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21.3 inch (54cm) Monochrome Digital Mammography 5M pixel LCD Monitor with subpixel driving techniques enabling 15M subpixels to be driven independently, MS53i2 (ML21053) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM.

MS53i2 (ML21053) is a 21.3-inch (54 cm) monochrome LCD monitor whose display resolution is 2048 x 2560 (landscape), 2560 x 2048 (portrait) supporting DVI (digital visual interface).

The provided text describes a medical device, a monochrome digital mammography LCD monitor, and its regulatory clearance process through a 510(k) submission. However, it does not contain any information about acceptance criteria, clinical studies, sample sizes, expert qualifications, or ground truth establishment relevant to the performance of the device in a diagnostic context.

The document is a US FDA 510(k) summary and clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive performance study with specific acceptance criteria as you've requested.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and study design because that information is not present in the provided text.

The information available is:

• Device Name: 21.3 inch (54 cm) Monochrome Digital Mammography LCD Monitor MS53i2 (ML21053)
• Intended Use: "displaying and viewing medical images for diagnosis by trained medical practitioners. It is to be used in digital mammography PACS and modalities including FFDM."
• Predicate Device: 5M Monochrome Digital Mammography LCD Monitor ME551i2 (MDL2116A) (K061447).
• Reason for Substantial Equivalence: Shares the same characteristics with the predicate device "except for the LCD panel and the power supply."

To answer your questions, details from a performance study demonstrating the diagnostic capabilities of the monitor would be required, which are not included in this regulatory summary.

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