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Exam Vue DR is a software for the acquisition, processing, storage and viewing of two-dimensional digital radiology images. Exam Vue DR is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects. ExamVue DR is indicated for use in general radiology, specialist radiology including podiatry, orthopedic, and other specialties, and in mobile x-ray systems.

ExamVue DR is not indicated for use in mammography.

The Exam Vue DR software is designed for use by radiologists and radiology technicians for the acquisition of digital x-ray images. It interfaces with 3tt party digital x-ray detectors or CR scanners and manufacturer supplied software for the acquisition and storage of digital x-ray images. The ExamVue software then provides a user interface for the viewing, annotating, and other workstation functions. ExamVue DR includes the ability to receive patient information and send x-ray images to remote destinations using the DICOM 3.0 protocol.

The provided text is a 510(k) premarket notification for the ExamVue DR device. It describes the device's indications for use, comparison to a predicate device, and general statements about safety and performance testing. However, it does not contain specific acceptance criteria, detailed results of a study proving the device meets those criteria, or the other requested information regarding sample sizes, expert qualifications, or ground truth establishment.

The section titled "7. Safety, EMC and Performance Data" states:
"Safety testing and documentation was performed in accordance with IEEE 1012-2012, Standard for System and Software Verification and Validation. We have also provided performance and clinical testing using example X-ray detectors, as recommended by the FDA guidance document "Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices""

This indicates that performance and clinical testing were conducted, but the details of these tests, including the acceptance criteria and results, are not provided in this document.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study results or effect size
6. Standalone performance details
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

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