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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
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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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