cannot come into physical contact with patients.

The BoxView Smart Alarm Interface (SAI), Model SA-01, is a Software Medical Device (SaMD) product intended to be located on-site in the hospital, or pre-configured off site in the 'cloud' utilizing a standard Linux operating system. The primary purpose of the BoxView Smart Alarm Interface (SAI), Model SA-01 is to act as a message integrator to forward patient monitor status and alarm event information originating from a patient monitoring network. Users receive interactive, time-critical information from patient monitoring devices directly via their display devices as text, alarms or data. The BoxView Smart Alarm Interface (SAI), Model SA-01 allows caregivers to be informed of their patient's alarm conditions when they are not in the patient vicinity.

The BoxView Smart Alarm Interface (SAI), Model SA-01 is an open system that is compatible with most smart phones or computers. The BoxView Smart Alarm Interface (SAI), Model SA-01 connects to the information sources through wired Ethernet connections which are part of the customer's infrastructure. The BoxView Smart Alarm Interface (SAI), Model SA-01 software acquires patient data from patient monitoring devices and allows the user to configure the system to determine which information, including alarm notifications, is delivered to which users communicators. The BoxView Smart Alarm Interface (SAI), Model SA-01 then formats the data for delivery to the display devices.

The BoxView Smart Alarm Interface (SAI), Model SA-01 system is designed to forward alarm event information as the alarms are recognized by the patient monitoring network. The system is also capable of being configured to periodically forward a patient's physiological data as well. All messaging activities are recorded by the BoxView Smart Alarm Interface (SAI), Model SA-01 providing real-time activity logging for audit trail records and reporting.

The BoxView Smart Alarm Interface (SAI), Model SA-01, system is a secondary alarm notification system. It does not replace the primary alarm function of the bedside monitor or telemetry monitoring system.

The provided text describes the acceptance criteria and the study conducted for the BoxView Smart Alarm Interface (SAI), Model SA-01, a Software as a Medical Device (SaMD) that forwards information associated with alarm events from physiological patient monitoring systems to designated display devices.

Here's a breakdown of the requested information:

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

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

• Test Set Sample Size: The test involved simulating 250 alert/alarm messages per second from 25 concurrent alert/alarm sources. The document also mentions testing "around 400 alarm signals a second," indicating a range of simulated loads. It's a simulated environment, not real patient data.
• Data Provenance: The data used for testing was simulated. XprezzNet Simulator was used to simulate alarm messages from Spacelabs patient monitors. The testing was performed in a "simulated hospital network environment." This implies the data is synthetic and not from a specific country of origin, nor is it retrospective or prospective clinical data.

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

Not applicable. The ground truth for this device's performance testing was established by the expected behavior of the system based on its predetermined specifications (e.g., if an alarm signal matched a rule, a notification should be created and sent). It was a software functionality and performance test, not a diagnostic or clinical accuracy study requiring expert human interpretation or consensus.

4. Adjudication method for the test set

Not applicable. As noted above, this was a functional and performance test against predefined software rules and expected outputs, not a subjective assessment requiring human adjudication. The validation was done by comparing the number of sent simulated alarm signals to the number of alarm signals created in the database and checking the population of notification tables.

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 device is a "Smart Alarm Interface," a middleware that forwards alarm information. It is not an AI-powered diagnostic tool that assists human readers in interpreting medical images or data. Therefore, an MRMC comparative effectiveness study involving human readers' improvement with or without AI assistance is not relevant to this device's function or the tests described.

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

Yes, the performance testing described is a standalone (algorithm only) test. The "Smart Alarm Interface" (SAI) operates as a software product within a simulated environment, processing simulated alarm signals and generating notifications based on its configured rules. The test specifically validates the SAI's ability to process and respond to alarm signals, filter them, and create/send notifications, without direct human intervention in the real-time processing of signals.

7. The type of ground truth used

The ground truth used was based on the predetermined specifications and expected behavior of the Smart Alarm Interface application after processing simulated alarm signals. Specifically:

• Expected number of alarm signals created in the alarm database based on simulated input.
• Correct filtering of alarm signals based on predefined rules.
• Creation of corresponding notifications for matched alarm signals.
• Population of the "sendon" column in the notification table at the expected time.

8. The sample size for the training set

Not applicable. The document describes performance testing for a software interface, not a machine learning model that requires a training set. The BoxView Smart Alarm Interface (SAI) is a message integrator and secondary alarm notification system, indicating it follows predefined logic and rules, rather than learning from data.

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

Not applicable, as there was no training set for a machine learning model.

Ask a specific question about this device