Support AI models to achieve ≥0.85 classification accuracy on melanoma, BCC, vitiligo, and psoriasis. Aims to support downstream classification of melanoma, basal cell carcinoma, psoriasis, seborrheic keratosis, and vitiligo. Aurora targets a ≥0.85 classification accuracy on internal validation sets at the integrated-system level.
Excluded
Scope Out
Explicitly out of scope for vendor: (1) Downstream AI classification models/pipelines, (2) Patient-facing clinical UI and EMR integration, (3) Cloud storage, HIPAA identity systems, (4) Outer enclosure industrial design.
Phase 1
Phase 1
Phase 1: Design, build, and deliver one (1) prototype/Proof of Concept (POC) system. Phase 2: Future run of approximately ten (10) systems for clinical trials followed by commercial scale-up. Multi-vendor splits or separate component sourcing are reserved options.
2. Spatial & Geometric Envelope Constraints
ID
Type
Given Requirement
Comments on it
Engineering Feasibility
MEC-1
MANDATORY
Patient Envelope: 1.0 m (W) × 0.6 m (D) × 2.0 m (H), accommodating 5th to 95th percentile standing adults. Must include light patient handholds/grips. Alternate patient envelope dimensions or accommodation of larger-bodied patients can be proposed with justification.
MEC-2
TARGET
System Footprint: Maximum floor footprint of ≤ 2.5 m × 2.5 m, with an overall system height of ≤ 2.6 m. Footprint minimization is a critical commercial parameter.
IMG-13
MANDATORY
Body-Surface Coverage: Must achieve ≥ 98% body-surface coverage on a standard anthropomorphic phantom (5th–95th percentile adult), demonstrated via a coverage-validation report.
3. Imaging & Optics Requirements
ID
Type
Given Requirement
Comments on it
Engineering Feasibility
IMG-1
MANDATORY
Camera Count: Vendor-proposed and justified against target coverage (IMG-13), Cycle Time (ROB-5), and system BOM target. Aurora's baseline assumption is a maximum of six (6) camera sensors.
IMG-2
MANDATORY
Sensor Type: Vendor-proposed to achieve resolution. Baseline assumption is a 50 Megapixel-class CMOS color sensor. Global shutter is preferred for motion robustness; Bayer or quad-Bayer array is acceptable.
IMG-3
M/T
Effective Pixel Pitch: Must be ≤ 30 µm/pixel at skin surface across working volume (M); target ≤ 15 µm/pixel in a defined high-resolution Region of Interest (ROI) mode (T).
IMG-4
MANDATORY
Bit Depth: Must be ≥ 12 bits per channel. Linear RAW format must be output alongside processed/compressed output.
IMG-5
MANDATORY
Lens Details: Low distortion (≤ 1.5% TV distortion), color-corrected, fixed or motorized focus.
IMG-6
MANDATORY
Working Distance: Optimized to fit patient envelope (MEC-1) inside spatial footprint. Vendor to specify.
IMG-7
MANDATORY
Depth of Field: Must maintain sharp focus across a body curvature of ≥ 100 mm at the set working distance.
IMG-8
MANDATORY
Color Accuracy: ΔE₀₀ ≤ 2.5 mean, ≤ 5.0 max against X-Rite ColorChecker SG and Fitzpatrick I–VI references. Performance must be documented per Fitzpatrick band; no band may exceed ΔE₀₀ mean of 3.0.
IMG-9
MANDATORY
Polarization: Support both cross-polarized and non-polarized capture switchable in under one Patient Cycle.
IMG-10
TARGET
Inter-camera color consistency: Mean ΔE₀₀ between any two camera units imaging the same target ≤ 1.5.
IMG-11
TARGET
Output formats: Lossless RAW (DNG) plus 16-bit TIFF and 8-bit JPEG. DICOM Visible Light wrap desired.
IMG-12
MANDATORY
Per-frame Metadata: Must contain Camera ID, pose ID, timestamp (µs resolution), exposure, gain, illumination state, polarization, and calibration version.
Pose Repeatability: Must be ≤ ±0.1 mm at the end-of-arm tool point.
ROB-3
TARGET
Pose Accuracy: Must be ≤ ±0.5 mm at the tool point after calibration.
ROB-4
MANDATORY
Workspace Coverage: Reach all required poses for MEC-1 envelope without patient repositioning (single standing pose with arms abducted).
ROB-6
MANDATORY
Safety Standards: Compliant with ISO 10218-1/-2 and ISO/TS 15066 (collaborative robots). Force/torque limits or proximity sensor arrays required.
ROB-7
MANDATORY
Emergency Stop: Hardwired Category-1 stop per IEC 60204-1, accessible to both operator and patient. Max stopping distance must be specified.
ROB-8
TARGET
Acoustic Noise: Must remain ≤ 60 dBA at the patient position during operation.
ROB-9
MANDATORY
Failsafe Stop: Gravity-safe rest position on power loss. Moving elements must come to a controlled halt without patient contact risk.
ROB-10
MANDATORY
Patient Detection: Automatically verify patient placement and generate alerts to the operator/patient if repositioning is required to maintain coverage.
5. Illumination Subsystem
ID
Type
Given Requirement
Comments on it
Engineering Feasibility
ILL-1
MANDATORY
Light Source: Broadband white LED, CRI ≥ 95, R9 ≥ 90, color temperature 5000–6500 K.
ILL-2
MANDATORY
Uniformity: ≤ ±10% irradiance variation across the patient envelope at the imaging plane.
ILL-3
MANDATORY
Polarization: Linearly polarized illumination paired with crossed polarizers at each camera for cross-polarized mode. Unpolarized mode also supported.
ILL-4
MANDATORY
Photobiological Safety: IEC 62471 Risk Group 1 or lower (eye-safe by design) at patient position under all programmed sequences.
ILL-5
MANDATORY
Strobe duty cycle: Capable of supporting full system cadence without thermal derating during a continuous 8-hour session.
ILL-6
MANDATORY
Spectral channels: Include at least one UV-A (365 nm) and/or 405 nm channel for pigmented-lesion enhancement, under software control.
7. Synchronization & Throughput
ID
Type
Given Requirement
Comments on it
Engineering Feasibility
ROB-5
MANDATORY
Patient Cycle Time: Full acquisition cycle (all poses, both polarizations) must complete in ≤ 90 seconds (Target: ≤ 60 seconds).
SYN-1
MANDATORY
Master Timebase: Single hardware-derived master clock distributed to all cameras, illumination, and motion controllers (PTP IEEE 1588).
SYN-2
MANDATORY
Trigger Jitter: ≤ 100 µs peak-to-peak trigger jitter across all cameras.
SYN-3
MANDATORY
Strobe Alignment: ≤ 200 µs skew between illumination strobe pulse and shutter-open.
SYN-4
TARGET
Deterministic Latency: Time from API capture command to first frame exposure start ≤ 50 ms (worst case ≤ 100 ms).
SYN-5
MANDATORY
Throughput: Aggregated sustained transfer rate of ≥ 600 MB/s from camera bank to host storage to clear buffer before next patient cycle.
6. Calibration Suite Requirements
ID
Type
Given Requirement
Comments on it
Engineering Feasibility
CAL-1
MANDATORY
Geometric: Multi-camera intrinsic and extrinsic calibration to a known target/phantom. Reprojection error must be ≤ 0.5 px RMS.
CAL-2
MANDATORY
Flat-Field: Per-camera vignetting and flat-field calibration correction.
CAL-3
MANDATORY
Color Calibration: ICC profile generation against ColorChecker SG and Fitzpatrick skin-tone reference charts. Per-camera and cross-camera profiles.
CAL-4
MANDATORY
Skin-Tone Fairness Validation: A Fitzpatrick I–VI verification protocol that produces a per-band ΔE₀₀ report and a system pass/fail. Critical acceptance gate.
CAL-5
TARGET
Drift Monitoring: On-board daily quick-check (< 2 min) flagging out-of-tolerance drift before the first patient scan.
General
MANDATORY
Must include complete calibration suite (artifacts, software, procedures) that is operator-runnable on-site in ≤ 30 minutes and fully automated thereafter.
8. Software, API & Cybersecurity Requirements
ID
Type
Given Requirement
Comments on it
Engineering Feasibility
SYN-6
MANDATORY
Control API: REST or gRPC with endpoints for pose execution, capture, status, faults, image retrieval, calibration, illumination, and polarization. OpenAPI/Protobuf schemas required.
SYN-7
MANDATORY
Session and Log Tracking: All commands, frame metadata, safety, and fault events logged with wall-clock and monotonic timestamps (minimum 30-day protected local retention).
Cyber-1
MANDATORY
Data Encryption: Local data encryption at rest for all locally stored acquisition data, logs containing acquisition data, and buffered images using AES-256. All control channels protected by TLS.
Cyber-2
MANDATORY
Data Sanitization: Access control on service interfaces; approach to data sanitization on component replacement or decommissioning. Compliance-readiness for FDA premarket cybersecurity guidance (2023) and IEC 81001-5-1. Software Bill of Materials (SBOM) required.
Pose Schedules
MANDATORY
Configurable pose schedules expressible as a versioned, declarative JSON or YAML file. Operator-facing diagnostics UI (web-based) required. Source-available service interfaces.
9. Serviceability & Lifecycle Management
ID
Type
Given Requirement
Comments on it
Engineering Feasibility
Life-1
MANDATORY
Obsolescence Assessment: Component lifecycle and end-of-life management for sensors, optics, controllers. Expected availability horizons. Mitigate single-source risks.
Life-2
MANDATORY
Component Swap: Field-component interchangeability allowing replacement without requiring full recalibration where practical. Software update/firmware rollback strategy.
Life-3
MANDATORY
Diagnostics: Modular replacement strategy with self-diagnostic capabilities to localize faults to the module level. Remote troubleshooting access.
Transfer
MANDATORY
Design transferability: Design documentation must be sufficient to support future transfer of the design to contract manufacturing partners (DFM observations).
10. Regulatory & Standards
ID
Type
Given Requirement
Comments on it
Engineering Feasibility
FDA
TARGET
FDA 510(k) Readiness: Subsystem design and documentation must support Aurora's FDA 510(k) pathway and Health Canada device licensing. 21 CFR Part 820 compliant.
IEC 60601-1
MANDATORY
Electrical Safety: IEC 60601-1 design compliance required for medical electrical equipment. Certification is optional but quotable.
IEC 60601-1-2
MANDATORY
EMC: IEC 60601-1-2 compliance required.
IEC 62304
MANDATORY
Software Lifecycle: Software classified and documented per medical device software lifecycle standards (SDP, SRS, architecture, V&V records, problem reports).
ISO 14971
MANDATORY
Risk Management: Vendor must provide a subsystem-level risk management file.
IEC 62366-1
MANDATORY
Usability Engineering: Support with subsystem use-related risk inputs (operator and service interactions).
Cleanability
MANDATORY
Cleanability: All patient-adjacent surfaces wipeable with hospital-grade disinfectants (CaviCide, 70% IPA, quaternary ammonium).
11. Deliverables & Commercial Requirements
ID
Type
Given Requirement
Comments on it
Engineering Feasibility
NRE & Cost
LIMIT
Target Bill-of-Materials (BOM) cost at production quantities is < USD $180,000 per unit. Quote must break out NRE, BOM cost, calibration suite, FAT/SAT, and indicative Phase 2 unit prices.
Warranty
MANDATORY
Provide 12-month warranty from final acceptance covering parts, labor, software defects, and on-site support. Foreground IP assigned to Aurora; background IP licensed.
Deliverables
MANDATORY
Must deliver: (1) integrated camera/positioning subsystem, (2) calibration suite, (3) coverage validation report, (4) color validation report, (5) FAT/SAT logs, (6) 2-day training course.
Spatial Settings
Gantry & Scan Settings
Automatically calculated based on actual FOV and overlap.
Sensor Details
💰 Camera Price & Budget Config
Automatically set based on chosen sensor.
Optical Settings
Targets & CoC
3D Interactive Gantry Simulator (Option A: Rotating Column)
💡 Illumination Mode
Patient Envelope:100 × 100 × 200 cm
Working Dist (WD):530 mm
Sweep Angle:0.0°
Sweep Time:0.00s
📊 Coverage Heatmap & Density Profile
2D Envelope Coverage Heatmap (360°)
Elliptical outline colored by cumulative density of 360° sweep