Atrial Fibrillation History Feature

K213971

Apple Inc. · cleared 2022-06-03 · product code QDB · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“The Atrial Fibrillation (AFib) History Feature is an over-the-counter ("OTC") software-only mobile medical application intended for users 22 years of age and over who have a diagnosis of atrial fibrillation (AFib).”
Algorithmconvolutional neural network based architecture
source quote (p.8)
“The rhythm classification algorithm uses a convolutional neural network based architecture and was trained extensively using data collected in a number of development studies.”
Adaptive (vs locked)No
source quote (p.9)
“When development was complete the model was locked, and then evaluated on the Sequestration set as a last test to ensure it had not been over-fit to the development data.”
PCCPFDA source did not state this
Cybersecurity addressedNo

Validation studies (2)

Bench

n=2,500 patients

Retrospective clinical

n=413 patients

endpoints: accuracy of the weekly AFib burden estimate generated by the feature compared to a weekly AFib burden reference measurement

Reported performance (2 observations)

sensitivity92.6
source quote (p.12)
“Table 4. Classification Algorithm - Clinical Validation Study Performance AFib History Feature Sensitivity 92.6%”
specificity98.8
source quote (p.12)
“Table 4. Classification Algorithm - Clinical Validation Study Performance AFib History Feature Specificity 98.8%”

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K213971