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Pressure Display Box: This product is intended for use in displaying line pressures during cardiopulmonary bypass surgery.
DLP® Disposable Pressure Display Set: This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products.

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The provided document is a 510(k) summary for a medical device called the "Pressure Display Box" and "DLP® Disposable Pressure Display Set." This submission DOES NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any comparative effectiveness studies.

The document explicitly states:

• "No modifications have been made to the Devices as a result of this change. This submission is a result of a change to the labeling. The devices operating principle and technological characteristics are remaining the same."
• "The modifications to the Pressure Display Box and the DLP® Disposable Pressure Display Set described in this submission result in a substantially equivalent device because the fundamental scientific technology and the intended use are unchanged since the proposed labeling change."

This indicates that the submission is for a labeling change to an already cleared device (K852232) and not for a new device or significant modification that would require new performance studies to demonstrate safety and effectiveness. Therefore, the requested information regarding acceptance criteria and performance studies is not present in the provided text.

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