(266 days)
Indications for use of the Argus Cognitive ReVISION Software are quantification and reporting of right ventricle (RV) structures and function of patients (adults only) with suspected disease to support physicians' diagnosis.
The Argus Cognitive ReVISION Software ("ReVISION Software") assesses global and segmental function of the right ventricle (RV) of the heart via the decomposition of longitudinal, radial, and anteroposterior motions of the RV walls and quantifies their relative contribution to global RV ejection fraction along with longitudinal, circumferential and area strains using 3D datasets obtained by echocardiography. Segmentation is performed on the end-diastolic 3D RV model using a rule-based, non-AI/ML algorithm to have 15 RV segments. This segmentation is then projected to all models in the corresponding cardiac cycle.
Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test (Category) | Acceptance Criteria | Reported Performance |
|---|---|---|
| Unit/Integration Testing | ||
| Mesh Processing | Mesh orientation parameters for apex, inflow, and outflow centers are within specifications. | Pass |
| Volume Calculation | Volume calculations are consistent with predicate device and are reproducible. | Pass |
| Motion Decomposition | Interobserver and intraobserver variability of decomposed end-systolic volumes are within specifications. Pre- and postoperative values for ejection fraction are reproducible. | Pass |
| Volumetric Segmentation | The relative volumes of each segment to the total volume fall within specifications. The sum of segmental volumes is equal to the global volume. Interobserver and intraobserver variability of segmental end-diastolic and end-systolic volumes are within specifications. | Pass |
| 3D Strain Calculation | Septal and free wall longitudinal strain, and global circumferential strain values are consistent with predicate device. Interobserver and intraobserver reliability of global longitudinal strain are within specifications. | Pass |
| Verification Tests | Global and segmental metrics are calculated in more than 99% of cases. When inadequate input is presented, the data is not analyzed and an error message is presented. Movement decomposition and volume calculations of known geometric data are accurate. | Pass |
| Mathematical Unit Tests | The area of a two-dimensional polygon is calculated accurately. The relations between a two-dimensional line or a three-dimensional plane and a point are calculated accurately. The closest point on a line, segment, ray, or plane to a given point is calculated accurately. The distance between two points, a segment and a point, a line and a point, a ray and a point, a plane and a point is calculated accurately. The collinearity of three points or of two lines is calculated accurately. The relation of a point to another point, line, segment, ray, plane, or polygon is calculated accurately. The intersection point of two lines, a line and a triangle, a line and a plane, a ray and a triangle, a ray and a plane is calculated accurately. The intersection of two segments, a segment and a line, a segment and a plane, a segment and a ray, a segment and a triangle is calculated accurately. The points of a polygon are not duplicated and are labeled accurately. | Pass |
| Evaluation Time | Average evaluation time must be under 15 minutes. | Pass |
| System Level Testing | ||
| Response Time | Response time must be under 10 seconds. | Pass |
| Response to Stress Conditions | No delay in the ReVISION Software functionality. | Pass |
| Validation Testing | ||
| Accuracy Validation | For segmental metrics: |
§ 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).