A fully dynamic, formula-driven budget model for clinical validation programs. Change any assumption in the control panel on the left and every sheet updates immediately: total budget, per-study cost and cost per evaluable subject. It is pre-populated with the Oculomex myocardial infarction (MI) risk assessment validation program as the default template.
The default template
A two-part program: Study A, a retrospective dataset validation of about 26,000 subjects, and Study B, a prospective CAC association study with 270 base or 790 expanded evaluable subjects.
How to use it
- Start with the control panel on the left. Every sheet reads from it.
- Pick Lean, Base or High as the selected scenario. Each cost line carries its own Lean, Base and High value.
- Switch US only versus multi-country with country mode. Confirm FX and local costs on the Country and FX model tab before relying on multi-country numbers.
- On the Visual dashboard, switch between Internal planning view and Investor view, and choose one scenario or all three.
- Read the outputs: the Visual dashboard is the executive summary, the Detailed budget export is the line-item table, and Scenario sensitivity isolates the biggest swing drivers.
Interpreting cost outputs
- Direct cost: the sum of all active line items before contingency.
- Contingency: one global percentage (default 15%) applied to direct cost.
- Cost per evaluable subject: total cost including contingency divided by the Study B evaluable target. Evaluable subjects are always fewer than enrolled because of screen failure, dropout and low-quality images.
Oculomex Health myocardial infarction risk assessment system. Planning summary of the proposed Q-Submission validation program. Design elements are drawn from the draft clinical protocol and are subject to FDA feedback; cost figures elsewhere in this tool are planning placeholders.
Device and proposed intended use
| Element | Detail |
|---|---|
| Device | A software-based, AI-enabled screening and risk-assessment tool (Model V1). |
| Inputs | A 30 to 45 degree true color fundus photograph from the right eye, with age and sex or gender. |
| Output | A predicted MI risk score and a risk category. |
| Proposed intended use | Identify adults aged 30 to 79 without known ASCVD or subclinical atherosclerosis who may be at elevated risk of myocardial infarction and may benefit from standard-of-care cardiovascular risk assessment. Screening and risk-identification only; not diagnostic and not treatment-directing. |
| Image-quality control | Automated image-quality assessment. Low-quality images return no valid score and prompt a retake or the standard clinical workflow. |
| Proposed use environments | Optometry, ophthalmology, executive health, wellness and community screening (to be finalized). |
| Feature | Study A | Study B |
|---|---|---|
| Design | Retrospective observational validation | Prospective observational study |
| Main endpoint | Incident MI over about 10-year follow-up | Coronary artery calcium (CAC) score |
| Main purpose | Predictive validation | Biological and clinical risk-correlate validation |
| Population | Individuals with ophthalmic imaging and longitudinal follow-up | Individuals in executive health or wellness checks undergoing CT CAC scoring |
| Intervention | None; secondary analysis of existing data | None; CFP within two weeks of CAC |
| Geography | US and/or UK | US |
Primary objective. Validate model performance for prediction of myocardial infarction in real-world optometry and ophthalmology datasets with longitudinal follow-up.
Primary endpoint. Incident MI over approximately 10-year follow-up.
Secondary analyses. Performance by sex, ethnicity, age, diabetes status and ocular disease status, and across at least two CFP devices with 30 and 45 degree fields of view; exploratory left-eye analysis.
Notes. Non-interventional. Model outputs are not returned to participants, clinicians or sites. Low-quality images are excluded.
Primary objective. Evaluate the association between model outputs and Agatston CAC score, emphasizing continuous CAC analyses with threshold sensitivity analyses.
Secondary analyses. Association of high-risk classification with unrecognized cardiovascular risk factors; whether scores are modified by interventions such as statins or antihypertensives; exploratory prospective MI prediction.
Procedures. CFP acquired within two weeks of CAC scoring; cardiovascular risk factors measured if not already collected.
Notes. CAC is supportive risk-correlate evidence, not a direct proxy for MI events.
Age range. 30 to 79 years.
Key exclusions. Known ASCVD or subclinical atherosclerosis; recent ocular surgery; acute chest pain, acute coronary syndrome or emergency symptoms; poor-quality images or non-validated cameras; inability or unwillingness to undergo CAC or CFP (Study B).
Study A analysis. Discrimination (AUROC), calibration, classification (sensitivity, specificity, PPV, NPV) and clinical utility through decision-curve analysis across plausible 10-year MI risk thresholds (about 3%, 5%, 7.5% and 10%).
Study B analysis. Spearman correlation of model score with Agatston CAC; classification metrics and sensitivity analyses across CAC thresholds; Cohen kappa and odds ratios where appropriate.
| Study | Minimum | Aspirational |
|---|---|---|
| Study A | About 3,564 participants (about 106 MI events) | 26,000 participants (subgroup validation) |
| Study B | 85 (correlation) or 108 (kappa) | 790 participants (subgroup validation) |
| Item | Position |
|---|---|
| Submission | Original Q-Submission and Pre-Submission through the FDA CDRH Portal. |
| Pathway hypothesis | Evaluate a 510(k) if an appropriate predicate can be justified, with De Novo as the fallback. |
| Breakthrough Device | No Breakthrough Device request is included in this Pre-Submission. |
| Prior submissions | None for this device. |
| Comparators studied | Mediwhale (Reti-CVD, Reti-CAC) and Toku (CLAiR). |