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20.1" Monochrome LCD Monitor, RadiForce G21 is intended to be used in displaying for diagnosis of X ray or MRI, etc.

20.1" Monochrome LCD Monitor, RadiForce G21 is a display for medical use. This product complies with radiation performance standards.

This 510(k) summary describes a medical device, the EIZO NANAO RadiForce G21 monitor, but it does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

This document is a 510(k) notification, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. The information provided focuses on device description, intended use, and substantial equivalence to a predicate device, rather than performance evaluation studies.

Therefore, I cannot fulfill your request for the specific acceptance criteria and study details based on the provided text.

The closest relevant information is a comparison table between the new device (G21) and its predicate (FC-2091), which outlines various technical specifications. This implies that the acceptance criteria for the G21 would be to meet or exceed the performance of the predicate device based on these specifications. However, no formal acceptance criteria table or performance study results are presented.

Here's a breakdown of why I cannot answer your specific questions with the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The text only includes a comparison table of specifications between the proposed device and a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. No test set or data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not provided. There is no mention of a test set or ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable and not provided. This device is a monitor, not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable and not provided. This device is a monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
8. The sample size for the training set: Not applicable and not provided. This device is a monitor, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable and not provided.

The document serves as regulatory submission highlighting equivalence to a previously cleared device, not a performance study report.

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