--- doc_id: ASTRACBC-OCULAR-OUTLINE title: Master Outline (>100p) - Smartphone-Only Ocular-Biomarker SaMD version: v0.1-draft status: draft owner: Tambua Health Engineering audience: Cross-functional authoring team device_name: AstraCBC updated_at: 2026-02-15 ---

Master Outline (166 Pages Target)

1) TOC and Page Targets

| Section | Target pages | |---|---:| | Executive Summary | 3 | | AstraCBC Extract | 10 | | Product Definition | 12 | | Regulatory and QMS | 18 | | Optics, Capture, Ergonomics | 18 | | QC and Preprocessing | 12 | | ML Architecture and Governance | 16 | | Data Strategy and Labeling | 14 | | V&V and Clinical Trials | 16 | | Software Architecture and Operations | 15 | | UX and WCAG | 8 | | Risk Register and Safety Case | 10 | | Business and Deployment | 10 | | Claim-to-Evidence Map | 4 | | **Total** | **166** |

2) Mandatory Subsection Contract (Applies to Every Section)

Every section must include these blocks in order:

1. Overview
2. Phone-only quantitative specifications
3. Engineering trade-offs
4. Compare table
5. Block diagram or Mermaid diagram
6. Checklist
7. Figure or UI mock
8. Citation block
9. Acceptance criteria

3) Section-by-Section Build Spec

3.1 Executive Summary (3p)

• Outcome statement, risk posture, near-term go/no-go criteria
• Table: what phone-only can and cannot claim
• Diagram: end-to-end safety pipeline
• AC: executive decision and release constraints are unambiguous

3.2 AstraCBC Extract (10p)

• Full extraction from sections 4-9, 11-16, 19
• Gap matrix and ownership
• AC: no inherited assumption remains untestable

3.3 Product Definition (12p)

• Intended use, contraindications, and user populations
• Output schema and abstention behavior
• AC: product claims and output contract are internally consistent

3.4 Regulatory and QMS (18p)

• SaMD framing and classification rationale by region
• QMS map to ISO 13485 and design controls
• Clinical evaluation map to IMDRF N41 domains
• AC: all planned claims map to evidence classes and quality records

3.5 Optics, Capture, Ergonomics (18p)

• Ocular regions: conjunctiva/sclera/pupil
• Capture instructions, framing, lighting constraints
• Device capability matrix and failure contingencies
• AC: capture SOP can be executed consistently across supported devices

3.6 QC and Preprocessing (12p)

• QC metrics and thresholds (focus, motion, glare, exposure, ROI confidence)
• Reacquire and abstain rules
• AC: deterministic QC outcome with audit logs

3.7 ML Architecture and Governance (16p)

• Model stack, uncertainty, arbitration logic
• Training/inference parity and versioning
• Model cards and release criteria
• AC: each model has a bounded claim and rollback plan

3.8 Data Strategy and Labeling (14p)

• Data model, label windows, adjudication policy
• Split strategy: holdout site + holdout device family
• Synthetic stress data design
• AC: no leakage and reproducible dataset lineage

3.9 V&V and Clinical Trials (16p)

• Verification matrix + validation matrix
• Trial protocols (I/E, endpoints, monitoring, DSMB)
• SAP with worked power examples
• AC: endpoints and pass criteria frozen before enrollment

3.10 Software Architecture and Operations (15p)

• On-device and optional cloud components
• Security, privacy, observability, incident response
• PCCP-ready MLOps and controlled update process
• AC: release pipeline supports safe rollback and auditability

3.11 UX and WCAG (8p)

• Guided capture UX
• Safety language and escalation UX
• WCAG 2.2 AA conformance checklist
• AC: critical tasks are accessible and understandable

3.12 Risk Register and Safety Case (10p)

• ISO 14971 hazard analysis
• Controls, residual risk, verification evidence
• AC: no high residual risk without formal acceptance

3.13 Business and Deployment (10p)

• Device support policy, market entry sequencing, support model
• Post-market surveillance and drift operations
• AC: deployment runbook and resourcing plan complete

3.14 Claim-to-Evidence Map (4p)

• Master table: claim, risk, reference, N, study design, metrics, thresholds, subgroup gates, abstain limit
• AC: every public claim has evidence owner and acceptance gate

4) Required Tables and Diagram Inventory

Required at minimum:

• Claim-to-evidence master table
• Trial matrix and endpoint table
• Device compatibility matrix
• QC threshold table
• Hazard-control traceability table
• Mermaid system architecture diagram
• Mermaid program Gantt with go/no-go milestones

5) Quality Gates for Doc Completion

1. No section ships without explicit acceptance criteria.
2. No claim appears outside the master claim table.
3. No protocol is accepted without statistical assumptions.
4. All standards references must be cited in context.
5. External-facing statements must pass prohibited-claims checklist.