(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.
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<120367
Page 1 of 3
APR 1 7 2012
510(k) Summary
3mensio Workstation
[QA693]v2.0
| Submitter Name | Pie Medical Imaging BV | ||
|---|---|---|---|
| Submitter Address | Becanusstraat 13 D, 6216 BX Maastricht, The Netherlands | ||
| Contact Person: | Florie Daniels, Product Registration Coordinator | ||
| Phone Number | +31 43 32 81 328 | ||
| Fax Number | +31 43 32 81 329 | ||
| Email Address | Florie. Daniels@pie.nl | ||
| Preparation Date | 31 January 2012 | ||
| Trade Name | 3mensio Structural Heart / 3mensio Vascular | ||
| Common Name | 3mensio Workstation | ||
| Regulation Class | Class II (21 CFR, part 892.2050, LLZ) | ||
| Classification Name | Picture Archiving and Communications System | ||
| Predicate Devices | 3vision/surgery, cleared under K072653 | ||
| Device Description | 3mensio Workstation is a stand-alone software application intended to run on aPC with a Windows operating system. It allows Cardiologists, Radiologists andClinical Specialists to select patient studies from various data sources, view them,and process the images with the help of a comprehensive set of tools. The3mensio Workstation contains two modules, 3mensio Structural Heart and3mensio Vascular, which can be marketed in combination or as separatesolutions. 3mensio Structural Heart enables assessment and measurement ofdifferent structures of the Heart, e.g. aortic valve, mitral valve, ventricles. Itprovides simple techniques to assess the feasibility of a transapical, transfemoralor subclavian approach to structures for replacement or repair procedures.3mensio Vascular enables assessment of vessels and can help the physicianidentify calcifications, aneurysms and other anomalies to quickly and reliablyprepare for various types of vascular surgery. The 3mensio Workstation cancombine 2D scan slices into comprehensive 3D models of the patient, and candisplay supporting ultrasound and X-ray Angio data. The software accuratelyrepresents different types of tissue, making it easier to diagnose anomalies inscans. 3mensio Workstation works with all major medical image formats and canaccess multiple data stores and across networks. |
Intended Use
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)
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K120367
Page 2 of 3
Indications for use:
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 .
The technological comparision table shows the equivalence between the 3mensio Workstation software and the predicated device.
| New Device | Predicate Device |
|---|---|
| 3mensio Workstation | 3viseon/surgery |
| Pie Medical Imaging | 3mensio |
| K120367 | K072653 |
| Interface to image sources | Interface to image sources |
| DICOM image data | DICOM image data |
| Import of Patient Data | Import of Patient Data |
| Manual through keyboard/mouse | Manual through keyboard/mouse |
| Automatic import with image file | Automatic import with image file |
| Study List creation | Study List creation |
| Study list image functionality | Study list image functionality |
| Exporting | Exporting |
| Deleting | Deleting |
| Anonymizing (no automatic deletion of original patient data) | Anonymizing (no automatic deletion of original patient data) |
| Search | Search |
| Image processing: | Image processing: |
| Realign orthogonal MPRS | Realign orthogonal MPRS |
| Segmentation toolset: | Segmentation toolset: |
| - Automatic segmentation | - Automatic segmentation |
| - Automatic centreline | - Automatic centreline |
| - Manual centreline | - Manual centreline |
| - Centreline editing | - Centreline editing |
| Undo/redo operations | Undo/redo operations |
| Volume sculpting | Volume sculpting |
| Image assessment: | Image assessment: |
| Linear (length and diameter), angular and ROI measurements | Linear (length and diameter), angular and ROI measurements |
| Volume measurements | Volume measurements |
| C-Arm angulation calculation | C-Arm angulation calculation |
| Text and arrow annotations | Text and arrow annotations |
| Calcium scoring for assessment of calcium in the aortic root | Calcium scoring in vasculature |
| Image display: | Image display: |
| Orthogonal, oblique, double oblique, curved, cross-curved, stretched MPR rendering | Orthogonal, oblique, double oblique, curved, cross-curved, stretched MPR rendering |
| MIP, AvelP, MinIP and color volume slabs | MIP, AveIP, MinIP and color volume slabs |
| MIP volume rendering | MIP volume rendering |
Technological Characteristics Comparison
· Pie Medical Imaging BV
Page 2 of 3
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K1206367
Page 3 of 3
| New Device | Predicate Device |
|---|---|
| 3mensio Workstation | 3viseon/surgery |
| Pie Medical Imaging | 3mensio |
| K120367 | K072653 |
| Color volume rendering Grayscale volume rendering 2D slice review and stack comparison 4D cine Interactive VOI clipping Multi-tissue color and opacity control Active presets | Color volume rendering Grayscale volume rendering 2D slice review and stack comparison 3D view Interactive VOI clipping Multi-tissue color and opacity control Active presets |
| User-defined presets | User-defined presets |
| DICOM Support:Compatible with all scanner vendorDICOM datasets Storage SCP Import DICOM files DICOM compliance for CT, enhancedCT, MRI, enhanced MRI, XA, NuclearMedicine, CR, SC, and Ultrasound images Import from DICOMDIR Storage SCU Query/retrieve SCU Automatic grouping of images intovolumes Windows printing or send to PACS | DICOM Support:Compatible with all scanner vendorDICOM datasets Storage SCP Import DICOM files DICOM compliance for CT, MRI,XA, Nuclear Medicine, CR, SC, andUltrasound images Import from DICOMDIR Storage SCU Query/retrieve SCU Automatic grouping of images intovolumes Windows printing or send to PACS |
| Storage of ResultsPrintout Session state PDF format DICOM PDF report | Storage of ResultsPrintout Session state PDF format DICOM SC report |
| MS Windows | MS Windows |
Performance Data
3mensio Workstation is developed and tested by 3mensio Medical Imaging according to their Quality Assurance system. Testing includes software verification and validation. The tests were made to evaluate the 3mensio Workstation and yield accuracy and precision results within the predetermined specifications.
3mensio Workstation is produced and marketed under the responsibility of manufacturer Pie Medical Imaging.
Substantial Equivalence
·
Substantial Equivalence The intended use and technological characteristics of 3mensio Workstation are substantial equivalent to the intended use and technological characteristics of the predicate device.
Conclusion
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.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
APR 1 7 2012 -
Ms. Florie Daniels Regulatory Affairs Coordinator Pie Medical Imaging BV Becanusstraat 13D Maastricht, Limburg 6216 BX THE NETHERLANDS
Re: K120367
Trade/Device Name: 3mensio Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications System Regulatory Class: II Product Code: LLZ Dated: January 31, 2012 Received: February 6, 2012
Dear Ms. Daniels:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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Page 2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809); please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number:
.
Device Name: 3mensio Workstation
Indications for Use: ·
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, 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
Prescription Use 2 (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radfological Devices Vitro Diagnostic Device Evaluation and Safety Office of Ya
510K. K120367
§ 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).