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3mensio Workstation enables visualization and measurement of the heart and vessels for:

• · Pre-operational planning and sizing for cardiovascular interventions and surgery
• · Postoperative evaluation
• · Support of clinical diagnosis by quantifying dimensions in coronary arteries
• · Support of clinical diagnosis by quantifying calcifications (calcium scoring) in the coronary arteries

To facilitate the above, the 3mensio Workstation provides general functionality such as:

• · Segmentation of cardiovascular structures
• · Automatic and manual centerline detection
• · Visualization and image reconstruction techniques: 2D review, Volume Rendering, MPR, Curved MPR, Stretched
• CMPR, Slabbing, MIP, AIP, MinIP
• · Measurement and annotation tools
• Reporting tools

The 3mensio Workstation software allows cardiologists, radiologist and clinical specialists to select patient studies from various data sources, view them, and process the images with the help of a comprehensive set of tools. 3mensio Workstation works with all major medical image formats and can access multiple data stores and across networks.

3mensio Workstation can combine 2D scan slices into comprehensive 3D models of the patient, and can display supporting ultrasound and X-ray Angio data. The software accurately represents different types of tissue, making it easier to diagnose anomalies in scans.

3mensio Workstation contains two modules, 3mensio Structural Heart (containing submodule cCTA), and 3mensio Vascular which can be marketed in combination or as separate solutions:
3mensio Structural Heart enables assessment and measurement of differen structures of the heart, e.g. aortic valve, mitral valve and ventricles. It provides analysis of the feasibility of a transapical, transfemoral or subclavian approach to structures for replacement or repair procedures. 3mensio cCTA enables assessment and measurement of the coronary arteries and can help in the quantification of the dimensions of the coronary arteries and of the calcified plaques present in coronary arteries. 3mensio Vascular enables assessment of vessels and can help identify calcifications, aneurysms and other anomalies to quickly and reliably prepare for various types of vascular procedures.

The results can be displayed, printed or saved in a variety of formats to a hard disk, network, PACS system or CD. Results can also be printed as a hardcopy.

The provided document describes the 3mensio Workstation, a software device for visualizing and measuring the heart and vessels. The submission focuses on demonstrating substantial equivalence to predicate devices, particularly for newly added features: 3mensio cCTA Calcium scoring and 3mensio cCTA Coronary vessel measurement.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria (e.g., specific accuracy thresholds) for the device's performance. Instead, it relies on demonstrating that the new features are "very similar" in technology and user interface to legally marketed predicate devices and that they produce "the same results" as a comparable module in a predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the studies performed. It only mentions that a "test report comparing the numerical results of the device compared with the predicate devices is also available."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth. The nature of the comparison ("producing the same results" as predicate devices) suggests that the ground truth might implicitly be the results generated by the predicate devices, rather than a separate expert-derived ground truth.

4. Adjudication Method

The document does not specify any adjudication method for a test set.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this document. The submission focuses on technical equivalence to predicate devices, not on demonstrating improved human reader performance with AI assistance.

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

This appears to be a standalone algorithm, as the comparison is made directly between the device's numerical results and those of predicate devices. The document does not describe any human-in-the-loop performance studies, but rather the device's ability to render, segment, and measure cardiovascular structures by itself, similar to the predicate. Specifically, the "3mensio cCTA Calcium scoring" and "3mensio cCTA Coronary vessel measurement" are standalone features being compared to their counterparts in predicate devices. The overall 3mensio Workstation is a software solution for clinicians to use, but the testing reported here refers to the functional equivalence of the algorithms within it.

7. The Type of Ground Truth Used

The ground truth implicitly used for the performance comparison is the results generated by the predicate devices. The document states that the new features "produce the same results" and are "very similar" in technology and GUI interaction to the predicate devices. This indicates that the predicate's output serves as the reference for equivalence.

8. The Sample Size for the Training Set

The document does not specify any sample size for a training set. This is consistent with the nature of the submission, which is for equivalence based on functional similarity to predicates, rather than a de novo submission for a novel AI algorithm requiring extensive training data validation.

9. How the Ground Truth for the Training Set Was Established

Since no training set is described, information on how its ground truth was established is not provided.

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3mensio Workstation is a software solution that is intended to provide Cardiologists. Radiologists and Clinical Specialists additional information to aid them in reading and interpreting DICOM compliant medical images of structures of the heart and vessels.

3mensio Structural Heart enables the user to:

• Visualize and measure (diameters, lengths, areas, volumes, angles) structures . of the heart and vessels
• Quantify calcium (volume, density) .

3mensio Vascular enables the user to:

• Visualize and assess stenosis, aneurisms and vascular structures .
• Measure the dimensions of vessels (diameters, lengths, areas, volumes, . angles)

3mensio Workstation enables visualization and measurement of structures of the heart and vessels for:

• Pre-operational planning and sizing for cardiovascular interventions and . surgery
• Postoperative evaluation .

To facilitate the above, the 3mensio Workstation provides general functionality such as:

• . Segmentation of cardiovascular structures
• Automatic and manual centerline detection .
• Visualization and image reconstruction techniques: 2D review, Volume .
• Rendering, MPR, Curved MPR, Stretched CMRP, Slabbing, MIP, AIP, MinIP
• . Measurement and annotation tools
• Reporting tools .

3mensio Workstation is a stand-alone software application intended to run on a PC with a Windows operating system. It allows Cardiologists, Radiologists and Clinical Specialists to select patient studies from various data sources, view them, and process the images with the help of a comprehensive set of tools. The 3mensio Workstation contains two modules, 3mensio Structural Heart and 3mensio Vascular, which can be marketed in combination or as separate solutions. 3mensio Structural Heart enables assessment and measurement of different structures of the Heart, e.g. aortic valve, mitral valve, ventricles. It provides simple techniques to assess the feasibility of a transapical, transfemoral or subclavian approach to structures for replacement or repair procedures. 3mensio Vascular enables assessment of vessels and can help the physician identify calcifications, aneurysms and other anomalies to quickly and reliably prepare for various types of vascular surgery. The 3mensio Workstation can combine 2D scan slices into comprehensive 3D models of the patient, and can display supporting ultrasound and X-ray Angio data. The software accurately represents different types of tissue, making it easier to diagnose anomalies in scans. 3mensio Workstation works with all major medical image formats and can access multiple data stores and across networks.

Here's an analysis of the provided text regarding the acceptance criteria and study for the 3mensio Workstation device, structured to answer your questions:

Acceptance Criteria and Device Performance Study for 3mensio Workstation

Based on the provided FDA 510(k) summary (K120367), the information primarily focuses on demonstrating substantial equivalence to a predicate device (3vision/surgery, K072653). The documentation does not explicitly detail specific acceptance criteria in quantitative terms (e.g., minimum accuracy, precision, sensitivity, or specificity thresholds) for image processing or measurement tasks. Instead, the "acceptance criteria" are implied to be the successful demonstration of equivalence to the predicate device's functionality and performance.

The study described is a software verification and validation process, not a clinical trial with specific performance metrics against a clinical ground truth.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit quantitative acceptance criteria are not provided. The performance testing aimed to demonstrate that the device functions as intended and is equivalent to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of clinical images or patient cases for performance evaluation. The "tests" mentioned are software verification and validation primarily focused on functional equivalence and internal specifications. Therefore, information regarding:

• Sample size: Not specified.
• Data provenance (country of origin, retrospective/prospective): Not specified, as it's not a clinical performance study using patient data. It is implied that generic or synthetic test data would have been used for software testing to verify functionality.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. As this was primarily a software verification and validation study, not a clinical reader study comparing device measurements to expert-established ground truth on patient data, there's no mention of experts establishing a ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the described testing (software verification/validation), an adjudication method for a clinical test set is not applicable or detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned as having been done. The documentation focuses on demonstrating substantial equivalence to a predicate device through technological comparison and software verification. There is no mention of evaluating how human readers improve with or without AI assistance, as the device itself is a measurement and visualization workstation, not specifically an AI-assisted diagnostic tool in the sense of providing automated interpretations that would then be compared to human readers.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document describes standalone software verification and validation. While it doesn't explicitly refer to "algorithm only performance" in the context of AI, the testing mentioned ("evaluate the 3mensio Workstation and yield accuracy and precision results within the predetermined specifications") is inherently a standalone evaluation of the software's capabilities against its internal specifications, independent of human interaction during the testing phase. However, the device itself is intended for use by Cardiologists, Radiologists, and Clinical Specialists ("human-in-the-loop").

7. The Type of Ground Truth Used

For the described software verification and validation, the ground truth would be based on:

• Predetermined specifications: The expected output or behavior according to the software's design and requirements.
• Reference data: Potentially synthetic or carefully constructed datasets with known values to test measurement accuracy and processing fidelity.
• Comparison to predicate device's known functionality: Implicitly, the predicate device's demonstrated performance serves as a benchmark for functional equivalence.

There is no mention of ground truth established by pathology, clinical outcomes, or expert consensus on patient images for performance metrics like sensitivity/specificity.

8. The Sample Size for the Training Set

This information is not provided. The document does not describe the use of machine learning or AI models that would require a "training set" in the conventional sense. The device is described as a software application with tools for visualization, measurement, and processing, implying more traditional algorithmic approaches rather than deep learning that requires large training datasets.

9. How the Ground Truth for the Training Set Was Established

As no "training set" is described for machine learning, this question is not applicable based on the provided document.

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