EdgeFlow UH10
Edgecare Inc.EdgeFlow UH10 is a handheld ultrasound device designed to noninvasively measure urine volume in the bladder. It uses deep learning AI to detect and outline the bladder in ultrasound images, calculates bladder volume, and displays results on its touchscreen. It supports both B-mode and harmonic imaging, helping healthcare professionals quickly assess bladder volume accurately and efficiently.
Intended Use
The EdgeFlow UH10 is an ultrasound device intended to be used for measuring the urine volume in the bladder noninvasively. It is intended for use in professional healthcare facilities, such as hospitals, clinics, by qualified and trained healthcare professionals. The EdgeFlow UH10 supports B-mode and harmonic imaging modes.
Technology
The device is a handheld ultrasound system with a 3.2 inch touchscreen and permanently attached probe. It utilizes a deep learning model with three components: feature extraction (MobileNetV2), binary classification for bladder presence, and semantic segmentation (DeepLabv3+) to delineate bladder contours and calculate bladder volume. Live B-mode ultrasound images are acquired to support detection and segmentation during scanning.
Performance
Performance testing included clinical trial data from 90 subjects with 1,528 images for segmentation and 3,711 for classification. Classification network achieved an F1 score of 0.979 and segmentation a Dice score of 0.896, meeting predefined acceptance criteria. Tests complied with relevant standards for software, electrical safety, biocompatibility, and wireless functionality, demonstrating safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/9/2023
9 months - 2
FDA Approval
3/6/2024
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