(b)(4).Evaluation summary: though the capsule was not received for evaluation, the study was received.Based on the data that was collected during the procedure, it was clear that the total time of study was 48 hours.The study started with normal ph value, and then there was a low reading below ph 4- this is typical of when a patient is lying down or eating, so these were deemed acceptable values.There was a portion of the graph where the ph value was missing.The root cause for the missing ph values could not be determined.A review of the device history record indicating that the product was released meeting finished product specifications.
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