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VivoSonic™ will be used during invasive medical diagnostic ultrasound imaging to couple sound waves between patient and medical imaging electronics and to lubricate the insertion and passage of imaging devices, such as ultrasound transducers and endoscopes.

VivoSonic™ is intended for use in conjunction with transcutaneous ultrasound image guided biopsy and aspiration, intraoperative ultrasound imaging, endocavity ultrasound imaging and opthalmic ultrasound imaging.

VivoSonic™ is unit dose packaged, sterilized and intended for use in all diagnostic ultrasound procedures which currently use and ultrasound coupling gel or fluid alone or in combination with a latex, non-latex, polyurethane or polyethylene transducer cover where sterility and/or in vivo biocompatibility are required.

VivoSonic™ is an in vivo biocompatible sterile ultrasound couplant and lubricant that couples or conducts ultrasound between the body and the ultrasound transducer and electronics.

The VivoSonic™ formulation is in vivo biocompatible with tissue and body fluids and is recognized as safe for oral administration (1)

This is a 510(k) Premarket Notification for the VivoSonic™ Diagnostic Ultrasound Imaging Coupling Media. This document does not contain information about the performance of an AI/ML device.

The provided text describes a medical device (ultrasound coupling media) and its intended use, and states that it is substantially equivalent to other legally marketed predicate devices. It covers regulatory information, device classification, and indications for use.

Therefore, I cannot extract the requested information about acceptance criteria, device performance, study details, ground truth establishment, or human-in-the-loop performance, as these topics are not present in the provided submission for this type of device.

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