(250 days)
Sim&Size enables visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. Sim&Size also allows for the ability to computationally model the placement and deployment of neurointerventional devices.
General functionalities are provided such as:
- Segmentation of neurovascular structures
- Automatic centerline detection
- Visualization of X-ray based images for 2D review and 3D reconstruction
- Placing and sizing tools
- Reporting tools
Information provided by the software is not intended in any way to eliminate, replace or in part, the healthcare provider's judgment and analysis of the patient's condition.
Sim&Size is software that allows for the preoperational planning of medical device sizes for the treatment of intracranial aneurysms. The computational modeling of neurointerventional devices, such as flow diverters and intrasaccular devices, are supported by the software to provide a patient-specific visualization of the deployment of the device from angiographic DICOM data, Information provided by the software is not intended in any way to eliminate, replace or substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.
The Sim&Size software is intended to be loaded on any Windows- or Mac-OS personal computer. A user license(s) must be purchased from the company in order to use the software after installation. The software also has a training module that offers learning assessments that are relevant to the software.
The software interacts with a patient's DICOM images, the user, and the device. To do so, the graphical interface is organized into three graphical pages (or screens):
- a. Patient selection page
- b. Module selection page
- Simulation page C.
Sim&Size was designed to enable the visualization of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. Sim&Size also allows for the ability to computationally model the placement, deployment and apposition of neurointerventional devices.
The provided document is a 510(k) summary for the Sim&Size device. It states that "All bench testing has been performed and the software has met the required specifications for the completed tests." However, it does not provide detailed acceptance criteria or the specific results of the device performance against those criteria. It also lacks information on the sample size used for the test set, data provenance, number of experts for ground truth, adjudication methods, details of comparative effectiveness studies (MRMC), standalone performance, type of ground truth used, or details regarding the training set.
Therefore, based solely on the provided text, I cannot complete the requested tables and information.
If I were to make an educated guess about the content of such a study based on the general FDA 510(k) format and the device's function (pre-operational planning and sizing in neurovascular interventions), the study would likely focus on the accuracy of measurements, segmentation, and the computational modeling of device placement against a gold standard. However, this is speculative and not found in the provided document.
Here's what can be extracted from the document regarding the performance testing, acknowledging the significant missing information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Importation of DICOM images | Met required specifications (implies successful import) |
| Patient manager functions | Met required specifications (implies proper functionality) |
| Image display and processing | Met required specifications (implies accurate display/processing) |
| Visualization of anatomic reconstruction | Met required specifications (implies accurate visualization) |
| Computational modeling of neurovascular devices | Met required specifications (implies accurate modeling) |
| Physical device deployment (verification of computational model) | Met required specifications (implies computational model accurately reflects physical deployment) |
| Report creation and visualization | Met required specifications (implies successful report generation/display) |
Note: The document only states that the device "met the required specifications" for all performed tests without detailing what those specifications were (e.g., specific accuracy thresholds, error rates, etc.).
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "angiographic DICOM data" but doesn't detail its origin or nature for the test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set:
- Adjudication Method: Not specified.
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:
- MRMC Study: Not mentioned as being performed or presented. The comparison table focuses on technological characteristics between the subject device and its predicate.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: The performance tests conducted ("bench tests") are implied to be standalone evaluations of the software's functionality and computational modeling. However, no specific "standalone performance" metrics (e.g., recall, precision for segmentation, or specific measurement accuracy) are provided in isolation from human input or a clinical context. The "Human Intervention for Interpretation of Images" characteristic is listed as "Yes" for both subject and predicate devices, suggesting that the device is intended for human-in-the-loop use.
7. The type of ground truth used:
- Type of Ground Truth: Implied to be against "required specifications" and potentially physical device deployment for verification of the computational model. For segmentation and measurements, it would typically be expert annotations or known physical measurements, but this is not explicitly stated.
8. The sample size for the training set:
- Sample Size: Not specified.
9. How the ground truth for the training set was established:
- Ground Truth Establishment: Not specified.
§ 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).