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The COBE Century™ Precision Blood Pump is intended for use in cardiopulmonary surgical procedures requiring pumping of fluids in an extracorporeal circuit for periods up to 6 hours.

The COBE Century Perfusion Pump is the principal component of the COBE Century Perfusion System. It is a peristaltic-type roller pump that functions by tube-occluding rollers that move along a piece of tubing. As the pump head rotates, the rollers draw fluid through the tubing. Pumped fluids are contained within the tubing and have no contact with the pump. The pump has positive displacement over a wide range of flow rates and delivery pressures.

The COBE Century Perfusion Pump consists of:

• a front panel containing displays and operational switches
• a pump head with the roller pump mechanism and shields
• a chassis containing control cards, a power supply, and connectors for external devices

Here's a breakdown of the acceptance criteria and study information for the COBE Century Perfusion Pump, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified. The document states "every system requirement was addressed by a corresponding test or tests," implying a comprehensive test set was used, but the quantity of units tested is not provided.
• Data Provenance: The testing was conducted by COBE Cardiovascular, Inc. and is described as "system test level" validation. This is retrospective (performed by the manufacturer to validate their design). The country of origin is USA (Arvada, CO), as per the manufacturer's address.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not applicable. The ground truth for functional and user interface specifications is typically established through engineering design documents and industry standards, not by human expert consensus for a mechanical device like a pump.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. For functional specifications, the device either passes or fails the defined requirements. There's no mention of a human adjudication process for interpreting test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where human interpretation is a key component. This device is a mechanical pump.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Study: Yes, the testing described is a standalone performance study of the device's functional and user interface specifications, without human real-time intervention as part of the performance evaluation.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth was established by engineering design specifications and functional requirements for the device, including:
  • Functional operation (e.g., flow rates, speed accuracy, overspeed protection).
  • User interface behavior (e.g., display accuracy, switch response).

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This device is a mechanical pump with software, not a machine learning model that requires a "training set" in the typical sense of AI/ML. The "training" for the design would refer to the engineering and development cycles that led to the final specifications.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable in the context of AI/ML. The "ground truth" for the device's design and development comes from established engineering principles, industry standards for perfusion pumps, regulatory requirements, and the functional specifications derived from the intended use and predicate device characteristics.

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