SkinScanMedical - Potential Medical and Research Applications
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Separate concept document - do not upload as App Store or Google Play metadata
NOT FOR STORE SUBMISSION | INVESTIGATIONAL CONCEPTS ONLY | NO CLINICAL VALIDATION CLAIM
Prepared for Orthopractis.com SMPC | 18 August 2026

CRITICAL BOUNDARY
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SkinScanMedical is not cleared, certified, or clinically validated as a medical device. It implements investigational repeat-region acquisition, registration, geometry proxies, and controlled-colour comparison, but it cannot diagnose, screen, monitor, treat, or confirm any condition. Human research requires protocol, reference standard, repeatability/accuracy studies, risk management, ethics/consent, secure governance, and regulatory assessment.

IMPLEMENTED  RESEARCH CAPABILITIES
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- User-defined bounded ROI with live centimetre rulers and metric ticks.
- Protected baseline/follow-up sessions, repeat box dimensions, and baseline ghost.
- Same-name landmarks, including optional supported Muse tip placement on visionOS.
- Landmark-first or PCA-assisted initialisation and trimmed ICP registration.
- ASCII/binary colour PLY import with units, topology disclosure, and point-cloud support.
- Registered displacement, changed-area, area/open-volume proxies, convex slice segment-volume proxy, cross sections, roughness, and symmetry descriptors.
- CIE Lab/CIEDE2000 colour trends with strict calibration-target/reference-patch/matched-acquisition gates.
- Local report/export workflows with explicit limitations and no diagnostic classifier.

REPEAT-POSITION TECHNIQUE
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1. Define anatomy, ROI label, protocol, box dimensions, body support, pose, camera distance, view path, and lighting.
2. Record at least three non-collinear same-name landmarks; four anatomical corner landmarks are preferable.
3. For colour research, include a neutral/colour target and a same-name Reference patch landmark in both sessions.
4. Save the baseline protected session/PLY.
5. At follow-up, restore dimensions, show the baseline ghost, reproduce acquisition controls, and record the same landmark names.
6. Register and inspect overlay, RMS, P95, inliers, convergence, topology, RGB coverage, and colour eligibility before interpreting change.

RESEARCH FIELD 1 - LIMB CONTOUR, EDEMA, AND SEGMENT VOLUME
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Investigators could validate whether registered bounded acquisitions provide repeatable circumference/cross-section descriptors and segment-volume proxies for phantoms or consented limbs. These values are not edema or lymphedema diagnoses and open surfaces do not directly enclose anatomical volume.

RESEARCH FIELD 2 - WOUND AND PERI-WOUND MORPHOLOGY
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Potential endpoints include registered contour, surface area when topology exists, depth/displacement proxies, peri-wound shape, and longitudinal change. The app does not segment a wound or identify infection/tissue viability.

RESEARCH FIELD 3 - SCARS, KELOIDS, BURNS, GRAFTS, AND FLAPS
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Potential endpoints include contour/roughness/symmetry change and controlled colour trends. Colour cannot confirm perfusion, graft/flap compromise, burn depth, or tissue viability.

RESEARCH FIELD 4 - POSTOPERATIVE/RECONSTRUCTIVE MORPHOLOGY
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Registered surface change and symmetry descriptors may be studied after reconstructive or aesthetic procedures on consented non-intimate regions. Do not use the app alone for surgical planning or outcome claims.

RESEARCH FIELD 5 - PRESSURE REGIONS AND DEVICE INTERFACES
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Bounded geometry could support phantom or supervised research into contour change, orthotic/prosthetic/socket/interface fit, or protective-device design. Independent engineering, fit, material, pressure, and safety validation remains necessary.

RESEARCH FIELD 6 - DERMATOLOGY DATASETS AND EDUCATION
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With ethics approval and robust governance, registered colour/shape meshes could support education or algorithm datasets. Tattoos, scars, skin colour, contours, and longitudinal labels can identify a subject; mesh data must not be assumed anonymous.

CONTROLLED COLOUR AND ACUTE LIMB SAFETY
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CIEDE2000 summarises visible colour difference; it is not blood-flow, oxygenation, or tissue-viability measurement. Do not use SkinScanMedical to confirm or exclude ischemia. A cold, painful, pale/cyanotic, numb, weak, or pulseless limb requires urgent standard clinical and vascular assessment.

SUGGESTED VALIDATION PROGRAMME
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1. Define intended use, population, anatomy, operator, device, distance, lighting, pose, topology requirement, and output metric.
2. Use traceable geometry/colour phantoms and a higher-accuracy reference scanner/colorimeter where applicable.
3. Separate acquisition, registration, topology/segmentation, colour-control, and derived-measurement error.
4. Measure within/between-session repeatability, inter-operator reproducibility, bias, limits of agreement, failure/missing-surface rate, and registration rejection rate.
5. Test skin tones, texture, curvature, hair, scars, dressings, gloss, motion, shadows, device models, and lighting spectra.
6. Predefine acceptable error, coverage, topology, RGB, reference-patch, and registration-quality thresholds.
7. Conduct human research only after ethics approval, informed consent, privacy impact assessment, and secure retention/deletion planning.
8. Obtain regulatory advice before any clinical measurement claim or patient-management use.

PROHIBITED PREMATURE CLAIMS
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- Do not claim diagnosis or confirmation of edema, lymphedema, ischemia, perfusion loss, infection, wound severity, pressure injury, scar severity, graft/flap viability, malignancy, or any condition.
- Do not claim sub-millimetre, clinical-grade, or equivalent-to-regulated-scanner accuracy from software fixtures.
- Do not interpret PCA/ICP convergence alone as anatomical correspondence or clinical validity.
- Do not place this investigational document or unsupported medical claims in public store metadata.