(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 evident that the study duration was 95.48 hours.The study started with normal ph value; after 72 hours, the ph dropped below ph 2 and then then ph raised above ph 8 with missing values.This indicates that the capsule detached early, continued to the stomach which has a lower ph and then to the bowel, confirming the high ph.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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