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The Invivo Research Inc. The Centurion™ Central Station Arrhythmia Patient Monitoring is intended for general hospital or clinical use by medical professionals whenever it is required to monitor patients' cardiac arrhythmias during ECG monitoring. The need to monitor these arrhythmias is most commonly encountered in the intensive care areas of the hospital during patient monitoring. This device is available for sale only upon the order of a physician or other related licensed medical professional, and not intended for any home use applications.

The Centurion™ Central Station with Arrhythmia Monitoring System is a Central Station monitor comprised of a standard VGA display, a standard Personal Computer (PC) base system, and hardware used to install the Network communications system (i.e. spreadspectrum transponders and UHF telemetry receivers). The Centurion™ Central Station with Arrhythmia Monitoring System can provide the centralized display, storage and recording (or printing) of patient vital sign and waveform data that is being monitored at the Invivo Research Inc. Millennia 3500 Series bedside monitors or spread-spectrum/UHF telemetry receivers. Data accumulated at the Millennia 3500 Series bedside monitors is sent via a proprietary spread-spectrum LAN (local area network) to the Central Station for display, storage, and/or printing. Data accumulated from any of the Invivo Research Inc. telemetry transceivers is sent directly to the Central Station on standard UHF telemetry frequencies. The Central Station oversees all communications activities, allowing each system component to pass information along without interruption of patient monitoring. The Central Station with Arrhythmia monitoring provides alarm detection and reporting for all patient parameters that are available to the Central Station, including arrhythmia monitoring for up to 8 patients. The Central Station alarm capability supplements the existing bedside monitor alarm capability (alarms at both locations). The Central Station can provide storage of patient data for 8 patients for up to 24 hours. This includes waveform and patient parameter data for all available parameter values. The waveform and parameter data that has been stored in a patient file at the Central Station can be retrieved and reviewed on the display or printed out on a thermal array recorder or laser printer.

The provided text describes a 510(k) submission for the Centurion™ Central Station with Arrhythmia Patient Monitoring System. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving device performance.

Here's what can be extracted and what is missing:

Missing Information:

• Specific Acceptance Criteria: The document states "The Invivo Research Inc. Centurion™ Central Station with Arrhythmia Monitoring System conforms with national and available international product safety standards for electrical. electromagnetic compatibility, and cardiac monitoring." and "Tests demonstrating consideration and mitigation of the identified potential hazards for this device have been developed, and will be complete before release of the device." This implies that there are acceptance criteria for safety and performance, but the actual criteria (e.g., sensitivity, specificity for arrhythmia detection, alarm accuracy thresholds) and reported device performance metrics are not provided.
• Study Details: There is no detailed description of a specific study that tested the arrhythmia detection performance of the device against predefined acceptance criteria.
• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified.
• Number of Experts/Qualifications for Ground Truth: Not specified.
• Adjudication Method: Not specified.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned, and generally not applicable for a standalone arrhythmia detection system like this.
• Standalone Performance: While the device functions as a standalone system, the specific performance metrics (like sensitivity, specificity, accuracy for arrhythmia detection) are not reported. The document only generally states it "provides alarm detection and reporting for all patient parameters... including arrhythmia monitoring for up to 8 patients."
• Type of Ground Truth: Not specified. For an arrhythmia detection system, this would typically involve expert-reviewed ECG recordings.
• Sample Size for Training Set: Not specified.
• How Ground Truth for Training Set Was Established: Not specified.

Information that can be extracted:

Here's a table based on the limited information available, with significant sections marked as "Not Provided in Document":

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance
Not provided in the document.

3. Number of Experts and Qualifications for Ground Truth
Not provided in the document.

4. Adjudication Method
Not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not mentioned in the document. This type of study is typically for image-based AI systems where human readers are interpreting data. This device is a monitoring system that directly detects arrhythmias.

6. Standalone (Algorithm only) Performance
The device itself is a standalone system for arrhythmia detection. However, specific performance metrics (e.g., sensitivity, specificity, positive predictive value, negative predictive value for different arrhythmia types) are not reported in this summary. The document only confirms its capability to perform these functions.

7. Type of Ground Truth Used
Not provided in the document. For an arrhythmia detector, ground truth would typically be established by expert cardiologists reviewing ECG recordings.

8. Sample Size for Training Set
Not provided in the document.

9. How Ground Truth for Training Set Was Established
Not provided in the document.

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