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The SenoRx ES 300 is an electrosurgical generator which is intended for general surgical procedures where electrosurgical cutting or coagulation of soft tissues is required.

The ES 300 Electrosurgical Generator is designed to cut and coagulate soft tissue. The ES 300 uses radio frequency (RF) energy to perform both cutting and coagulation, using RF handpieces.

The provided text describes a 510(k) summary for the SenoRx ES 300 Generator, an electrosurgical device. It outlines the device's intended use and compares it to predicate devices. However, the document does not contain information related to acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The provided text is a regulatory submission for a medical device that aims to demonstrate substantial equivalence to existing devices, not a study report detailing performance metrics against specific acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document primarily focuses on regulatory compliance and comparison to predicate devices, rather than detailed performance study results.

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