(167 days)
SurgicalPreview enables visualization and measurement of cerebral blood vessels for preoperational planning and sizing for neurovascular interventions and surgery. SurgicalPreview 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 CT scan images for 2D review and 3D reconstruction
- Measurement and annotation 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.
SurgicalPreview" is a stand-alone software application that runs on any standard Windows or Mac OSX based computer. It enables physicians to upload patient CT scan studies from various data sources, view them, and process the images. SurgicalPreview™ provides a clinical decision support system during the preoperative planning of endovascular surgery.
SurgicalPreview™ enables visualization and measurement of different vascular structures such as vessels, aneurysms, and other anomalies. SurgicalPreview™ also allows for the ability to computationally model the placement and deployment of neurointerventional devices. SurgicalPreview™ can reconstruct 2D scan slices into 3D models of the patient, and can display supporting DICOM CT scan data. It works with DICOM CT scan images and can access multiple DICOM data files.
The device does not contact the patient, nor does it control any life sustaining devices. 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 judgement and analysis of the patient's condition.
The provided document, a 510(k) summary for the EndoVantage SurgicalPreview device, does not contain explicit acceptance criteria or a detailed study proving the device meets specific performance criteria. Instead, it relies on a comparison to a predicate device and bench testing for validation of its functionalities.
Here's a breakdown of the information available and what is not available based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria or a table of performance metrics. It lists functionalities and describes bench tests, implying that successful completion of these tests (without specific thresholds) is considered acceptable performance.
| Functionality Tested | Reported Device Performance |
|---|---|
| Importation of DICOM images | Tests successfully completed (implied) |
| Patient manager | Tests successfully completed (implied) |
| Image display and processing | Tests successfully completed (implied) |
| Visualization of anatomic reconstruction | Tests successfully completed (implied) |
| Computational modeling (Codman Enterprise Vascular Reconstruction Device and Pipeline Embolization Device) | Tests successfully completed (implied) |
| Measurement | Tests successfully completed (implied) |
| Reports creation and visualization | Tests successfully completed (implied) |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "SurgicalPreview™ underwent bench testing to simulate clinical use." However, it does not specify:
- The sample size of cases or images used for these bench tests.
- The data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not provide information on:
- The number of experts used to establish ground truth for the bench tests.
- The qualifications of any such experts.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
The document does not mention an MRMC comparative effectiveness study or any effect size for human readers improving with AI assistance. The device is described as "clinical decision support system" and explicitly states that "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," which suggests it's an aid rather than a replacement for human interpretation.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
The document describes "bench testing" of the software's functionalities. This implies standalone performance testing of the algorithms for tasks like segmentation, centerline detection, visualization, and measurement. However, there's no explicit statement about a "standalone performance study" in the context of clinical accuracy metrics (sensitivity, specificity, etc.) against a clinical ground truth. The device is a "clinical decision support system" with "human intervention for interpretation of images."
7. The Type of Ground Truth Used:
The document mentions "bench testing" for various functionalities. The nature of the ground truth for these tests is not explicitly stated. For example, for measurement tests, it's not clear if the measurements were compared against manually acquired measurements by experts, a physical phantom, or another reference standard.
8. The Sample Size for the Training Set:
The document does not provide any information about a training set or its sample size. The device description suggests algorithmic processes (segmentation, centerline detection, computational modeling) that might involve machine learning, but no details on training data are given.
9. How the Ground Truth for the Training Set was Established:
Since no information on a training set is provided, there is no information on how its ground truth was established.
Summary of what is present:
- Device Functionalities: Segmentation, automatic centerline detection, 2D/3D visualization, measurement, annotation, reporting, computational modeling of device placement.
- Validation Method: Bench testing to validate specifications, including importation, patient manager, image display/processing, anatomic reconstruction visualization, computational modeling, measurement, and report creation.
- Regulatory Conformance: ACR/NEMA DICOM 3.1, ISO 14971:2007, IEC 62304:2006.
- Predicate Device: EndoSize (K160376), with similar intended use for preoperational planning and image data processing.
- Role of Human Intervention: Explicitly states "Human Intervention for Interpretation of Images: Yes" and that the software does not replace healthcare provider judgment.
§ 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).