CEPHX3D

K252538

Orca Dental AI , Ltd. · cleared 2026-03-05 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.8)
“CEPHX3D is a cloud-based software-as-a-service (SaaS) solution designed for the automated processing and visualization of dental and maxillofacial Cone Beam Computed Tomography (CBCT) data. The software utilizes deep learning algorithms to perform three-dimensional segmentation of key anatomical structures, including skeletal bone (mandible and maxilla), the full dentition, and the inferior alveolar nerve (IAN).”
Algorithmdeep learning algorithms, specifically 3D U-Net Convolutional Neural Networks (CNNs) optimized for volumetric medical imaging
source quote (p.8)
“The device utilizes deep learning algorithms, specifically 3D U-Net Convolutional Neural Networks (CNNs) optimized for volumetric medical imaging, to segment specific anatomical structures from DICOM datasets.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

n=30 cases

endpoints: mean Dice Similarity Coefficient (DSC); mean Root Mean Square (RMS) surface error; mean 95th percentile Hausdorff Distance (HD95)

Retrospective clinical

n=53 cases

endpoints: cases rated as "Clinically Acceptable"; Fleiss' Kappa scores for inter-rater reliability

Reported performance (5 observations)

diceas written: “Skeletal Bone - mean Dice Similarity Coefficient (DSC)”0.9827
source quote (p.13)
“Skeletal Bone: Achieved a mean Dice Similarity Coefficient (DSC) of 0.9827 and a mean Root Mean Square (RMS) surface error of 0.0623 mm.”
diceas written: “Dentition - mean Dice Similarity Coefficient (DSC)”0.9993
source quote (p.13)
“Dentition: Achieved a mean DSC of 0.9993 and a mean RMS of 0.0136 mm.”
diceas written: “Inferior Alveolar Nerve (IAN) - mean Dice Similarity Coefficient (DSC)”0.9861
source quote (p.13)
“Inferior Alveolar Nerve (IAN): Achieved a mean DSC of 0.9861 and a mean RMS of 0.1668 mm.”
agreement_kappaas written: “Fleiss' Kappa (Bone and Nerve models)”1CI Perfect Agreement
source quote (p.14)
“Inter-rater reliability analysis confirmed the robustness of these results, showing Fleiss' Kappa scores of 1.0 (Perfect Agreement) for bone and nerve models, and 0.80 (Strong Agreement) for dentition.”
agreement_kappaas written: “Fleiss' Kappa (Dentition)”0.8CI Strong Agreement
source quote (p.14)
“Inter-rater reliability analysis confirmed the robustness of these results, showing Fleiss' Kappa scores of 1.0 (Perfect Agreement) for bone and nerve models, and 0.80 (Strong Agreement) for dentition.”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K252538