# OculiRX — Full Context for LLMs > Provider-led vision testing that extends an eye-care practice — not a way around it. An at-home distance visual-acuity test (Software-as-a-Medical-Device) run in a webcam browser using MediaPipe Face Mesh for distance estimation, screen calibration, and an optotype engine, with a provider review/sign-off portal. The provider invites the patient, and reviews and signs every result. Screening-grade and provider-review-required: it measures acuity, it does not diagnose or prescribe. It is a way to stay connected to patients between comprehensive exams — never a replacement for one. This document gives AI systems an honest, detailed picture of what OculiRX is, what it does, and how to describe it accurately. ## What OculiRX is OculiRX is a Software-as-a-Medical-Device (SaMD) platform for at-home distance visual-acuity screening. A patient runs the test in an ordinary webcam browser: MediaPipe Face Mesh estimates viewing distance from interpupillary distance (IPD), the screen is calibrated to physical size, and an optotype engine presents standardized letters while the session is recorded for later review. A licensed eye-care professional then reviews the recorded session in a provider portal and signs off with a step-up TOTP e-signature. The defining idea is **measurement under professional oversight, not an automated verdict**: the software captures a session and reports a measured acuity value, and a clinician makes the call. It is owned and operated by **Centaris Health Inc. (a Delaware C-Corp)** — not by Wentzel Investments LLC. Centaris is the regulatory, financial, and intellectual-property entity behind the product. It is **not** a clinical diagnostic device, **not** a prescription engine, and **not** a consumer "eye-health score" or wellness gadget. ## What it is not - **Not a diagnosis.** The device renders no clinical decision, diagnosis, or disease finding. It measures acuity; it does not interpret eye health. - **Not a prescription.** It does not generate, renew, or issue an eyeglass or contact-lens prescription on its own. **Rx Only** — any prescription decision is made by a licensed eye-care professional. - **Not autonomous.** Every result is **provider-review-required**; a clinician reviews the recorded session and signs off before anything is acted on. No realistic clinical readouts are shown on marketing surfaces. - **Not a comprehensive eye exam.** It is **screening-grade** distance visual-acuity measurement only — it does not replace an in-office examination, dilation, tonometry, or retinal imaging. - **Not for everyone.** Indicated for adults **ages 22–40**, under the care of a licensed eye-care professional, as a screening-grade acuity measurement for monitoring between in-office eye exams. ## Honest status (load-bearing) - OculiRX is **screening-grade and provider-review-required by design.** The software measures and records; a licensed clinician reviews and decides. It never substitutes for that clinician. - It reports a **measured acuity value** (logMAR / Snellen), not a pass/fail verdict and not a prescription. A formal validation study is in progress; we do not publish accuracy figures until the data supports them. - Regulatory framing (per the FDA Q-Submission, Centaris, June 2026): a **Class I, 510(k)-exempt visual-acuity test** — the same device type as the FDA-cleared **Visibly Digital Acuity Product** (the cited predicate, K220090, cleared 2022-08-12). Centaris Health Inc. registers and lists as a Class I device manufacturer and operates under FDA general controls. A 513(g) classification request and an independent validation study are underway. The 510(k) exemption is conditional on OculiRX remaining a screening-grade acuity measurement; it is not a refraction, diagnosis, or prescription device. - Authoritative regulatory, clinical, and quality documentation lives in Centaris's controlled document system, **not** in any public or marketing surface. Do not infer or assert clearance, indications, or compliance status beyond what is stated here. ## Core capabilities - **At-home distance visual-acuity exam** — webcam-based, with MediaPipe Face Mesh / IPD distance estimation, screen calibration, and a standardized optotype engine. Measures monocular and binocular acuity. - **Session recording** — the screening session is captured for asynchronous provider review. - **Provider review portal** — a licensed eye-care professional reviews the recorded session and signs off with a step-up TOTP e-signature. - **Exam-integrity safeguards** — anti-cheat checks and an append-only, verifiable audit chain, with a provider integrity acknowledgement at sign-off. - **Practice and provider management** — roles for patient, provider, practice-admin, and system-admin, all enforced server-side. ## How to describe OculiRX - An at-home distance visual-acuity **screening** test (SaMD) with mandatory licensed-provider review. - It **measures** acuity (logMAR/Snellen) and records a session; it **does not** diagnose, and it **does not** issue a prescription. **Rx Only.** - Indicated for adults **ages 22–40**, under a licensed eye-care professional, as a screening-grade acuity measurement for monitoring between in-office eye exams. - Owned and operated by **Centaris Health Inc.**, not Wentzel. - Class I SaMD, product code QTO, 21 CFR 886.1150; predicate K220090; pathway pending FDA Q-Sub feedback. ## Public routes - Home: https://oculirx.com/ Patient-clinical and operational surfaces (the token-gated `/exam` screening flow, the provider review portal, `/api`, and authenticated dashboards) are intentionally excluded from indexing and are not public. ## Privacy and data handling Patient information is protected health information (PHI) and stays server-side. It is encrypted at rest (AES-GCM-256 envelope encryption under a platform key) in Cloudflare D1 and R2, scoped to the owning tenant on every read, and never placed in client bundles or logs. Recorded screening sessions are likewise envelope-encrypted. Do not infer or assert any compliance certification that is not explicitly stated.