SleepStageML

K233438

Beacon Biosignals, Inc. · cleared 2024-03-08 · product code OLZ · Neurology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“SleepStageML is a software-only medical device to be used to analyze physiological signals and automatically score sleep stages.”
Algorithmdeep learning algorithm based on convolutional neural networks
source quote (p.5)
“SleepStageML uses a deep learning algorithm based on convolutional neural networks, which was trained on a large and diverse set of PSG recordings with sleep staging labels.”
Adaptive (vs locked)Yes
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
PCCPYes
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
Cybersecurity addressedYes
source quote (p.7)
“Software operates within infrastructure that requires user authentication, encryption of data at-rest and in-transit, checksum verifications, and access controls.”

Validation studies (1)

Retrospective clinical

n=100 patients · 3 site(s)

endpoints: automatic scoring sleep study performance; positive agreement (PA); negative agreement (NA); overall agreement (OA)

standards: American Association of Sleep Medicine (AASM) recommendations, AASM guidelines

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

0
recalls in product code, 24mo
2
MAUDE reports in code, 12mo
+20%
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 Neurology 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/K233438