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EBM iDO Viewer software is intended to display images from CT/MR for the trained physician 's diagnosis or referring purpose. EBM iDO Viewer provides wireless and portable access to medical images. It is not intended to be used as, or to replace, a full diagnostic workstation or system and should be used only when there is no access to a workstation. This device is not to be used for mammography.

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The provided text is a 510(k) premarket notification decision letter from the FDA to EBM Technologies, Inc. for their "EBM iDO Viewer" device.

This document primarily states the FDA's "substantial equivalence" determination and provides regulatory information. It does NOT contain the detailed acceptance criteria or the study results that would prove the device meets those criteria.

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

1. A table of acceptance criteria and the reported device performance: This information is not present. The letter only states that the device is "substantially equivalent" to a predicate, meaning its performance characteristics are similar enough, but it doesn't detail the metrics or the measured performance.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. The "Indications for Use" section explicitly states it's "not intended to be used as, or to replace, a full diagnostic workstation or system," which suggests it might not have undergone a rigorous comparative effectiveness study for diagnostic accuracy improvement, but rather for its display and accessibility capabilities.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not mentioned. Given it's a viewer, its primary function is display, not independent algorithmic interpretation.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

In summary, the provided document is a regulatory approval letter and does not contain the technical study details you are asking for. These details would typically be found in the manufacturer's 510(k) submission itself, which is a much larger technical dossier.

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