Follicle Clarity
Cycle ClarityFollicle Clarity is a cloud-based AI software that helps clinicians by automatically detecting and measuring the number and size of ovarian follicles from transvaginal ultrasound images. It provides graphical and tabular summaries of these measurements to assist in fertility monitoring and related clinical decisions.
Intended Use
Follicle Clarity Software is designed to view and quantify image data acquired on compatible ultrasound systems, assisting clinicians by calculating the number and size of ovarian follicles in a transvaginal ultrasound volume sweep of the ovaries.
Technology
Follicle Clarity is a cloud-based software application using locked (non-adaptive) machine learning algorithms to automatically segment and measure hypoechoic structures (follicles) in transvaginal ultrasound images. It uses proprietary algorithms for contour identification and provides graphical and tabular measurement reports, compatible with images from multiple ultrasound vendors.
Performance
Performance testing included non-clinical validation with phantom and clinical trials comparing Follicle Clarity measurements to manual and predicate device measurements. Results demonstrated tracking and measurement accuracy within the margin of human error and substantially equivalent performance to predicate software in identifying follicle number and size.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/28/2021
6 months - 2
FDA Approval
1/19/2022
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