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The ddRElement is a Digital Radiography system developed to be used for Medical General Radiography examinations on standing, seated and supine patients.

The ddRElement is a Digital Radiography system.

The provided text is a dated FDA clearance letter and an "Indications for Use Form" for a device called "ddR Element," a Digital Radiography system. It does not contain specific information about acceptance criteria for a study, reported device performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training sets.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes and data provenance for the test set.
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Information on multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• A standalone performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is solely an FDA letter granting substantial equivalence for a medical device based on its indications for use, without detailing specific performance studies or their methodologies.

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