(147 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 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 substitute for, in whole or in part, the healthcare provider's judgment and analysis of the patient's condition.
Sim&Size is a Software as a Medical Device (SaMD) for the simulation of neurovascular implantable medical devices (IMD). The product enables visualization of cerebral blood vessels for preoperational planning for neurovascular interventions and surgery. It uses an image of the patient produced by 3D rotational angiography. It offers clinicians the possibility of computationally modeling the placement of neurovascular IMD in the artery or in the aneurysm to be treated through endovascular surgery and allows to preoperationally plan the sizing and the positioning of IMD.
Sim&Size includes four modules:
- FDsize module allows to pre-operationally plan the choice of size of flow-diverter devices;
- IDsize module allows to pre-operationally plan the choice of size of intrasaccular devices;
- STsize module allows to pre-operationally plan the choice of stents;
- FCsize module allows to pre-operationally plan the choice of first and filling embolization coils.
Associated to these four modules, a common module is intended to import DICOM images and to provide a 3D reconstruction of the vascular tree in the surgical area.
The provided documentation describes the Sim&Size device and its performance testing in support of its 510(k) submission. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document provides general statements about meeting predefined acceptance criteria but does not list specific numerical acceptance criteria or detailed reported device performance in a table format. It states:
- "The tests met the pre-defined acceptance criteria."
- "Performance testing and verification and validation activities performed have demonstrated that the device performs as intended."
- "The results of the verification and validation tests demonstrate that the device performs as intended."
Without specific criteria from the document, a detailed table cannot be created.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions that the studies used "retrospective clinical images" and "silicone phantom based on anatomy of patients presenting with intracranial aneurysms." However, specific numbers for the patient cases or phantom models in the test set are not provided.
- Data Provenance: The data used for the "predictability of the Sim&Size simulations for the Axium (Medtronic) and Hydrogel (MicroVention) embolization coils" and "predictability of the Sim&Size simulations for the overlapping flow diverters feature" were from retrospective clinical images of previously treated patients. The country of origin is not specified but since Sim&Cure is a French company, it is plausible the data originated from Europe.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
An MRMC comparative effectiveness study involving human readers' improvement with AI assistance was not explicitly mentioned or described. The studies focused on the predictability of the simulation model (software output vs. measurements from retrospective images or in-vitro tests).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies described appear to be standalone (algorithm only) performance evaluations. The document mentions "comparing the software output (volume embolization ratio) with the measurements taken from retrospective images" and "comparing the software output with the measurements taken from retrospective images." The "in-vitro and virtual coil devices implanted in silicone phantom" also suggest an algorithm-only evaluation. There is no mention of human-in-the-loop performance evaluation in these studies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for the studies appears to be:
- In-vitro measurements: For the "in-vitro and virtual coil devices implanted in silicone phantom" study, the ground truth would likely be physical measurements from the in-vitro setup.
- Measurements from retrospective clinical images: For the studies assessing the predictability of coil embolization (volume embolization ratio) and overlapping flow diverters, the ground truth was derived from "measurements taken from retrospective images of previously treated patients." This suggests expert measurements from real-world imaging.
8. The sample size for the training set
The document does not provide any details regarding the sample size or composition of the training set used for the Sim&Size software.
9. How the ground truth for the training set was established
The document does not provide any details on how the ground truth for the training set was established. It focuses solely on the performance testing of the device.
§ 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).