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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LuminX Prob System | Experimental | A trained dental professional will perform a scan of patient's mouth in order to collect images for the AI training |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LuminX Probe System | Device | Intraoral optical scan of patient's mouth in order to collect optical imaging data from LuminX Probe |
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| Measure | Description | Time Frame |
|---|---|---|
| Dataset Completion - Successful acquisition of intraoral image dataset to allow AI training and validation | 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. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zachi Lehr, MD | Contact | 972544418854 | zlehr@luminxsmile.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miles Madison, DDS Inc./ Beverly Hills Periodontal Institute | Beverly Hills | California | 90212 | United States |
Data collection study for AI model validation. Not sure it will be needed.
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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.
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| Modern Day Smiles | Tampa | Florida | 33607 | United States |
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| Cornerstone Dental Arts | Knoxville | Tennessee | 37923 | United States |
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