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The R2 Breast Imaging Workstation is intended for the manipulation and display of x-ray images, including the primary reading of mammograms. It can show images from different acquisition/scanning devices and interfaces to various image storage and printing devices using DICOM or similar interface standards. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians and assistants.

Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.

The R2 Breast Imaging Workstation is a combination of dedicated computer software and hardware. The workstation consists of a commercially available imaging workstation and the R2 plug-in software application, which is compatible with the workstation through a Clinical Application Interface (CAI).

The provided document is a 510(k) Premarket Notification for the R2 Breast Imaging Workstation. It outlines the device's intended use, comparison to predicate devices, and the FDA's decision regarding its substantial equivalence. However, it does not contain information about acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or clinical study methodologies.

The "Studies" section {0} explicitly states: "The R2 Breast Imaging Workstation will undergo design verification tests for conformance with specifications." This indicates that at the time of this filing, the plan was to conduct such tests, but the results of those tests or any clinical studies are not included in this document.

Therefore, I cannot provide the requested information from the given text.

The closest relevant information from the document are:

• Intended Use: The R2 Breast Imaging Workstation is intended for the manipulation and display of x-ray images, including the primary reading of mammograms. It can show images from different acquisition/scanning devices and interfaces to various image storage and printing devices using DICOM or similar interface standards.
• Comparison with Predicate Devices: The submission device and the predicate device (Sectra Imaging Workstation IRS5/mx.net, K033712) have the same intended use and equivalent technological specifications. All devices support DICOM protocol for communication of images and other medical imaging devices.

These points indicate that the acceptance criteria would likely revolve around demonstrating that the workstation can effectively display and manipulate mammographic images for primary reading, similar to the predicate device, and support standard imaging protocols like DICOM. However, the specific performance metrics and the study data to prove conformance are not present.

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