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The Sorin Centrifugal Pump (CP5) is a cardiopulmonary bypass speed control device indicated for use exclusively with the Sorin Revolution®, for speedcontrolled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less.

The CP5 has been qualified only for typical durations of six hours or less, appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

The Sorin CP5 is intended for use as a component part of or optional accessory for the Sorin heart lung machine consoles and with the Stöckert Air Purge (APC) the Borin heads they System. The Sorin CP5 consists of the drive unit, a mounting receptacle for the Dystein. The Cretaining key, splash protection, and a 3-joint mast holder with fast clamp connector. It integrates the functional capabilities of the SCP, the SCP Plus, and the Sorin Pulse Mode Control within a single device.

The Sorin CP5 consists of hardware, firmware, and electronics that are used to drive the centrifugal pump for surgical procedures requiring cardiopulmonary bypass for typical durations of six (6) hours or less. The SCP drive unit uses magnetic coupling with the disposable centrifugal pump.

The Sorin CP5 with the loaded centrifugal pump recirculates the contents of the extracorporeal circuit during cardiopulmonary bypass.

The design, materials, and physical properties of the CP5 are essentially unchanged from that of the parent/predicate devices already reviewed and cleared by the FDA.

The provided text describes a 510(k) summary for the Sorin Centrifugal Pump (CP5). However, it explicitly states that no clinical testing and no comparative nonclinical testing served as the basis for substantial equivalence. The summary focuses on technological characteristics compared to predicate devices and internal validation.

Therefore, the requested information regarding an acceptance criteria table, detailed study parameters, ground truth establishment, expert involvement, and MRMC studies cannot be extracted from the provided text, as such studies were not performed or are not reported.

Here's what can be extracted based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Testing of the Sorin Centrifugal Pump (CPS) demonstrates that the CP5 fulfills prospectively defined performance criteria and meets user needs." However, the specific quantitative or qualitative acceptance criteria and the corresponding reported device performance values are not detailed in this summary.

2. Sample size used for the test set and the data provenance:

Not applicable. The document states: "No comparative nonclinical testing served as the basis for substantial equivalence." and "No clinical testing served as the basis for substantial equivalence." The testing performed involved "integration testing of hardware and firmware, functional testing, testing of organized (IEC 60601-1 including deviations for the US) and associated tooling, success (IEC 60601-1-2), and validation testing (simulated use and in use)." This describes internal validation, not a test set based on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no external test set with ground truth established by experts is described.

4. Adjudication method for the test set:

Not applicable, as no external test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a cardiopulmonary bypass centrifugal pump, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed or is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device is a hardware component (centrifugal pump) with firmware, not a standalone algorithm. Performance testing was internal validation of the hardware and firmware.

7. The type of ground truth used:

Not applicable in the context of clinical or diagnostic performance. The "ground truth" for the internal validation would be the design specifications and expected functional behavior.

8. The sample size for the training set:

Not applicable, as this is not an AI/machine learning device with a training set.

9. How the ground truth for the training set was established:

Not applicable, as this is not an AI/machine learning device with a training set.

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