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Cerner iBus is a software application intended for use in the transportation, aggregation and derivation of data between medical devices and external systems used in a clinical setting for the purpose of automating data collection and clinical information management.

Cerner iBus is not intended to directly monitor, diagnose or treat patients or to be used in the prevention of a disease or condition, nor does Cerner iBus come into direct contact with patients.

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The provided text is a 510(k) summary for the Cerner CareAware™ iBus, an FDA medical device clearance letter. It describes the device's regulatory status and indications for use. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance and not on the technical and clinical validation studies that would involve such details.

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