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510(k) Data Aggregation
(532 days)
The Cardiovascular Suite 4.2.1 is a software program that is intended to aid trained healthcare in the quantitative analysis of vascular ultrasound images in adults, particularly for the measurement of the diameter and its changes on the brachial artery, the diameter and its changes on the carotid Intima-Media Thickness, and for carotid plaque analysis.
The Cardiovascular Suite 4.2.1 is a software indicated for estimating early cardiovascular parameters by identifying and tracking the edges of the arteries by analyzing sequences of ultrasound images or single images of the longitudinal section of the vessel. The software consists of two main functional measurement modules: 1) the FMD-Studio for measuring Flow-Mediated-Dilation (FMD) of the brachial artery, by processing sequences of ultrasound image 2) The Carotid-Studio for measuring, by processing sequences of ultrasound images, the thickness of the carotid intima-media and the instantaneous carotid diameter that, associated with a pressure estimate, can provide arterial elasticity parameters. On single images, the software also provides a tool for Plaque Measurement and Quantification. The system is able to process previously recorded video files or directly process the video output of an ultrasound system in real time.
Here's a summary of the acceptance criteria and the study details for the Cardiovascular Suite 4.2.1, based on the provided document:
Acceptance Criteria and Device Performance
The acceptance criteria are implied by the precision and accuracy metrics evaluated during the validation testing. The device is considered to meet these criteria if its performance falls within acceptable ranges for repeatability and agreement with an expert's measurements. The table below summarizes the reported device performance, which serves as the fulfillment of these implied criteria.
Table of Acceptance Criteria and Reported Device Performance
| Measurement/Metric | Acceptance Criterion (Implied by reported performance) | Reported Device Performance (Cardiovascular Suite 4.2.1) |
|---|---|---|
| FMD Studio Precision | Coefficient of Variation (CV) | |
| Intra-observer intra-session FMD% variability | ≤ 10% | 9.9% ± 8.4% (reported as 10%) |
| Intra-observer inter-session FMD% variability | ≤ 13% | 12.9% ± 11.6% (reported as 13%) |
| Shear Rate measurement precision | ≤ 2.3% (specifically stated) | 2.3% |
| Carotid Studio Precision | Coefficient of Variation (CV) | |
| Intra-session Diameter variation | ≤ 2% | 2% |
| Intra-session IMT | ≤ 6% | 6% |
| Inter-session Diameter variation | ≤ 3% | 3% |
| Inter-session Diameter variation (cardiac cycle) | ≤ 12% | 12% |
| Inter-session IMT | ≤ 6% | 6% |
| Plaque geometric and statistics (single image) | ≤ 10% |
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