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The SMARXT® BMR1900™ Closed Venous Reservoir Bag is intended to be used in cardiac surgical procedures requiring extracorporeal support for periods of up to six hours.

The SMARxT BMR1900 Closed Venous Reservoir Bag is a sterile device with a non-pyrogenic fluid pathway, for single use only, and is not intended to be resterilized by the user. The device is a soft-shelled blood reservoir designed for use in cardiopulmonary bypass surgery for periods up to six hours. The SMARxT BMR1900 can be operated at flow rates up to 6 liters per minute. The maximum operating volume is 1900 mL. The minimum operating volume is 300 mL. The SMARxT BMR1900 has a blood inlet port with an integral cardiotomy inlet on one side of the bag and a blood outlet port on the opposite side of the bag. Integral to the blood inlet port are connectors for measuring the temperature and saturation/hematocrit of the incoming blood using external monitoring equipment. The top edge of the bag has a dual four-way stopcock assembly that is used to purge air from the bag. The stopcock assembly may also be used for the administration of drugs or other solutions, as needed during the cardiopulmonary bypass procedure. Blood enters the bag through the inlet port and passes through a polyester screen filter before exiting the bag through the outlet port. The purpose of the filter is to facilitate the removal of large air bubbles from the blood.

The provided text is a 510(k) summary for the SMARxT® BMR1900™ Closed Venous Reservoir Bag. This document focuses on demonstrating substantial equivalence to a predicate device through a comparison of physical characteristics and in-vitro test data. It does not describe a study involving "acceptance criteria" for an AI-powered device, "reported device performance" in the context of diagnostic accuracy, "sample sizes for test or training sets," "expert ground truth establishment," or an "MRMC comparative effectiveness study."

Therefore, I cannot fulfill the request for information regarding acceptance criteria and studies proving the device meets them in the context of an AI/ML device. The document describes a traditional medical device submission.

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