Seaman Pro/Seaman

The Seaman PRO is an automated, point-of-care, in vitro diagnostic device for semen analysis performed by healthcare professionals. It consists of imaging hardware (light source, optics, USB camera) connected to a PC running AI-based software that quantifies sperm concentration, total and progressive motility, morphology, vitality, and pH to assess sperm quality in adult males.

The Seaman PRO uses a modular hardware configuration (camera + optics + PC with AI software) versus the predicate's integrated desktop analyzer. Both employ custom image analysis with machine learning for sperm detection, but the Seaman PRO's modular design does not impact functionality. The Seaman PRO additionally measures vitality (percentage live sperm), which is supplementary and does not change the core intended use.

Testing was designed per CLSI guidelines, WHO laboratory manual requirements, and ISO 23640:2015 standards. Non-clinical studies evaluated repeatability, reproducibility, linearity, limits of blank/detection/quantification, interference, sample volume effects, and environmental/hardware stability. Clinical testing compared the device against established reference procedures using 300 human semen samples.

Both devices are in vitro diagnostic systems for quantitative human semen analysis targeting similar point-of-care professional users. Core measurement parameters (sperm concentration, total/progressive motility, morphology, pH) are identical; vitality is an additional supplementary feature that does not raise new safety or effectiveness concerns. Optical imaging and AI-assisted image analysis technology is fundamentally equivalent, and clinical method comparison demonstrated strong agreement (correlation >0.90, regression slopes 0.90–1.10).