Collection of Training Data for LuminX Probe AI Models
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Dataset Completion - Successful acquisition of intraoral image dataset to allow AI training and validation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Informed consent.
- •Age ≥18 years.
- •Periodontal condition ranging from health/gingivitis to periodontitis (Stage I-IV).
排除标准
- •Participation in another study within 30 days that may interfere with data collection.
- •Pregnant or lactating women.
- •Recent tooth extraction or implant removal (less than 4 weeks pre-procedure)
- •Recent periodontal surgery (less than 4 weeks pre-procedure).
- •Currently undergoing chemotherapy, radiotherapy to the head/neck, or immunosuppressive therapy.
研究组 & 干预措施
LuminX Prob System
A trained dental professional will perform a scan of patient's mouth in order to collect images for the AI training
干预措施: LuminX Probe System (Device)
结局指标
主要结局
Dataset Completion - Successful acquisition of intraoral image dataset to allow AI training and validation
时间窗: 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.
次要结局
未报告次要终点