Notal Vision Home Optical Coherence Tomography (OCT) System

DEN230043

Notal Vision Inc · granted 2024-05-15 · product code SAX · Ophthalmic

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.1)
“A home monitoring ophthalmic imaging device is a prescription self-imaging device that incorporates imaging system hardware and automated image processing and analysis to enable patients at home to provide measurements that are intended for use by a physician for monitoring ophthalmic diseases or conditions in between regularly scheduled assessments.”
Algorithmartificial intelligence (AI) algorithmic module for segmenting subretinal hypo-reflective spaces (SRO) and intraretinal hypo-reflective spaces (IRO) in 2D B-scans and calculating their volumes.
source quote (p.4)
“NOA is an artificial intelligence (AI) algorithmic module. NOA runs on the Notal Health Cloud and processes the volume scans generated by the VG. Its purpose is to segment the subretinal hypo-reflective spaces (SRO) and intraretinal hypo-reflective spaces (IRO) in the 2D B-scans. From this, the IRO and SRO volumes in the macular volume scan are calculated.”
Adaptive (vs locked)No
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.8)
“The NVHO system is a cyber device per 524B(c) of the Food, Drug & Cosmetic Act. Notal Vision has followed the recommendations in the Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (fda.gov) (https://www.fda.gov/media/119933/download) guidance document (September 27, 2023).”

Validation studies (3)

Bench

sample size not stated

endpoints: verify the technical specifications, spatial characteristics, device sensitivity and diopter range

standards: ANSI Z80.36:2021, IEC 60601-1: 2005, A1:2012, A2: 2020, IEC 60601-1-11:2015AMD1:2020, IEC 60601-1-2:2020, ISO 10993-1:2018

Reader study (MRMC)

n=160 patients · 7 site(s)

endpoints: positive and negative percent agreements (PPA, NPA) of central macular (central 3x3-mm area) fluid status between NVHO and RC-graded CIRRUS HD-OCT scans; success rate of initial NVHO setup; success rate for NVHO self-imaging attempts

Reader study (MRMC)

n=331 patients · 6 site(s)

endpoints: evaluate the agreement in estimated retinal fluid volume between manually segmented CIRRUS HD-OCT macular scans versus the Notal OCT Analyzer (NOA) algorithm analyzing NVHO scans; estimate the repeatability and reproducibility of the TRO parameter; evaluate the amount of overlap in segmentation of IRF and SRF between NOA and manual graders

Reported performance (2 observations)

sensitivity0.864CI 0.802, 0.926
source quote (p.15)
“The PPA was 0.864 (95% CI 0.802, 0.926; p=0.043) and NPA was 0.849 (95% CI 0.792, 0.907; p=0.094).”
specificity0.849CI 0.792, 0.907
source quote (p.15)
“The PPA was 0.864 (95% CI 0.802, 0.926; p=0.043) and NPA was 0.849 (95% CI 0.792, 0.907; p=0.094).”

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

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 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/DEN230043