![]() ![]() The primary outcome measures were the level of agreement (%) and κ ( kappa) statistic between the standard-of-care colposcope and each Pocket Colposcope (Generation 3 and Generation 4).Ĭitation: Lam CT, Mueller J, Asma B, Asiedu M, Krieger MS, Chitalia R, et al. Corresponding pathology was obtained for all image pairs. The paired images were blinded by device, randomized, and sent to an expert physician who provided a diagnosis for each image. ![]() Specifically, paired images of cervices were collected from the standard-of-care colposcope and either the Generation 3 (n = 24 patients) or the Generation 4 (n = 32 patients) Pocket Colposcopes. A pilot clinical study was conducted to compare the Generation 3 and 4 Pocket Colposcopes to a standard-of-care colposcope (Leisegang Optik 2). Both systems were characterized with a series of bench tests to assess specular reflection, beam pattern uniformity, and image contrast. The reflector design (including the angle and height of the reflector sidewalls) was optimized through ray-tracing simulations. Cross-polarization (Generation 3 Pocket Colposcope) and a new reflector design (Generation 4 Pocket Colposcope) were used to reduce glare and improve contrast.
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