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2MP Medical Monochrome Reference Display, MDM2130-2NC 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.

2MP Medical Monochrome Reference Display - MDM2130-2NC.

The provided text does not contain information about acceptance criteria for a medical device or a study proving that the device meets those criteria.

Instead, the document is a 510(k) clearance letter from the FDA for a medical display (MDM2130-2NC). It states that the device has been found substantially equivalent to a predicate device and lists the standards it has met (Safety 60601-1, EMC - EN 60601-1-2, ITE Safety/EMC – EN 60950-1, CE, FCC), as well as DICOM conformance.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
6. If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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