LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer

The LensHooke X1 PRO and X1 PRO SE Semen Quality Analyzers are optical devices that employ image analysis and artificial intelligence to provide quantitative measurements of key semen parameters, including sperm concentration, motility, morphology, and pH, for male fertility assessment. These systems are designed for use with a specific test cassette, with the X1 PRO version for professional point-of-care settings and the X1 PRO SE for over-the-counter home use.

The LensHooke X1 PRO and X1 PRO SE Semen Quality Analyzers are optical in-vitro diagnostic devices designed for human semen analysis to evaluate male fertility. They provide quantitative measurements for sperm concentration (10^6 per ml), total motility (%), sperm morphology (normal forms, %), and pH value. The X1 PRO model, intended for healthcare professional settings, additionally differentiates between progressive and non-progressive motility. Both systems utilize the LensHooke Semen Test Cassette, a specialized microscopic slide, and operate by integrating optical design with image analysis and artificial intelligence image processing. The analyzers capture images via cameras; sperm concentration is determined by sperm unit density, motility by tracing sperm trajectories, and morphology by comparing head and tail percentages, while pH is assessed through chromatographic image analysis of pH paper. The systems include consumables such as the test cassette, quality control beads and reticles (LensHooke X QC Beads and Reticle), a liquefaction test cup (C-KUP), and cleaning wipes. Non-clinical testing evaluated repeatability, reproducibility, limit of blank/detection/quantitation, linearity, sample volume, operating conditions, and stability. Clinical studies included a system accuracy study and a lay-user performance study for the X1 PRO SE (over-the-counter model), which demonstrated that lay users could understand instructions and obtain accurate results compared to a reference method (SQA-V Analyzer) used by professionals. The devices are presented as tools for fertility evaluation but do not provide a comprehensive assessment of male fertility status; the X1 PRO SE is specified for single-person home use.

AI Regulatory Concerns

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• Q1. What are the specific Limits of Blank (LoB), Detection (LoD), and Quantitation (LoQ) for sperm concentration, motility percentages, morphology percentage, and pH value?; How does the artificial intelligence image processing algorithm differentiate between normal and abnormal sperm morphology, and what are its criteria for head and tail percentages?; What were the quantitative results and statistical significance of the repeatability and reproducibility studies across different operators and device units?; Can the device differentiate between progressive and non-progressive motility accurately in samples with very low or very high sperm concentrations?; How does the device's performance in lay-user hands for the X1 PRO SE model compare to results obtained by trained professionals using the X1 PRO model or the SQA-V reference method, particularly in terms of accuracy and precision for each parameter?