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21.3 inch (54 cm) Color 2M pixel LCD Monitor CCL256i2 (CL21256) is intended to be used in displaying and viewing medical images for diagnosis by trained Medical practitioners. It is not meant to be used in digital mammography.

CCL256i2 (CL21256) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1200 x 1600 (landscape), 1600 x 1200 (portrait) supporting DVI (digital visual interface) and Display Port.

This document is a 510(k) summary for a medical device called the "TOTOKU 21.3 inch (54 cm) Color LCD Monitor CCL256i2 (CL21256)". It is a notification to the FDA of the intent to market the device, claiming substantial equivalence to a predicate device.

The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through empirical testing.

This document is primarily a regulatory submission for a display monitor intended for viewing medical images. The substantial equivalence claim is based on the device sharing the same characteristics as a predicate device (CCL254i2, K081055) except for the power supply.

Therefore, I cannot provide the requested information from the given text.

Here's why:

• No acceptance criteria: The document lists the device's technical specifications (e.g., screen size, resolution, interfaces) and its intended use, but it does not specify any measurable performance targets or thresholds that would typically be described as "acceptance criteria" for image quality, accuracy, or other clinical metrics.
• No study details: Since it's a display monitor, performance studies would typically involve evaluating factors like luminance, contrast ratio, uniformity, color accuracy, viewing angle, and stability, often against industry standards (e.g., DICOM Part 14, AAPM TG-18). This document does not describe any such study, its methodology, results, sample sizes, expert involvement, or ground truth.

In the context of the provided document, the "study that proves the device meets the acceptance criteria" would likely refer to internal testing performed by the manufacturer to ensure the display meets its own design specifications and relevant industry standards for medical image viewing. However, none of that information is included in this 510(k) summary.

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