(71 days)
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.
| Functional Area / Characteristic | Implied Acceptance Criteria (by Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| General Functionality | All features listed for both "3mensio Workstation" and "3mensio Structural Heart / Vascular" modules should function as described and be comparable to the predicate device. | "developed and tested by 3mensio Medical Imaging according to their Quality Assurance system. Testing includes software verification and validation." The tests "yield accuracy and precision results within the predetermined specifications." (Specific values not provided). |
| Image Processing | Realign orthogonal MPRS, various segmentation tools (automatic, manual, editing), volume sculpting should perform comparably to the predicate. | Demonstrated through software verification and validation to meet specifications. |
| Image Assessment/Measurements | Linear (length, diameter), angular, ROI measurements, volume measurements, C-Arm angulation calculation functionality, and calcium scoring should be comparable to the predicate. Measurements should have acceptable accuracy and precision. | Demonstrated through software verification and validation to meet specifications, including "accuracy and precision results." (Specific values not provided). |
| Image Display | Various rendering techniques (MPR, MIP, VRT, 2D, 4D cine, etc.) should function and produce comparable visual output to the predicate. | Demonstrated through software verification and validation. |
| DICOM Support | Compatibility with various scanner vendors, DICOM datasets, import/export, query/retrieve, and printing functionalities should be similar to the predicate. | Demonstrated through software verification and validation. |
| Storage of Results | Printout, session state, PDF format, and DICOM PDF report functionality should be comparable to the predicate. | Demonstrated through software verification and validation. |
| Safety and Effectiveness | The device is safe and effective for its intended use, comparable to the predicate. | "The testing reported in this 510(k) establishes that 3mensio Workstation is substantial equivalent to the predicate device and is safe and effective for its intended use." |
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.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).