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The MDNC-6121 is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

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I apologize, but the provided text from the FDA 510(k) clearance letter for the Barco Nio Color 5.8MP (MDNC-6121) monitor does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria.

The document is a standard FDA clearance letter, which states that the device is substantially equivalent to legally marketed predicate devices. It covers:

• The device name and regulation number.
• The FDA's determination of substantial equivalence.
• General controls provisions and other regulatory requirements.
• Contact information for various FDA divisions.
• The Indications for Use statement for the device.

It does not include:

• A table of acceptance criteria for performance metrics.
• Reported device performance data.
• Details about a specific validation study (e.g., sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details).

This type of detailed study information is typically found in the 510(k) submission itself, which is not publicly available in its entirety through these clearance letters. The clearance letter only summarizes the FDA's decision based on its review of the submitted data.

Therefore, I cannot fulfill your request using the provided text.

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