IDx-DR

DEN180001

IDx, LLC · granted 2018-04-11 · product code PIB · Ophthalmic

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.1)
“Retinal diagnostic software device. A retinal diagnostic software device is a prescription software device that incorporates an adaptive algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions.”
Algorithmadaptive algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions
source quote (p.1)
“A retinal diagnostic software device is a prescription software device that incorporates an adaptive algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions.”
Adaptive (vs locked)Yes
source quote (p.1)
“A retinal diagnostic software device is a prescription software device that incorporates an adaptive algorithm to evaluate ophthalmic images for diagnostic screening to identify retinal diseases or conditions.”
PCCPYes
source quote (p.4)
“A protocol was provided to mitigate the risk of algorithm changes leading to changes in the device's technical specifications, which would lead to changes in false positive or false negative results. These changes could significantly affect clinical functionality or performance specifications directly associated with the intended use of the device. The protocol specifies the level of change in device specifications that could significantly affect the safety or effectiveness of the device, triggering the requirement for a 510(k) premarket notification submission before commercial introduction. This protocol implements the recommendations provided in the FDA guidance document “Deciding When to Submit a 510(k) for a Software Change to an Existing Device: Guidance for Industry and FDA Staff.””
Cybersecurity addressedYes
source quote (p.4)
“The cybersecurity considerations of data confidentiality, data integrity, data availability, denial of service attacks and malware were adequately addressed using platform controls, application controls and procedure controls and evidence was provided for the controls performance as intended.”

Validation studies (3)

Retrospective clinical

n=900 patients · 10 site(s)

endpoints: sensitivity; specificity; positive predictive value; negative predictive value

standards: ETDRS scale, DRCR grading paradigm

Standalone

n=24 patients

endpoints: repeatability; reproducibility

Bench

sample size not stated

endpoints: user interface assessment; user performance evaluation; usability mitigation

Reported performance (4 observations)

sensitivity0.874CI 81.9%-92.9%
source quote (p.7)
“IDx-DR correctly identified 173 of the 198 fully analyzable participants with fundus mtmDR+, thus observed sensitivity was at 87.4% (95%CI, 81.9% - 92.9%).”
specificity0.895CI 86.9%-93.1%
source quote (p.7)
“Among the 621 fully analyzable participants who did not have fundus mtmDR according to FPRC grading, there were 556 participants with an mtmDR not detected output, thus observed specificity was 89.5% (95% CI, 86.9%-93.1%).”
ppvas written: “Positive Predictive Value”0.727
source quote (p.7)
“Positive predictive value was 72.7% (173/238)”
npvas written: “Negative Predictive Value”0.957
source quote (p.7)
“negative predictive value was 95.7% (556/581).”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: De Novo decision summary PDF.

Predicate network

Postmarket — what happened after clearance

Not yet tracked — the weekly postmarket refresh hasn't snapshotted this device.

Reimbursement — how devices like this got paid

cat i2022-01-01

CPT 92229 (bare code — descriptor at CMS source) · MPFS rate $40.28

First Category I CPT code for a fully autonomous AI diagnostic (point-of-care retinal imaging analyzed without physician overread); CMS set national MPFS pricing in the CY2022 final rule via crosswalk. Rate applies in the physician-office (non-facility) setting. Verified national amounts: $47.06 (2022), $45.74 (2023), $40.28 (2024); the 2024 value is used because later years were not fetch-verifiable. Descriptor at the CMS/AMA source.

Eyenuk — CY2022 PFS final rule (national pricing)Ophthalmology Science (PMC) — 92229 MPFS rates 2022-2024

cat i2022-01-01

CPT 92229 (bare code — descriptor at CMS source) · OPPS rate $57.12

Hospital-outpatient companion to the office-setting MPFS rate: the CY2022 OPPS final rule assigned 92229 to APC 5733 (Level 3 Minor Procedures) at $57.12. Later-year OPPS updates were not fetch-verified. Reported separately from the MPFS figure — the two settings are never pooled.

Eyenuk — CY2022 OPPS assignment APC 5733 $57.12

3 payer coverage policies reference this clearance or its codes.

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to De Novo 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/DEN180001