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For central monitoring of multiple adult, pediatric, and neonatal patients; and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients and/or ST segment of adult patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.

The name of this device is the M3290A IntelliVue Information Center Software Release E.0 (for DataBase Server with Web Server including Near-Realtime Export). The modification is a software-based change that provides improved database server access via the hospital intra/internet system.

The PHILIPS MEDICAL SYSTEMS M3290A IntelliVue Information Center Software Release E.0 (for DataBase Server with Web Server including Near-Realtime Export) is a software-based modification designed to improve database server access via the hospital intra/internet system for central monitoring of multiple adult, pediatric, and neonatal patients. It also assists clinicians in monitoring cardiac arrhythmia and/or ST segments to inform treatment decisions.

Here's a breakdown of the acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It refers to "system level tests, integration tests, environmental tests, and safety testing."

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

The document does not mention the use of experts to establish ground truth for the test set. The validation appears to be based on engineering tests against predetermined specifications.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method. Pass/Fail criteria were based on predefined specifications from the predicate device and analysis of test results.

5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study:

A multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted. This device is a software modification for data access and monitoring, not an AI-assisted diagnostic tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study:

Yes, a standalone performance study was conducted in the form of "system level tests, integration tests, environmental tests, and safety testing" to establish the device's performance, functionality, and reliability. This testing assessed the algorithm's performance against predefined specifications, as it's a software-based system.

7. Type of Ground Truth Used:

The ground truth used for assessing the device's performance appears to be predefined technical specifications and functional requirements derived from the predicate device. The document states: "Pass/Fail criteria were based on the specifications cleared for the predicate device."

8. Sample Size for the Training Set:

The document does not mention a training set sample size because this device is a software modification and not a machine learning or AI model that requires a training phase with data for learning. Its functionality is based on established software logic and protocols.

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

As there is no mention or indication of a training set or machine learning components, there is no explanation of how a ground truth for a training set was established.

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