Data Collection for AI Training of Dental Prob
Conditions
Brief summary
The purpose of this study is to prospectively collect fit-for-purpose, representative intraoral optical data using the LuminX Probe system to support development and validation of AI-enabled LuminX Probe software functions (AI-DSF). The collected data will be used for model training, validation, and future performance monitoring, in alignment with Good Machine Learning Practice (GMLP) principles.
Detailed description
This study is observational and is not intended to evaluate the diagnostic performance or safety and effectiveness of LuminX Probe; rather, it focuses on generating high-quality images across clinically meaningful subgroups to support robust and unbiased AI model development. For the purpose of this data collection study, only part of the system will be in use, including the handpiece, camera and off the shelf FDA approved nylon cover, without the actual probe tip. Consented eligible subjects will undergo a set of intra-oral imaging using the LuminX Probe. A trained dental professional will perform a scan of patient's mouth in order to collect optical imaging data from LuminX Probe (images/video/3D scans), and metadata for machine learning (tooth, site, orientation, operator ID, etc.). Estimated procedure duration: \ 15 minutes. All data will go through a de-identification process prior to storage and processing, with no identifiable patient information collected. No follow-up visits are required.
Interventions
DEVICELuminX Probe System
Intraoral optical scan of patient's mouth in order to collect optical imaging data from LuminX Probe
Sponsors
LuminX
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective, multi-center, single-arm, open-label data collection study. Subjects undergo a single intraoral imaging session using the LuminX Probe handpiece (without probing tip) to collect optical imaging data for AI model training and validation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Signed Informed consent. 2. Age ≥18 years. 3. Periodontal condition ranging from health/gingivitis to periodontitis (Stage I-IV).
Exclusion criteria
1. Participation in another study within 30 days that may interfere with data collection. 2. Pregnant or lactating women. 3. Recent tooth extraction or implant removal (less than 4 weeks pre-procedure) 4. Recent periodontal surgery (less than 4 weeks pre-procedure). 5. Currently undergoing chemotherapy, radiotherapy to the head/neck, or immunosuppressive therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dataset Completion - Successful acquisition of intraoral image dataset to allow AI training and validation | Day 1 | The same intervention and same images are collected from all study participants. In order to allow diversity of data, the protocol has pre-defined enrollment targets to achieve a minimum representation of demographic and clinical subgroups, including periodontal disease stages I-IV, age bands, sex, and race/ethnicity, in alignment with Good Machine Learning Practice (GMLP) principles. |
Countries
United States
Outcome results
None listed