CIRRUS HD-OCT User Manual 2660021169012 Rev. A 2017-12Appendix B-13Table B-12: Repeatability and Reproducibility of Area of RPE ElevationsThe repeatability and reproducibility SD and limits of the volume of RPE elevations are seenin Table B-13 below. The repeatability limit of volume measurements within the 3 mmcircle was higher than that of the 5 mm circle in the 200x200 scans (0.0327 and 0.0275mm3 respectively). For the 512x128 scan, the opposite was true, although the differencewas smaller (0.0206 and 0.0245 mm3 respectively). The reproducibility limit of volumemeasurements within the 3 mm circle was higher than that of the 5 mm circle in the200x200 scans (0.0341 and 0.0298 mm 3 respectively). For the 512x128 scan, thereproducibility limits for the 5 mm circle was higher than that of the 3 mm circle (0.0288vs. 0.0235 mm 3). The repeatability and reproducibility limits will affect the ability todetermine when measurements have changed due to a change in pathology as opposed torandom variability.Repeatability ReproducibilityRepeatabilitySD (mm 2)RepeatabilityLimita (mm 2)Reproducibility SD(mm 2)ReproducibilityLimitb (mm 2)CVc%200x200 Scan3mm Circle 0.1295 0.3626 0.1568 0.4389 10.1%5mm Circle 0.1012 0.2834 0.1455 0.4073 4.9%512x128 Scan3mm Circle 0.0837 0.2343 0.0998 0.2794 7.5%5mm Circle 0.1537 0.4304 0.1936 0.5422 9.6%a. Repeatability Limit is the upper 95% limit for the difference between repeated results. Per ISO 5725–1 and ISO 5725–6, Repeatability Limit = 2.8x Repeatability SD.b. Reproducibility Limit is the upper 95% limit calculated for the difference between individual measurements using different operators and instru-ments. Per ISO 5725–1 and ISO 5725–6, Reproducibility Limit = 2.8 x Reproducibility SD.c. CV = Coefficient of variation = SD ÷ Mean.