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The Expedio 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
The Expedio 500 A is designed to perform radiographic and fluoroscopic X-ray examinations

The Expedio 500D R&F X-ray System consists of an X-ray generator; angulating table with X-ray Tube, collimator and image intensifier; Wall stand; Overhead tube suspension; Operator Console; and Digital Archive system.

I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets any specific criteria.

The document is a 510(k) summary and an FDA clearance letter for the "Expedio 500D Radiographic and Fluoroscopic Imaging System." It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing performance data against specific acceptance criteria.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used or their qualifications.
4. Adjudication method.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information on a standalone performance study.
7. The type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

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