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The intended use of the Amcom™ Commtech Messenger™ (Messenger) 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, Messenger is intended to serve as a parallel, redundant, forwarding mechanism to inform healthcare professionals of particular medical related events. Messenger 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.

Messenger is intended for use as a secondary alarm. It does not replace the primary alarm function on the monitor.

Amcom™ Commtech Messenger™ (Messenger) is an intelligent software medical device, also called middleware, which forwards critical information from medical devices to the user via display devices provided by Amcom or third-party device companies. It creates an enterprise-wide hub for the management, prioritization, and response to key events. This includes the ability to send messages to the right people based on filtering and rules set up in the hospital, including escalated communications whenever necessary.

The ability of medical devices such as patient monitors (including telemetry), infusion pumps, and ventilators to provide real-time notifications of a change in condition is invaluable. These systems check physiological conditions and are linked to the patient via hard wire or wireless telemetry, depending on the patient's mobility. Getting notifications to medical staff who can take fast action not only increases patient safety, but can also save lives. Messenger allows users to be aware of their patients' status and alarm conditions when they are away from the patient and the medical devices associated with that patient.

Based on the provided 510(k) summary, here's an analysis of the acceptance criteria and study information for the Amcom™ Commtech Messenger™:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state quantitative acceptance criteria or detailed performance metrics against those criteria. Instead, it describes general compliance with predetermined specifications and applicable standards.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for any of the performance tests (software, electrical safety, EMC, bench). The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned. The testing appears to be internal validation carried out by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. The testing described is against "predetermined specifications" and "applicable standards," which implies internal validation against design requirements rather than clinical expert ground truth derivation.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as the testing appears to be functional and safety verification against predefined specifications rather than a comparative study requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The device is a "Network and Communication Middleware" for "physiological monitors" and is intended as a "secondary alarm." Its function is to forward information, not to provide diagnostic interpretations that would typically require an MRMC study. The focus is on the reliable and timely transmission of alerts.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Yes, the testing described appears to be standalone performance testing of the software and hardware components (electrical safety, EMC, bench performance) against predetermined specifications. The device itself is an "intelligent software medical device" that performs its function (forwarding information) without direct human intervention in the alert forwarding process once configured. The human is "in-the-loop" as the recipient of the alert, but the device's performance (transmission fidelity and speed) is independent of that human reaction for its core function.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing seems to be the device's own predetermined technical specifications and applicable regulatory/international standards for software, electrical safety, EMC, and general bench performance. It's not based on expert consensus, pathology, or outcomes data in a clinical sense, as the device's function is informational forwarding.

8. The Sample Size for the Training Set

No training set is mentioned. This device is described as middleware that forwards information and is not an AI/ML algorithm that requires a training set in the conventional sense. Its "intelligence" likely refers to rule-based filtering and escalation, which is typically configured rather than learned from data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is mentioned for this device.

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