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The intended use of the Connexall Suite of Software Products is to provide an interface with clinical systems to forward information associated to the particular event to the designated display device(s).

For medical, near real time alarms, the Connexall Suite of Software Products is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. The Connexall Suite of Software Products does not alter the behavior of the primary medical devices and associated alarm annunciations. The display device provides a visual, and/or audio and/or vibrating mechanism upon receipt of the alert.

The Connexall Suite of Software Products is intended for use as a secondary alarm. It does not replace the primary alarm function on the monitor.

The Connexall USA. Inc. (Connexall) Suite of Software Products (Software) is an on-site messaging integration solution which forwards patient monitor status and alarm information to the user via display devices provided by third-party mobile device companies. Users receive interactive, time-critical information from patient monitoring devices directly via their display devices as text, alarms or data. Connexall Software allows users to be aware of their patients' status and alarm conditions when they are away from the patient and patient monitoring system.

Connexall Software is a client/server application designed to run under any Microsoft Windows 32-bit operating system. At the core of the application is the Notification Server. The Notification Server includes the database application, system administration, licensing, and the resources to manage the near-real-time event processing and dispatching.

The Connexall Suite of Software Products is offered in four (4) configurations. These configurations include:

• Connexall Enterprise; -.
• . Connexall Pro:
• Connexall Care; and .
• Connexall LITE. .

The provided text (K112650) describes a software product, the Connexall Suite of Software Products, which is an on-site messaging integration solution that forwards patient monitor status and alarm information to users via third-party display devices. The document does not contain information about acceptance criteria or a study that rigorously proves the device meets specific performance metrics in terms of accuracy, sensitivity, specificity, or other typical diagnostic/analytic performance measures.

Instead, the performance testing section focuses on software development process compliance and verification/validation activities to establish safety and effectiveness, rather than quantitative performance against defined clinical criteria.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not define specific quantitative acceptance criteria (e.g., "alarm delivery within 5 seconds 99% of the time," or "no more than X false alarms per Y events"). The acceptance criteria are broadly related to software quality, safety, and effectiveness.

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

The document does not specify a "test set" in the context of clinical data or patient cases. The testing described is software verification and validation, which typically involves testing against pre-defined software requirements and functional specifications, not a clinical dataset. Therefore, information about sample size, country of origin, or retrospective/prospective nature is not applicable here.

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

Not applicable. The document describes software verification and validation, not a study involving clinical ground truth established by experts.

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

Not applicable. There is no mention of a test set requiring adjudication in the context of clinical or diagnostic outcomes.

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, an MRMC comparative effectiveness study was not done. This device is an alarm forwarding system, not an AI diagnostic tool that assists human readers with interpretations.

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

This refers to a software system that only forwards existing alarms from other devices. Its "standalone" performance would relate to its ability to reliably forward those alarms according to its specifications. The document states that "Test results indicated that the Connexall Suite of Software Products complies with its predetermined specifications," which implies standalone performance testing of the software's functionality. However, specific metrics are not provided.

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

The concept of "ground truth" as typically used in medical device performance evaluation (e.g., for diagnostic accuracy) is not applicable here. The "truth" against which the software was tested would be its functional requirements and specifications (e.g., "does the alarm forward correctly," "is the system stable").

8. The sample size for the training set

Not applicable. The Connexall Suite of Software Products is described as an integration and alarm forwarding solution, not an AI/machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of software.

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