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The EPSI system is intended to be used by health care professionals to integrate the video outputs from several commercially-available instruments into a single video display. These instruments may be commonly found in the electrophysiology laboratory, cardiac catheterization laboratory or where special or general fluoroscopy is used. Control of the video sources is accomplished using a touchpad device.

The EPSI is a video integration system that uses a video splitter to take the original source image from a device and send it out to a variety of locations, such as the original intended monitor, a hemodynamics recording system in the control room, etc. The split image is then sent into the EPSI system (Flat Panel LCD monitor) and a Keyboard-Video-Mouse (KVM) switch. The display on the LCD at any time is controlled by a touchpad panel.

The provided 510(k) summary for the Electrophysiology Systems Integrator (EPSI) describes a device that integrates video outputs from various medical instruments into a single display. However, it does not contain specific acceptance criteria, a detailed study protocol, or performance metrics that would typically be reported for a medical device that makes a diagnostic claim or provides quantitative results.

Based on the information provided, the EPSI device is categorized as a "Display, Cathode-Ray, Medical" (Product Code DXJ, Regulatory Class II). Its function is to display existing video outputs, not to generate new diagnostic information or to interpret medical images. Therefore, the "acceptance criteria" and "device performance" in this context are likely related to its operational functionality, electrical safety, and ability to display images accurately as provided by the source devices, rather than clinical efficacy or diagnostic accuracy.

Here's an attempt to structure the information based on your request, highlighting where information is not present in the provided document:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific numerical or objective performance metrics for image quality (e.g., resolution, latency, color accuracy), reliability (e.g., MTBF), or user interface responsiveness are not provided in this summary.
• The 510(k) summary focuses on the system's ability to perform functions and its compliance with safety standards, rather than quantitative measurements of its performance. This is typical for devices that are primarily display or interface components without diagnostic algorithms.

Study Details

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

• Sample Size: Not specified. The document states "extensive testing...during development and installation" and "all electrical safety testing," but no specific number of test cases, images, or operational hours are provided for the functional or safety tests.
• Data Provenance: Not applicable in the context of clinical data for a display device. The testing described appears to be engineering verification and validation testing, not clinical studies involving patient data.

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

• Not applicable. The device's function is to display existing video, not to make a diagnostic interpretation where expert ground truth would be required for a test set. The validation would instead involve verifying that the display accurately reproduces the input signal.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set or adjudication process is described for this type of device. Testing would likely involve technical verification against requirements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is not relevant for this device. An MRMC study evaluates the diagnostic performance of human readers, with and without AI assistance, typically for devices that produce or interpret diagnostic images. The EPSI system is a video integrator and display, not a diagnostic aid or an AI-powered diagnostic tool.

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

• No. This device is a hardware and software system for display integration and control. It does not employ a standalone algorithm that would be evaluated for performance akin to an AI or diagnostic algorithm. Its "standalone" function refers to its ability to process and display video signals, which would have been validated through engineering tests.

7. Type of Ground Truth Used

• Not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data, expert consensus). For electrical safety, the ground truth is compliance with the IEC 60601 series of standards. For display functionality, the ground truth would be the accurate reproduction of the input video signal and the proper functioning of the control interface.

8. Sample Size for the Training Set

• Not applicable. This device does not use machine learning or AI that requires a "training set" of data in the conventional sense. Its functionality is based on pre-programmed logic for video signal processing and control.

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

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

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