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The Medtronic Performer CPB Advanced Extracorporeal Circulatory Support System is indicated for use up to 6 hours in the extracorporeal circulation of fluids for cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.

The centrifugal pump is indicated for use in pumping blood through an extracorporeal perfusion circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours).

The Performer CPB, is a next generation heart lung machine that integrates the primary functions and safety features needed to perform cardiopulmonary bypass and related circulatory support procedures. along with enhanced user conveniences, into a reduced sized instrument. The product is designed and manufactured by RanD S.r.l., Medolla, Italy for Medtronic and exclusively distributed by Medtronic Perfusion Systems.

It's initial configuration and features are optimized for use with the Medtronic Resting Heart System (K03170).

The key differences between the competitive heart lung machines and the Performer CPB arc:

• . A small foot print for the machine and pump's layout optimized (vertical orientation) for extracorporcal volume reduction. Collapsible feature for storage and easy transportation.
• . Electrically adjustable height and stability system.
• . Integrated Active Air Removal System.
• . A built in printer.
• Pre configured roller pump rotation . (unidirectional) and built in Handcrank in roller pumps for emergencies.
• . Integrated "Memory Card" for treatment data recording and software updates.
• . Integrated SatO2/Hct and Tcmperature monitoring system.
• . Cardioplegia delivery air detector with pump stop feed back.
• Selectable alcrt/alarm tones (including voice). .
• . Active Air removal with arterial flow servo control.
• . Predominant 'icon' based GUI.
• Independent status colored LED system (traffic . light style) for alerts and alarms in addition to the audio and visual set ups on the actual user interface screen.
• Roller pump cover sensors.
• . . Real time integrated parameters' trending.

This document describes a 510(k) submission for the Medtronic Performer CPB System, a heart-lung machine. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance criteria against predefined acceptance thresholds in the typical sense of a new medical AI device.

Therefore, many of the requested categories are not applicable to this submission. The document focuses on demonstrating equivalence to existing legally marketed predicate devices through performance testing and comparison of technological characteristics.

Here’s a breakdown of the information that can be extracted or deduced, along with an explanation of why other requested categories are not directly addressed:

1. Table of Acceptance Criteria and Reported Device Performance

This type of table is not present in the provided text. The submission aims to show "equivalence" rather than meeting pre-defined, quantitative acceptance criteria for novel performance claims. The performance data mentioned is for demonstrating this equivalence.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "performance data" and "comprehensive testing" but does not detail the number of units or test subjects involved in these tests.
• Data Provenance (country of origin, retrospective/prospective): Not explicitly stated. The manufacturing site is RanD S.r.l., Medolla (MO) – ITALY. The testing would likely have been conducted by or for the manufacturer. The nature (retrospective/prospective) of the performance data tests is not specified.

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

Not applicable. For a device like a heart-lung machine, "ground truth" is not established by expert consensus on interpretations but rather by physical measurements and engineering validation against established standards or predicate device performance. The performance data would involve technical measurements and comparisons.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is typically relevant for studies involving human interpretation (e.g., radiology images) where expert consensus resolves discrepancies. For a mechanical medical device, direct measurements and engineering analysis are performed.

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 is not an AI-assisted diagnostic or interpretive device. It is a cardiopulmonary bypass system.

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

Not applicable. This is a physical medical device, not an algorithm. Performance tests would inherently be "standalone" in the sense that the device's functional outputs are measured, but it's not an "algorithm only" study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not explicitly stated using these terms. For a physical device, "ground truth" for performance would be established through objective physical measurements, engineering specifications, and comparison against established performance benchmarks of predicate devices. For example, air handling capabilities would be measured using technical equipment and compared to the predicate's measured capabilities or accepted standards.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that requires a training set.

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

Not applicable. This device is not an AI/ML model.

In summary, this 510(k) submission focuses on demonstrating substantial equivalence of a physical medical device to already approved predicate devices through performance data and comparison of technological characteristics, rather than establishing performance against novel statistical acceptance criteria typical of AI/ML or diagnostic devices.

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