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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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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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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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