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P3T™ Abdomen automates the calculation of individual contrast injection protocols, based on patient characteristics and contrast concentration. P3T™ Abdomen is a software application for use on a laptop computer.

P3T™ Abdomen is indicated for use with CT angiography of abdominal organs (i.e., liver, pancreas, kidneys).

Similar to the predicate device, P3T™ Abdomen automates the calculation of individual contrast injection protocols for CT imaging, based on patient characteristics and contrast concentration. Different from the predicate device, P3T™ Abdomen is intended for imaging of the abdominal region and operates on a laptop computer in the control room.

The Stellant Injector System operating software has not been modified for P3T™ Abdomen. The injector system, when used in conjunction with the P3T™ Abdomen laptop computer application, maintains the same intended use, same operational parameters, and same labeling. Every protocol generated by the P3T™ Abdomen laptop application must be manually entered into the injector. The Stellant Injector System user interface has not been modified for P3T Abdomen. The injector continues to enable modification or deletion of the protocol, and requires the user to approve and lock the protocol prior to injection. The practitioner always has the option of modifying or deleting the P3T™ Abdomen computed protocol.

This 510(k) submission describes the P3T™ Abdomen, a software application designed to automate the calculation of contrast injection protocols for CT angiography of abdominal organs. The submission is a comparison of this device to a predicate device, the P3T™ CardiacFlow, and as such, it does not contain the specific acceptance criteria or the study data that would demonstrate the device meets those criteria.

The document primarily focuses on establishing substantial equivalence to the predicate device by highlighting similarities and differences in intended use, features, and principles of operation.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.

The document is a regulatory submission for premarket notification, which typically focuses on demonstrating equivalence to a legally marketed predicate rather than providing detailed clinical study results and acceptance criteria in the same way a clinical trial publication would.

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