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§Model Card

Orbital Trauma Planning Platform (Mimics-Romexis)

Real-time automated segmentation of orbital fractures to support diagnosis and surgical planning

Shhadeh A. · 2025 · Israel · doi:10.3390/diagnostics15080984
Open DOI
Segmentation Commercial API CT Regulator-cleared ⚑ FDA 510(k)
More attributes
Anatomy · OrbitAnatomy · Periorbital soft tissueConditions · Facial bone fractureConditions · orbital injuriesConditions · foreign body localizationSingle-centern = 53 patients · 53 CT images images
§01Overview

Brief overview

This study prospectively evaluates two FDA-cleared commercial AI segmentation engines — Materialise Mimics Viewer and Planmeca Romexis Smart Tool — for real-time orbital and maxillofacial fracture segmentation in 53 emergency-department CT cases. Both tools achieved Dice similarity of 0.92–0.93 against a semi-automated reference, with ~6× faster segmentation than the manual workflow. Expert readers rated clinical utility at 4.4/5. The work demonstrates that commercially available, regulator-cleared AI can already deliver clinically usable orbital segmentation; it does not characterize generalization, calibration, or subgroup performance, and the underlying model weights are proprietary.

§02Performance
Headline performance

Segmentation time ~10 min (AI) vs ~63 min (semi-automated); DSC 0.92–0.93; Jaccard 0.88–0.89; Hausdorff Distance ~0.92 mm; expert clinical utility score 4.4/5.

10
Segmentation time
0.92–0.93
DSC
0.88–0.89
Jaccard
Full metrics — as reported
Segmentation time ~10 min (AI) vs ~63 min (semi-automated); DSC 0.92–0.93; Jaccard 0.88–0.89; Hausdorff Distance ~0.92 mm; expert clinical utility score 4.4/5.
Calibration · Uncertainty
Not reported.
Bias · Fairness
Not reported.
§03Data & Validation
Study designProspective cohort
Center typeSingle-center
Patients53
Images / eyes53 CT images
SplitAll 53 cases used as the prospective evaluation cohort
Reporting frameworks None stated
Age rangeMean 37
Sex (% female)Not reported
Race / ethnicity reportedN
Subgroup performanceN
§04Deployment
Deployment maturity
  1. Concept
  2. Prototype
  3. Internal val.
  4. External val.
  5. Regulator
  6. Clinical
Regulatory status
FDA 510(k) NR
Artifacts & license
Code repository none
Pretrained weights none
Live demo
License Proprietary
§05Quality Review · APPRAISE-AI
Total score
29 /100 Low
ClinicalDataMethodRobust.Report.Repro.
Sub-domain scores
Clinical relevance 4/4 100%
Data quality 11/24 46%
Methodological conduct 4/20 20%
Robustness of results 1/20 5%
Reporting quality 8/12 67%
Reproducibility 1/20 5%
Why this score?

The APPRAISE-AI tool grades AI/ML medical studies across 24 items in 6 subdomains, scored independently by two reviewers. The total reflects the methodological transparency of the publication — not the underlying clinical value of the model.

How to read this: high scores in clinical relevance and reporting with low scores in methodological conduct, robustness, or reproducibility is the dominant pattern in ophthalmic AI today.

Quality bands: Low <40 · Moderate 40–59 · High 60–79 · Very High 80+. Most published ophthalmic AI sits in the Low–Moderate band; studies that break into High typically combine multi-center datasets, prospective evaluation, and open-source release.

§06Full Metadata
Citation & identification
Bibliographic record
Model IDoculoplastics_shhadeh_2025
Full author listDaoud, S., Redenski, I., Oren, D., Zoabi, A., Kablan, F., & Srouji, S.
JournalDiagnostics (Basel)
DOI10.3390/diagnostics15080984
ConditionsFacial bone fracture, orbital injuries, foreign body localization
Architecture
Model internals
Architecture familyCommercial API
Architecture detailFDA-approved commercial AI tools (Materialise Mimics Viewer; Planmeca Romexis Smart Tool).
Funding & conflicts
Disclosures
FundingDepartment of Oral and Maxillofacial Surgery, Galilee College of Dental Sciences, Galilee Medical Center, Nahariya 2210001, Israel
Conflicts of interestNo conflicts
Card lifecycle
Status, version, reviewers
Card statusPublished
Card versionv1.0.0
First added2026-04-28
Last reviewed2026-04-28
Reviewersattribution opt-in pending
Update history
Card changelog
  • 2026-04-28 initial publication (v1.0.0)
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