S-SYN
Synthetic Regression Fixture
Deterministic edge-case & adversarial fault-injection unit fixtures.
S-SIM
First-Principles Biophysical / Clinical Simulation
ODE/PDE hemodynamics, Beer-Lambert ray-casting, Zwanzig FEP cycles, and FHIR/DICOM state machines.
S-PUB
Locked Open Human Cohort Benchmark
SHA-256 pinned real human cohorts (ClinGen, Phenopackets, MIMIC-IV, CTU-UHB, MIT-BIH, GEO IPF, OASIS-2, ePillID, D3R GC4).
S-EXT
Zero-Physical-Custody CRO & Clinical IRB Gate
Drop-shipped ISO-17025/GLP CRO raw plate/PK ingestion & external M.D./IRB statutory validation.
S-SIGN
1-Auditor Cryptographic Sign-Off
Automated G1–G4 PASS never impersonates human sign-off; explicit principal signature required.
12-Track KHIDI Adoption & Verification Matrix (Click Any Track for 3-Pane Workbench)
Showing: 12 / 12| Wave · RFP | Track & Biophysical / Cohort Architecture | Ladder & TRL | Audited Primary Metric (G3) | Solo Score | +CRO/IRB | Audit & Statutory Gate |
|---|---|---|---|---|---|---|
| W1 · 19-1 p.104–106 | Precision Rare-Disease Genomics SaMD Joint Genotype × HPO Likelihood & ACMG-28 Rare-Disease Diagnostic CDSS | ◈ S-PUB TRL 3 → 5 | 100.00 % Causal Gene+Variant Top-5 Diagnostic Recall (Noisy HPO + VCF) (n=240) 95% CI [98.42, 100.00] · vs Genome-Wide HPO Resnik IC Phenotype-Only Ranker (4,900 Genes, Noisy HPO) 56.67 % | 89 | 96 | ✓ PASS MFDS In-Vitro Diagnostic / Genomic SaMD Analytical Performance Dossier (IEC 62304 Class B/C) |
| W1 · 11-1 [3-2] p.61–64 | Cardiovascular Digital Twin 0D–1D Cardiopulmonary RK4 Hemodynamic Digital Twin & Counterfactual Therapy Engine | ◈ S-PUB TRL 3 → 5 | 0.8392 AUROC Held-Out ICU Hypotensive Instability (MAP < 65 mmHg) Prediction AUROC (n=137) 95% CI [0.7604, 0.9145] · vs Early Window Static Shock-Index / Linear Windkessel Baseline 0.6536 AUROC | 87 | 95 | ✓ PASS ASME V&V 40 Credibility Assessment for Computational Modeling in Medical Devices |
| W1 · 11-1 [1-2] p.61–64 | Musculoskeletal Radiographic Mensuration SaMD 3D Beer-Lambert CT→DRR Pose-Perturbed Radiographic Alignment & Cobb/HKA Mensuration | ◈ S-PUB TRL 3 → 5 | 0.9027 AUROC Locked-Test Spinopelvic Sagittal Pathology (DH/SL vs Normal) AUROC (n=124) 95% CI [0.8488, 0.9473] · vs Single-Angle Radiographic Mensuration Baseline (Pelvic Incidence Only) 0.7374 AUROC | 86 | 94 | ✓ PASS MFDS Orthopedic Radiological CADm / Mensuration SaMD Guideline (Sub-degree Repeatability) |
| W2 · 13-2 p.75–77 | High-Risk Pregnancy & Intrapartum Fetal SaMD Uteroplacental Oxygen Transport Simulator & Real 552-Delivery CTU-UHB Intrapartum CTG Predictor | ◈ S-PUB TRL 3 → 5 | 0.6376 AUROC CTU-UHB Locked-Test Pre-Delivery Metabolic Distress AUROC (n=136) 95% CI [0.5265, 0.7391] · vs Maternal Age Alone Baseline 0.5076 AUROC | 84 | 95 | ✓ PASS MFDS Obstetric Maternal-Fetal Monitoring SaMD Performance & IEC 62366-1 Usability Formative Test |
| W2 · 11-1 [3-6] p.61–64 | Wearable Patch ECG Risk SaMD 3D Cardiac Dipole Patch-ECG Simulator & Real 48-Record MIT-BIH Ambulatory Arrhythmia Detector | ◈ S-PUB TRL 3 → 5 | 0.9493 AUROC MIT-BIH DS2 Patient-Disjoint Ventricular Ectopy Detection AUROC (n=330) 95% CI [0.9228, 0.9733] · vs Naive Fixed-RR (<600 ms) Threshold Baseline 0.8702 AUROC | 85 | 94 | ✓ PASS ANSI/AAMI EC57 Arrhythmia Algorithm Beat/Rhythm Reporting & MFDS Wearable ECG SaMD Review |
| W2 · 11-1 [6-1] p.61–64 | ICU Sepsis-ARDS Severity & Prognosis Multi-Compartment Pulmonary V/Q Shunt Ventilator Twin & Real MIMIC-IV ICU Cohort Stratifier | ◈ S-PUB TRL 3 → 5 | 0.7442 AUROC MIMIC-IV First-24h Subject-Locked ICU Deterioration AUROC (n=66) 95% CI [0.6057, 0.8615] · vs Single-Vital Admission Shock Index (HR/SBP) 0.6552 AUROC | 85 | 93 | ✓ PASS KR CDI / HL7 FHIR ICU Vital-Sign Streaming Interoperability Conformance |
| W3 · 11-1 [3-1] p.61–64 | Aortic Dissection TEVAR Planning Pulsatile Bifurcated True/False-Lumen Hemodynamic Solver & Virtual TEVAR Entry-Closure Planner | ◈ S-SIM TRL 3 → 5 | 0.8269 AUROC Late Aortic Expansion Risk Stratification AUROC (Locked n=240) (n=240) 95% CI [0.7721, 0.8746] · vs Conventional Max Aortic Diameter >= 40 mm Guideline 0.5496 AUROC | 84 | 94 | ✓ PASS 4D-Flow Phase-Contrast MRI / CTA Centerline Concordance Benchmark |
| W3 · 11-1 [6-3] p.61–64 | IIP / IPF Multi-Omics & DP-Synth Cross-Cohort IIP/IPF Lung Transcriptome Classifier (GSE32537 → GSE24206) & Privacy-Preserving Synth Engine | ◈ S-PUB TRL 3 → 5 | 0.9529 AUROC Cross-Cohort Locked & External Lung Transcriptome AUROC (n=77) (n=77) 95% CI [0.8983, 0.9925] · vs Single-Locus MUC5B Transcript Expression Baseline 0.8701 AUROC | 85 | 93 | ✓ PASS KHIDI / PIPC Healthcare Pseudonymized & Synthetic Genomic Data Adequacy Review |
| W3 · 16-3 p.88–90 | Dementia Longitudinal MRI & ARIA Risk OASIS-2 373-Visit Longitudinal MRI Progression Ranker & T2*-GRE ARIA Scanner-Shift Simulator | ◈ S-PUB TRL 5 → 8 (Solo Ceiling TRL 5) | 0.732 AUROC Subject-Locked Longitudinal MRI Dementia Status AUROC (n=72 Visits / 31 Subjects) (n=72) 95% CI [0.6015, 0.8486] · vs Chronological Age-Only Clinical Baseline (Age-Matched Cohort) 0.5834 AUROC | 80 | 92 | ✓ PASS MFDS Pivotal Multi-Center Clinical Confirmation Trial Required for TRL 7–8 Commercial Approval |
| W4 · 18-3 [분야 2] p.101–103 | Wrong-Site / Wrong-Patient Surgical Prevention FHIR × DICOM × Surgical Consent Cross-Reconciler Across 2,400 Fault-Injected Scenarios + Cholec80 | ◈ S-PUB Hospital Safety System | 97.58 % Multi-Modal Surgical Error Detection Accuracy (n=2400) 95% CI [96.89, 98.13] · vs Surface String-Match & Unadjusted 24h Washout Baseline 58.58 % | 84 | 94 | ✓ PASS Operating Room PACS / EMR / Barcode Wristband On-Premise Hospital Living-Lab Pilot |
| W4 · 18-2 [분야 2] p.101–103 | Automated Dispensing & MFDS DUR Audit ePillID 3,728-Image 5-Fold Benchmark + Translucent Pouch Glare Simulator + Korean MFDS DUR Kernel | ◈ S-PUB Hospital Pharmacy Verification | 99.69 % Dispensing & MFDS DUR Hazard Interception Rate (n=320) 95% CI [98.25, 99.94] · vs Color-Shape Appearance-Only ATC Camera Baseline (No Imprint / No DUR) 87.19 % | 82 | 93 | ✓ PASS Korean ATC (Automated Tablet Dispensing & Packaging) Hardware Optical Rig Calibration |
| W4 · 5-1 p.35–37 | Structure-Based AI Drug + Zero-Custody CRO Real D3R GC4 BACE1/CatS Affinity Engine, Zwanzig FEP Cycle Closure & Zero-Physical-Custody CRO Bridge | ◈ S-EXT TRL 3 → 4 | 0.5033 r D3R GC4 Out-of-Sample ΔG_bind Pearson Correlation (n=73) (n=73) 95% CI [0.2312, 0.711] · vs Molecular-Weight-Only Null Heuristic (-MW Across 73 Ligands) 0.047 r | 82 | 94 | ✓ PASS Fee-for-Service Dispatch to ISO-17025 / MFDS-GLP External CRO (Zero Sponsor Lab License Required) |