AEYE-DS

K221183

AEYE Health, Inc. · cleared 2022-11-10 · product code PIB · Ophthalmic

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“The AEYE-DS device is based on the main technological principle of Artificial Intelligence (AI) software as a medical device.”
AlgorithmArtificial Intelligence software
source quote (p.5)
“The AEYE-DS device is based on the main technological principle of Artificial Intelligence (AI) software as a medical device. The software as a medical device uses artificial intelligence technology to analyze specific disease features from fundus retinal images for diagnostic screening of diabetic retinopathy.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.6)
“The cybersecurity requirements for the AEYE-DS device were identified according to the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. A threat analysis was performed and documented in the Cybersecurity Report. Updates to the software are also detailed in the Cybersecurity Report.”

Validation studies (2)

Retrospective clinical

n=531 patients · 8 site(s)

endpoints: sensitivity; specificity; Positive Predictive Value (PPV); Negative Predictive Value (NPV)

standards: FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software – Software life cycle processes, ISO 14971 Medical devices – Application of risk management to medical devices, FDA Guidance - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

Bench

n=22 patients

endpoints: Intra-Operator Repeatability; Between-Operator Reproducibility; Between-Device Reproducibility

Reported performance (4 observations)

sensitivity94.7CI 85.6%; 98.2%
source quote (p.9)
“Sensitivity: 94.7% [CI: 85.6%; 98.2%]”
specificity88.6CI 85.2%; 91.4%
source quote (p.9)
“Specificity: 88.6% [CI: 85.2%; 91.4%]”
ppvas written: “PPV”54CI 44.3%; 63.4%
source quote (p.9)
“PPV: 54% [CI: 44.3%; 63.4%]”
npvas written: “NPV”99.2CI 97.6%; 99.7%
source quote (p.9)
“NPV: 99.2% [CI: 97.6%; 99.7%]”

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
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K240058 (decision 2024-04-23) from AEYE Health Inc. for a matching device line ("AEYE-DS") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K240058

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 Ophthalmic 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/K221183