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The Century Perfusion System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

The Century Perfusion System is a modular system, like the Stöckert S5 System, consisting of a console base with peristaltic pumps, monitors, displays, controls, and user interfaces.

The provided text describes a 510(k) premarket notification for the Century Perfusion System, demonstrating its substantial equivalence to predicate devices (Stöckert S5 System and COBE Century Perfusion Pump). The document primarily focuses on engineering specifications, comparisons, and adherence to various medical device standards. It does not contain information about acceptance criteria or a study proving device performance in the context of AI/ML-driven medical devices, as the Century Perfusion System is a mechanical pump and not an AI/ML device.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance (in the context of AI/ML).
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study and effect size.
• Stand-alone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set.
• How the ground truth for the training set was established.

The document states: "No clinical tests performed." and details non-clinical tests to prove safety and effectiveness through compliance with standards like IEC 60601-1, IEC 62366-1, ISO 14971, etc. It also discusses software validation for the device's control system, but this is for a general software safety classification (Class C) and not for AI/ML performance.

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