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The Waters Medical Systems (Waters Instruments, Inc.) RM3 Renal Preservation System is intended to be used to maintain kidneys for transplant.

The RM3 Renal Preservation System is a lightweight, transportable and self-contained renal preservation system, designed to support static monitoring and transportation of kidneys. The RM3 system control unit provides controlled kidney perfusion of hypothermic physiologic solutions, and monitors, displays, trends, and saves important perfusion parameters, including; perfusate flow temperature, rate and pressure, and resistance. The RM3 system control unit can be configured to signal an audio and visual alarm for user-selected limits, and print user-selected data and waveforms.

This K971571 document is a 510(k) summary for the RM3 Renal Preservation System-control unit. It describes the device, its intended use, and a comparison to a predicate device, but it does not contain details about specific acceptance criteria or an analytical study proving the device meets those criteria.

The document states:

• "Test results demonstrate that the RM3 control unit performance meets or exceeds the MOX-100 performance for each of the technologically different features."

However, it does not provide the acceptance criteria itself (e.g., specific thresholds for flow rate accuracy, temperature stability, pressure monitoring accuracy), nor does it describe the study design, sample sizes, or results that led to this conclusion.

Therefore, based on the provided text, I cannot answer the specific questions about acceptance criteria and study details. The document broadly states that the device's performance "meets or exceeds" the predicate device, but lacks the granular information required to complete the table and answer the study-related questions.

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