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CW120N LCD Monitor System is intended to be used in displaying digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications and digital breast tomosynthesis applications.

CW120N LCD Monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images.

EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards.

CW120N is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.

The provided text is related to a 510(k) premarket notification for a medical monitor system (CW120N). This document describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain information about a study proving the device meets acceptance criteria in the context of an AI/algorithm-based diagnostic device.

The "acceptance criteria" discussed in the document are limited to the performance of the display hardware itself, such as luminance, resolution, and color uniformity, and compliance with general medical electrical equipment standards (IEC 60601-1 and IEC 60601-1-2).

Therefore, based on the provided text, I cannot complete the requested table and sections regarding an AI/algorithm study. The document explicitly states: "No clinical studies were considered necessary and performed." This indicates that there was no study involving human readers, ground truth establishment, or sample sizes for diagnostic efficacy of an AI component.

Here's an explanation based on the available information:

Description of the Device and its Purpose:
The CW120N LCD Monitor System is a display device intended for viewing digital medical images, specifically for digital mammography and digital breast tomosynthesis applications. It is a hardware product, not an AI or algorithm-based diagnostic tool that interprets images. Its functionality is to accurately display images.

Acceptance Criteria for CW120N (as a display device):
The acceptance criteria are derived from bench tests to ensure the monitor's display quality and compliance with relevant standards for medical displays. These are physical and performance characteristics of the monitor, not diagnostic accuracy criteria for an AI.

Based on the provided text, the device is a medical display monitor, not an AI/algorithm-based diagnostic device. Therefore, information regarding acceptance criteria and studies for AI performance (such as sensitivity, specificity, MRMC studies, ground truth, and training sets for an algorithm) is not present in the document.

If the request implied a different type of device or study not contained within the provided text, I would not be able to generate that information.

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