(89 days)
From user specified sets of CT or MR images, Realtime 3D can be used for
- 3D presentation of the couplete anatomic structure (i.e. head, chest, abdomen) covered by the original CT or MR images for diagnosis and use in treatment planning;
- diagnosing as well as treatment planning from real time Multi-Planar-Reconstruction (MPR):the Realtime 3D tool can help the user to position and visualize the 3-dimensional location of the MPR within the 3D volume by using interactive clip planes in real time;
- CTA and MRA displaying cohanced vessels;
- measurement of analomical structures in the 3D volume. Important for quantitative measurement of geometry and length of anatomy indices;
- displaying the position of anatomical structures in relationship to each other;
- navigating interactively through anatomical structures (e.g., vessels, colon, spine, lung, etc.) or inside the 3D volume;
- depth perception using the Stereo display option to visualize i.e. overlaying and underlying vessels:
- for viewing the inner surface of organs (vessels, colon, etc.);
Realtime 3D (RT3D) Diagnostic Workstation includes all the necessary hardware and software components for a medical imaging workstation that allows 3D visualization of tomographic dataset from either a CT or MR scanner together with Multiplanar Reconstructions (MPR), and allows the user to fly through or around the 3D image(s) in real time. The user can also view the 3D images in stereo and make measurements in the 3D images.
The Siemens Realtime 3D Software Package is a medical imaging workstation designed for 3D visualization of tomographic datasets from CT or MR scanners, offering Multiplanar Reconstructions (MPR), real-time "fly-through" capabilities, stereo display, and 3D measurements. It is intended to provide physicians with additional diagnostic information, assist in pre-surgical and post-surgical evaluations, and improve patient care through fast case-turnaround times.
The 510(k) summary provided does not explicitly define specific quantitative acceptance criteria or a detailed clinical study with performance metrics for the Siemens Realtime 3D Software Package. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use.
1. Table of Acceptance Criteria and Reported Device Performance
As the document does not specify quantitative acceptance criteria or detailed performance metrics, a table cannot be populated in the traditional sense. The equivalence is stated based on functional similarities.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| 3D Rendering and Visualization: Ability to display tomographic datasets in 3D space, showing spatial relationships. | The device provides 3D visualization of tomographic datasets from CT or MR, allowing users to "fly through or around" 3D images in real time and view them in stereo. |
| Multiplanar Reconstructions (MPR): Provision of MPR functionality. | The device offers MPR, with an added feature of interactive clip planes for real-time MPR. |
| Navigation Tools: Ability to navigate through anatomical structures. | Provides a "navigation tool that can be used to 'Fly around' or 'Fly through' the anatomy of interest." |
| 3D Measurement: Capability to make measurements in 3D images. | Offers 3D measurement capabilities for anatomical structures. |
| Real-time Performance: Fast image processing and display. | "Due to its real time performance, Realtime 3D provides the user with fast case-turnaround time." "RT3D has the added ability to show 3D images in real time." |
| Substantial Equivalence to Predicate Devices: Similar technological characteristics and intended use as existing marketed devices. | Stated to have the "same technological characteristics as Vitrea™ 3D Medical Visualization System" and "MagicView Workstation," with additional features. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not contain information regarding a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective nature). The submission relies on a comparison of technological characteristics to predicate devices rather than a performance study on a specific dataset.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The document does not mention the use of experts to establish ground truth for a test set, nor does it specify their number or qualifications. This type of information would typically be found in a clinical performance study, which is not detailed in this 510(k) submission.
4. Adjudication Method for the Test Set
As no specific test set or performance evaluation is described, there is no mention of an adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not discussed or presented in the provided 510(k) summary. The submission focuses on functional equivalence rather than comparative clinical performance with human readers. Therefore, an effect size comparing human readers with and without AI assistance is not available.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not described or conducted as part of this 510(k) submission. The device is a workstation with software intended for physician use, and the evaluation presented is a comparison of its features to predicate devices.
7. Type of Ground Truth Used
The document does not specify a type of ground truth used, as it doesn't detail a performance study with a specific dataset. The evaluation is based on the functional and technical capabilities of the device compared to predicate devices.
8. Sample Size for the Training Set
The provided 510(k) summary does not contain information regarding a training set or its sample size. This type of information is typically relevant for machine learning-based algorithms, which are not explicitly detailed in the context of this device's functionality beyond standard 3D rendering and processing.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, the method for establishing its ground truth is also not discussed in the 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).