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5D Viewer is a software application for the display and 3D visualization of US Volume Data measured by an ultrasound system.

This application is designed to allow the user to examine and analyze images based on volume data received from the specified ultrasound diagnostic system. It may also be used to search, and store the volume data.

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.

Main operational functions

• Display and edit volume data set
• Save data (video and volume data)
• Support simple caliper (Distance, Ellipse, or 3 Distance Volume)

Functions that require a USB-type dongle

• HDVI
• 5D Heart

5D Viewer uses the volume data of Samsung Medison's WS80A, and HS70A Ultrasound systems. The Volume Data contains the raw data obtained during the scan as well as the information required for rendering (e.g., Geometry, View mode, etc.). The patient information is not relevant to the rendering, so it is not included in the Volume Data.

The provided text is a 510(k) summary for the SAMSUNG MEDISON 5D Viewer, a software application for displaying and 3D visualizing ultrasound volume data. It mostly focuses on establishing substantial equivalence to previously cleared devices rather than providing specific acceptance criteria and detailed study results. The document states that clinical studies were not required to support substantial equivalence.

Therefore, based on the provided document, I cannot provide a complete answer to your request. However, I can extract the information available from the text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., accuracy, sensitivity, specificity). Instead, it establishes substantial equivalence based on technological characteristics and functionality compared to predicate devices. The "reported device performance" is implicitly that it performs similarly to the predicate devices in the functions listed.

Here's a table based on the functional similarity described:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "Not applicable. The subject of this submission, 5D Viewer, did not require clinical studies to support substantial equivalence." This implies there was no specific "test set" in the context of clinical performance evaluation with patient data. Non-clinical tests were conducted for conformity to voluntary standards, but detailed information about test sets for those is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical studies requiring ground truth from experts were conducted for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical studies requiring adjudication were conducted for this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The document states no clinical studies were performed. The 5D Viewer is a software for visualization and analysis, not an AI-assisted diagnostic tool that would typically undergo MRMC studies comparing human performance with and without AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This would fall under non-clinical testing for functionality and safety, which was done for compliance with IEC 62304, ISO 14971, and HIPAA, as well as Samsung Medison's own software development procedures. However, specific details or results of these standalone tests in terms of quantitative performance metrics are not provided in this summary. The device's performance is gauged through its functional equivalence to predicate devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical studies requiring ground truth were conducted for this submission.

8. The sample size for the training set

Not applicable. The device is described as a software application for display and visualization, not an AI/machine learning model requiring a training set.

9. How the ground truth for the training set was established

Not applicable, as no training set (for an AI/ML model) was described or used.

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