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The Stockert S3 Mast Pump is a modular component of the Stockert S3 Perfusion System. The S3 Mast Pump is intended to provide speed controlled pumping of blood through the cardiopulmonary bypass circuit for durations of normally six hours or less, left ventricular venting, cardiotomy suction, or the administration of cardioplegia solution, when used by a qualified perfusionsist who is experienced in the operation of the S3 System.

The Stockert S3 (cardiopulmonary bypass) Mast Pump Module is intended for use during cardiopulmonary bypass surgery. The S3 Mast Pump Module is a component of the Stockert S3 Perfusion System, and is intended to provide speed controlled pumping of fluid through the cardiopulmonary bypass circuit, left ventricular venting, cardiotomy suction, or the administration of cardioplegia solution. The predicate and predecessor device to the S3 Mast Pump Module is the S3 Double Head Pump Module. The S3 Mast Pump has the same double head pump design and intended use as the S3 Double Head Pump Module(K955038). The basic difference between these two double head pumps is that for the Mast Pump, the pump heads are mounted on the mast of an S3 Mast Pump Extension Unit, and the control/operating unit is placed on a swivel plate on the console, whereas for the standard 69 double head pump module, the control unit is mounted directly over the pump theads and the entire module is installed on the S3 Console Base. The Mast Pump configuration enables the perfusionist to position the pump heads in close proximity to the patient, thus reducing the length of tubing required for the extracorporeal blood circuit and the associated priming volume required. This option is useful in clinical situations where it is important to minimize the amount of tubing in the circuit, e.g. infant perfusion.

The provided 510(k) summary for the Stöckert S3 Perfusion System Mast Pump Module does not include acceptance criteria or a study demonstrating device performance against such criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (S3 Double Head Pump Module) and outlines the device's description, intended use, and conformity to general safety standards (IEC 601, IEC 62a, and UL 544).

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance from the provided text.

Here's why the requested information isn't present:

• No Acceptance Criteria: The document does not define specific performance metrics, thresholds, or pass/fail criteria for the device.
• No Performance Study Details: While it mentions "extensive testing results characterizing device performance and software verification and validation," it does not provide any details about these studies, such as:
  • The specific tests performed.
  • The results of those tests.
  • The methodologies used.
  • Any comparison to acceptance criteria.
  • Sample sizes, ground truth establishment, or expert involvement.

In summary, the provided text describes the device and its regulatory status, but lacks the detailed performance study information required to answer your specific questions.

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