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3D/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.

3D/5D Viewer is a standalone software product, which can be installed on a laptop/PC with Microsoft Windows XP and 7. It allows the user to use their computer to review, analyze, edit, and measure the volume data exported from ultrasound equipment via storage media such as a USB drive. As the 3D/5D Viewer software reads 3D volume data, the users can review test results of patients more quickly and easily. This function allows them to check 3D image results without using an ultrasound system, which helps them conduct more tests with the ultrasound system.

Primary operating functions are:

• Display and editing of Volume data sets
• Data storage (image, volume data)
• Support simple Caliper (distance, Ellipse, 3 Distance volume)

Some functions that it need to USB dongle are:

• HDVI
• 5D Heart

Based on the provided text, the "3D/5D Viewer" is a software application for displaying and visualizing ultrasound volume data. The document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to predicate devices rather than providing new clinical performance data with specific acceptance criteria as one might find for a novel diagnostic AI.

Therefore, the study proving the device meets acceptance criteria in the sense of a new diagnostic AI with performance metrics (like sensitivity, specificity, or AUC) is not present in this document. The "acceptance criteria" here are instead focused on demonstrating substantial equivalence to already marketed devices, primarily by comparing technological characteristics and functionality.

Here's a breakdown based on your request, highlighting what is and isn't available in the provided text:

Study Information Pertaining to Device Performance (as would be expected for a novel AI, but not found here):

• 1. A table of acceptance criteria and the reported device performance: Not applicable/Not found. The document does not describe specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for the 3D/5D Viewer that would typically have acceptance criteria. Its acceptance is based on substantial equivalence.
• 2. Sample size used for the test set and the data provenance: Not applicable/Not found. As no clinical performance study was conducted for this submission, there's no test set or related data provenance.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not found.
• 4. Adjudication method for the test set: Not applicable/Not found.
• 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/Not found. The device is a viewer/analysis tool, not an AI to assist human readers in diagnosis. No such study was conducted or presented.
• 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/Not found. The device is a viewer for human use, not a standalone diagnostic algorithm.
• 7. The type of ground truth used: Not applicable/Not found.
• 8. The sample size for the training set: Not applicable/Not found. The document does not describe the device as an AI trained on a dataset. It's a software application for visualization and analysis of existing ultrasound data.
• 9. How the ground truth for the training set was established: Not applicable/Not found.

What is present regarding "acceptance criteria" through the lens of Substantial Equivalence:

The primary "acceptance criteria" for this 510(k) submission are based on demonstrating that the "3D/5D Viewer" is substantially equivalent to legally marketed predicate devices. This is shown by comparing its technological characteristics and intended use.

1. A table of (Technological) Acceptance Criteria and the Reported Device Performance (Comparison to Predicates):

The table provided outlines the functional "acceptance criteria" by comparing the subject device's features to those of its predicates. Its "performance" in this context is its ability to match or exceed the functionalities of the predicates.

Notes on the "Study" (in the context of Substantial Equivalence):

• Sample size and Data Provenance: Not applicable. The "study" is a comparison of technical specifications, not a clinical trial with patient data.
• Ground Truth Establishment/Experts: Not applicable. The "ground truth" for substantial equivalence is the functionality of the predicate devices already on the market.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not conducted. The document explicitly states: "The subject of this submission, 3D/5D Viewer, did not require clinical studies to support substantial equivalence."
• Standalone Performance: The device is a "standalone software product" in that it can be installed on a laptop/PC and functions independently of the ultrasound system for viewing and analysis. However, this is not a "standalone AI algorithm performance" in the diagnostic sense.
• Type of Ground Truth (for the purpose of the 510(k)): The "ground truth" for this regulatory submission is the established safety and effectiveness of the identified predicate devices (SonoView Pro™ K031886 and WS80A Diagnostic Ultrasound System K143089). The applicant demonstrates that its device performs equivalently or better in terms of features and functionality relevant to its intended use.
• Training Set Sample Size and Ground Truth for Training: Not applicable. The device is not described as a machine learning/AI model that requires training data and ground truth labels in the typical sense. It is a software application providing visualization and analysis tools.

In summary, this document is a regulatory submission demonstrating substantial equivalence through a comparison of technical features and intended use, rather than a clinical performance study with defined acceptance criteria for diagnostic accuracy or efficacy.

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