Guidelines for AI services use

This document describes what types of case are clinically supported or unsupported for our services: CBCT Segmentation, Optical Scan Segmentation (OSS) and CBCT-OS Fusion. These services are intended for treatment planning; this document guides partners with the integration of these AI services in their solutions. Technical requirements are described in the Appendix.

The products are available via a software programmable interface (API). The products are not suitable for applications where immediate support is required to sustain life.

Products

Below per product, an enumeration of conditions under which Promaton fully supports or does not support the processing of CBCT and optical scans.

CBCT-segmentation

Product description

This product automatically detects, separates, and generates 3D models of individual teeth, mandibular, and maxilla from CBCTs of a dentition.

Furthermore, it labels the lower and upper jaw, labels individual teeth with their corresponding FDI-number, and identifies the inferior alveolar nerve. Optionally, the product segments crowns and implants.

Case data

Supported

Patients of 15+ years old, female and male, worldwide countries, with mature teeth (secondary dentition).
A scan is received in a folder, as a single file, or as a stack of files, compressed with the gzip protocol
A folder that has a maximum size of 1 GB
A file(s) must originate from a Cone-Beam Computed Tomography (CBCT) scan and complies with the DICOM format
A scan contains 3D volumetric radiographic information pertaining to a single patient
A scan with a (small) gap between the upper and lower teeth; the mouth cannot be closed

Unsupported

Scans with metal scatters and large metal artifacts from facial surgery (implants excluded) and/or jaw implants
Syndromic patients
Certain partial or edentulous scans
Full head scans.
A scan with major scan artifacts (low contrast, motion, blur, etc.)
A scan that has foreign artifacts like wires, brackets, and metal markers for
Edentulous cases or observable gingiva

Appendix: Technical case data requirements

Supported technically

A scan’s slice and pixel spacing values must be above 0.01 mm
A scan must not have slices missing
Slice thickness should be uniform within a tolerance of 0.01mm
A scan must not have corrupted pixel data
A scan must have pixel data available i.e, cannot be empty.
A scan should have one of the following orientations:

[1.0, 0.0, 0.0, 0.0, 1.0, 0.0], # LPS
[-1.0, 0.0, 0.0, 0.0, 1.0, 0.0], # RPI
[1.0, 0.0, 0.0, 0.0, -1.0, 0.0], # LAI
[-1.0, 0.0, 0.0, 0.0, -1.0, 0.0], # RAS

Optical Scan Segmentation (OSS)

Product description

This product automatically detects, separates and generates 3D models of individual teeth and gingiva from optical scans of a dentition. Furthermore, it labels a scan as lower or upper jaw, labels individual teeth with its corresponding FDI-number and identifies the orientation of the scan (to know which direction is up for the teeth)*1

*1. If we do not have a large part of the gingiva, then especially the orientation and labeling will have a higher likelihood of errors.

Case data

Supported

A raw optical scan either from an intraoral scanner or lab scanner (for digitizing gypsum models)
A scan of a patient of 15+ years old with no deciduous teeth
A scan with a closed (artificially added) podium/base that has a flat base bottom surface
bigger than 17.70 cm2 and is not extruded out more than 4 cm
A scan that contains a single full arch with 6 or more teeth and all teeth must be fully
present
A scan that is partial with 4 or more teeth and all teeth must be fully present
The original (baseless) scan that contains at least 2 mm gingiva around teeth fully present
A scan that has no scan artifacts (holes, saliva, bubbles, warping, double edges, non-manifold vertices, consistent winding, etc.)
A scan that has no foreign artifacts (wires, brackets, preparations, engagers, etc.) 1 If we do not have a large part of the gingiva, then especially the orientation and labeling will have a higher likelihood of errors.
A scan that has no anomalies (broken or cracked teeth, abfractions, gum recessions, partially erupted teeth, deformed, excessive wear, etc.)

Unsupported

Certain partial scans and scans with supernumerary teeth.
A scan of an edentulous patient (2 or less teeth)
A scan that contains a single full arch with 3 or more teeth that are fully and/or partially present (i.e., broken or chipped teeth)
A scan with major scan artifacts (holes, saliva, bubbles, warping, double edges, non-manifold vertices, consistent winding, self intersections, etc.)
A scan that has foreign artifacts (wires, brackets, preparations, engagers etc.)
A scan of syndromic patients, patients with facial trauma, hyperdontia, major anomalies (e.g., abfractions and gum recessions), large bone defects or with previous facial surgery.
A scan that contains large scan remnants
An optical scan that is cleaned and/or repaired (i.e., holes are closed)

Appendix: Technical case data requirements

Supported technically

A scan that has between 500 and 200k vertices per tooth
A scan that has a maximum width/depth/height of 150 mm

Fusion

Product description

This product aligns and fuses the CBCT and OSS outputs into a single 3D representation, i.e. a virtual patient. Global alignment (a.k.a. the full dentition) is the basis for fusion without optimizing for individual tooth geometry. Bone structures and gingiva are aligned and single tooth structures consist of the OSS segmented crown and the CBCT segmented root stitched 1-2 mm below the gingiva margin line. When a case is supported, 95% of fused teeth do not have strange fusion artifacts and no transitional ridges - at the level of fused junction - sticking out (> 0.5 mm).

Case data

Supported

OSS and CBCT segmented crowns from scans that are supported, i.e. meeting the above-supported criteria and have correct inputs (e.g., correct FDI-numbering or no bad or wrong-segmented crown and root shapes) with a distance to average (DTA) between crowns of ≤ 1mm
Segmented optical and CBCT scans that meet the above-supported criteria and have the right inputs of a single full arch with 8 or more teeth and all teeth must be fully present

Unsupported

Scans with large discrepancies in segmentation, less than 8 teeth, incorrect inputs, or from non-Promaton suppliers.
OSS and CBCT segmented crowns from scans that meet the above supported criteria and have sufficiently correct (e.g., high accuracy FDI-numbering, a minimum of distorted or wrong segmented crown and root shapes, or discrepancy between segmented crowns) with a distance to average (DTA) between crowns of > 1mm
OSS and CBCT segmented crowns from scans where one or more meet the unsupported criteria and/or have insufficient inputs (e.g., low accuracy FDI-numbering, distorted segmented crown and root shapes, large discrepancy between segmented crowns, or artifacts/holes at the fusion junction) with a distance to average (DTA) between crowns of ≤ 1mm
Segmented optical and CBCT scans that meet the above supported criteria and have the right inputs of a single full arch with less than 4 teeth