Estimated patient exposure: This section of PSUR shall provide the estimates of the size and nature of the population exposed to the medical device. Brief descriptions of the method used to estimate the subject exposure shall be provided in terms of, — (i) Cumulative and interval subject exposure in Clinical investigation; (ii) Cumulative and interval patient exposure from Marketing Experience in India; (iii) Cumulative and interval patient exposure from Marketing Experience from the rest of the world.