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The Sorin C5 System is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six (6) hours or less, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the System.

The Sorin C5 System is a modification of the modular S5 System that comprises basic components and optional components. Optional components/accessories that have been cleared by the FDA for use as part of the S5 System are also compatible with the C5 · System.

The provided text is a 510(k) summary for the Sorin C5 System, a heart-lung machine. It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way one might for diagnostic software.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted because such a study, with a test set, ground truth, experts, and statistical analysis, typically applies to diagnostic or prognostic devices, not mechanical medical devices like a heart-lung machine.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

The document states:

• "Testing of the Sorin CS System has demonstrated that the System fulfills prospectively defined performance criteria and that the modified System meets user needs."

It does not provide a specific table of acceptance criteria or detailed performance metrics. The submission focuses on substantial equivalence to an existing predicate device (Stöckert S5 System), rather than establishing new performance benchmarks for a novel device. The performance testing is described as fulfilling "prospectively defined performance criteria," but these specific criteria and their fulfillment details are not included in the provided summary.

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

Not applicable/Not provided. The type of testing described (performance testing for a heart-lung machine) is likely mechanical and electrical functional testing, not a study involving patient data or test sets in the context of diagnostic algorithms.

3. Number of Experts, Qualifications, and Adjudication Method for the Test Set

Not applicable/Not provided. This type of information is relevant for studies involving human interpretation or consensus, such as AI for image analysis.

4. Adjudication Method for the Test Set

Not applicable/Not provided.

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

No. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. This device is a mechanical cardiopulmonary bypass system.

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

Not applicable. This device is a console with integrated roller pumps for cardiopulmonary bypass; it is not an algorithm that performs a task independently.

7. Type of Ground Truth Used

Not applicable/Not provided. The "ground truth" for a mechanical device like this would be its functional specifications and safety standards, rather than expert labels or pathology results.

8. Sample Size for the Training Set

Not applicable/Not provided. This concept applies to machine learning algorithms, not a heart-lung machine.

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

Not applicable/Not provided.

Summary of Relevant Information from the Provided Text:

• Acceptance Criteria Statement: "Testing of the Sorin CS System has demonstrated that the System fulfills prospectively defined performance criteria and that the modified System meets user needs." (Specific criteria and performance values are not detailed in this summary).
• Study Type: The submission focuses on establishing "substantial equivalence" of the Sorin C5 System to its predicate device, the Stöckert S5 System, based on "intended use, indication for use, operational characteristics, fundamental technological characteristics and performance specifications." This implied that the device met similar performance as the predicate, which was already cleared.
• Device Type: The Sorin C5 System is a Heart Lung Machine Console and integrated roller pumps, a mechanical medical device, not a diagnostic or AI-driven system. Therefore, many of the requested study elements are not applicable to this type of device submission.

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