Follicle Clarity
K212012Cycle Clarity · cleared 2022-01-19 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“Follicle Clarity is a cloud-based software application package (software as a medical device, SaMD).”
source quote (p.6)
“The application measures structures within the ultrasound images using automatic segmentation technology. The software utilizes "locked" (non-adaptive) machine learning algorithms to identify the contours of the targeted structure within the ultrasound image.”
source quote (p.6)
“The software utilizes "locked" (non-adaptive) machine learning algorithms to identify the contours of the targeted structure within the ultrasound image.”
Validation studies (4)
Bench
sample size not stated
endpoints: tracking and measurement accuracy
Retrospective clinical
sample size not stated
endpoints: ovarian follicle measurements
Retrospective clinical
sample size not stated
endpoints: ovarian follicle measurements
Prospective clinical
sample size not stated
endpoints: accuracy; precision; level of agreement; median size (mm) of ovarian follicles; number of ovarian follicles identified
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).