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5D Viewer is a software application for the display and 3D visualization of ultrasound volume data derived from ultrasound system. It is designed to allow the user to observe images and perform analysis using the ultrasound volume data acquired with specified diagnostic ultrasound systems. It is intended to be used for viewing, editing, measuring and storing of volume data. Typical users of this system are trained professionals, including physicians, nurses, and technicians.

5D Viewer is standalone software that can be installed in laptops/PCs with Microsoft Windows 7. This product lets users use their computers to review, analyze, edit, and measure the volume data exported from ultrasound equipment via storage media such as USB drive. Since this product reads 3D volume data, users can review the test results of patients more quickly and easily. This function allows them to check 3D image results without using an ultrasound system, helping them conduct more tests with the ultrasound system. 5D Viewer only supports the DICOM files containing the volume data created by Samsung Medison's Diagnostic Ultrasound Systems. In other words, you only use the volume data in DICOM files. 5D Viewer is not compatible with the DICOM files from third parties.

The provided document describes the 5D Viewer, a software application for displaying and visualizing ultrasound volume data. However, the document does not contain specific acceptance criteria, study details, or performance metrics for the device that would typically be found in a performance evaluation study.

The document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use, rather than presenting a performance study with acceptance criteria and measured results.

Therefore, I cannot provide the information requested in your prompt based on the provided text. Specifically:

• A table of acceptance criteria and the reported device performance: This information is not present. The document states "5D Viewer did not require clinical studies to support substantial equivalence." and focuses on technological comparisons.
• Sample sized used for the test set and the data provenance: Not applicable as a performance study with a test set is not detailed.
• Number of experts used to establish the ground truth... and qualifications: Not applicable.
• Adjudication method: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: No, the document explicitly states clinical studies were not required.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The document describes the device's main operational functions and a comparison of its features to predicate devices, but it does not detail any studies proving specific performance metrics against defined acceptance criteria. It mainly establishes equivalence based on functionality and previously cleared predicate devices.

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