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1.3MP Medical Color Reference Display, MDC1900-1LG (ILR) is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.

1.3MP Medical Color Reference Display, MDC1900-1LG (ILR) is a 19" color LCD monitor that displays image for medical use. It provides 1.3 mega pixel (1280 x 1024/1024 x 1280) resolution and enable the user to define desired DICOM GSDF Gamma settings such as 1.8, 2.0, 2.2 and 2.4 for more precise diagnose use in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.

The provided text is a 510(k) Summary for a medical display device, not an AI/ML device. Therefore, the questions related to acceptance criteria, device performance, sample sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating AI/ML models, are not applicable in this context.

This document describes a "1.3MP Medical Color Reference Display, MDC1900-1LG (ILR)" which is a 19" color LCD monitor. The 510(k) submission states that this device is substantially equivalent to a predicate device (RadiForce R12 19" Class Color LCD Monitor by EIZO NANAO CORPORATION, K040982).

The core of a 510(k) submission for a device like this is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria in the way an AI/ML model would. Substantial equivalence is typically shown through comparison of:

1. Intended Use: Both the new device and the predicate device have the same intended use.
2. Technological Characteristics: The new device has similar technological characteristics to the predicate device.
3. Safety and Effectiveness: Differences in technological characteristics do not raise new questions of safety or effectiveness.

The document explicitly states: "1.3MP Medical Color Reference Display, MDC1900-1LG (1LR) has the same intended use as the predicate device R12, and they both share the similar characteristics except some minor differences which do not raise new questions of safety and effectiveness."

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about studies involving sample sizes, experts, or ground truth as these are not relevant to a 510(k) clearance for a display monitor based on substantial equivalence.

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