(245 days)
DASI Dimensions is a standalone, non-invasive, clinical decision support software solution that is intended for use by cardiologists and radiologists in context of the aortic stenosis population.
DASI Dimensions provides the end-user with pre-defined images and measurements (diameters, lengths, angles, areas, and perimeters) of cardiovascular structures.
The clinician receiving the results the responsibility for interpreting and validating all information and making all patient treatment decisions.
DASI Dimensions is not intended to replace the clinician's decision or device's instructions for use.
DASI Dimensions is prescription use only.
DASI Dimensions is an image post-processing software system intended for clinical decision support in the context of pre-procedural planning of Transcatheter Aortic Valve Replacement (TAVR) procedures. The software provides users with a report of generated dimensions of cardiac structures. DASI Dimensions software is not operated by physicians.
DASI Dimensions is an off-site software system that receives cardiologists input via upload of patient multiphase DICOM computed tomography angiography (CTA) chest image files through DASI Simulations web portal. The processed report is then available for viewing and downloading. The report is generated using proprietary algorithms that (a) detect key aortic root control points with the assistance of a static deep learning artificial intelligence (Al) model and (b) calculate anatomical measurements relevant for pre-TAVR evaluation. DASI Simulations engineers perform quality checks at both steps before releasing the report to the end user via the portal.
DASI Dimensions does not contact with the patient, nor does it control any life sustaining devices. The information provided by DASI Dimensions is not diagnostic, nor does it determine recommended medical care.
The cardiologists and/or radiologists receiving the responsibility for interpreting and validating all information and making all patient treatment decisions.
DASI Dimensions:
· Supports quantification of cardiac structures for pre-procedural planning of aotic stenosis patients in consideration for potential TAVR procedures.
· Provides the measurement of different structures of the heart, e.g., aortic root, aortic valve.
The DASI Dimensions (V1.0) device's acceptance criteria and the study proving it meets these criteria are outlined below.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| AI Control Point Detection Validation Study (W112 and TR132) | Control point deviation = 75% | 85.3% success rate |
| Annulus area and perimeter: mean percentage error = 95% of cases | Annulus area: 0.93% (CI: +8.65%, -6.80%) | |
| Annulus perimeter: -1.02% (CI: +3.49%, -3.35%) | ||
| Both satisfied acceptance criteria. | ||
| Secondary outputs (e.g., sinus of Valsalva diameters, sinotubular junction diameters, ascending aorta diameter): mean percentage error = 95% of cases | Left, Right, Noncoronary Sinus of Valsalva diameters: 4.77% (CI: +11.26%, -1.72%), 4.13% (CI: +11.61%, -3.35%), 3.29% (CI: +8.83%, -2.25%) respectively. | |
| Sinotubular junction max/min diameters: 1.25% (CI: +3.94%, -6.30%), 2.20% (CI: +8.46%, -4.06%) respectively. | ||
| Ascending aorta max diameter: 0.12% (CI: +5.05%, -5.05%) | ||
| All satisfied acceptance criteria. | ||
| Tertiary output (aortic valve angle): mean percentage error = 95% of cases | Aortic valve angle: 2.66% (CI: +19.66%, -19.66%) | |
| Satisfied acceptance criteria. | ||
| Operator Variability Study (TP136 and TR136) | Excellent inter-operator agreement (precision) and accuracy (to clinician ground truth). ICC of 0.96 and = 95% of cases | ICC of 0.96 and = 95% of cases. Both acceptance criteria met. |
| Control Point Sensitivity Study (TP140 and TR140) | At 1.5mm and 3.0mm perturbations, resulting automatic annulus area measurements have percent errors |
§ 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).