X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application

The X100HT with Full Field Peripheral Blood Smear (PBS) Application is an in vitro diagnostic device that automates the analysis of peripheral blood smears by locating and displaying high-resolution digital images of blood cells, thereby assisting qualified technologists in performing WBC differentials, RBC morphology evaluations, and platelet estimations. It utilizes an automated slide loader, advanced image acquisition under varied illumination conditions, and artificial neural networks for initial cell classification and counting, with results requiring review and confirmation by a trained user.

The X100HT with Full Field Peripheral Blood Smear (PBS) Application is an automated system designed for in vitro diagnostic use by qualified laboratory professionals to analyze peripheral blood smears. It automates the process of locating, capturing, and displaying high-resolution digital images of white blood cells (WBCs), red blood cells (RBCs), and platelets from fixed and stained slides. The system features an integrated Slide Loader that automatically applies mounting media and coverslips and manages the loading of up to 30 slides in three cassettes, significantly enhancing workflow efficiency. Users are then assisted in conducting WBC differential counts, RBC morphology evaluations, and platelet estimations based on the images and initial analytical suggestions provided by the device. Operationally, the X100HT employs fully automated scanning utilizing multiple illumination conditions to reconstruct 100X magnification equivalent images without the need for immersion oil. For WBC analysis, it uses a battlement pattern for systematic cell counting and leverages deterministic artificial neural networks (ANNs) to pre-classify WBCs into eighteen distinct categories; these automated suggestions are then reviewed, confirmed, or reclassified by the technologist. Red blood cell morphology is evaluated by the user from overview images presented by the system, while platelet estimation is aided by automated detection and counting, with the final estimate subject to user review and potential modification. The device is intended for use by skilled personnel trained in hematological cell identification and the operation of the system.

AI Regulatory Concerns

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• Q1. How does the performance of the automated WBC classification by the ANN compare to manual expert review in terms of accuracy, precision, and speed across diverse patient populations, including those with rare or subtle hematological abnormalities?; What is the impact of the automated slide loading, mounting media application, and coverslipping process on sample integrity and image quality compared to traditional manual preparation, particularly for fragile cell types or low-volume samples?; Can the X100HT system be integrated with existing Laboratory Information Systems (LIS) for seamless data reporting and workflow management, and what are the specific data security and interoperability protocols supported?; What is the typical learning curve for laboratory technologists to achieve proficiency in using the X100HT, specifically in interpreting the AI-suggested classifications and making accurate modifications when necessary?; How do the 'plurality of illumination conditions' and the 'battlement pattern' for cell counting specifically enhance the accuracy and reliability of cell identification, differentiation, and morphological assessment compared to other automated microscopy techniques that may use different imaging or scanning strategies?