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The Medtronic centrifugal blood pumping system is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).

The Bio-Console® 560 Extracorporeal Blood Pumping Console is an electromechanical, software-controlled device intended to allow the user to control a Bio-Pump® or Affinity® CP centrifugal blood pump that is used to return the blood to the body of a patient on cardiopulmonary bypass. As part of the blood pumping circuit, the patient's blood is typically pumped through an oxygenator and a filter on its return path to the patient. The Bio-Console 560 is a reusable non-sterile device.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bio-Console® 560 Extracorporeal Blood Pumping Console:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the given document. The document mentions "software verification and validation testing" and "all test data obtained," but does not specify the sample size (e.g., number of test cases, number of runs) or the provenance (country of origin, retrospective/prospective nature) of the data used for this testing.

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

This information is not provided in the given document. The document describes a technical evaluation of software enhancements, not a study involving human experts establishing ground truth for a test set in the context of diagnostic interpretation or similar medical AI applications.

4. Adjudication Method for the Test Set

This information is not provided in the given document. As there's no mention of human experts establishing ground truth with potential disagreements, an adjudication method would not be relevant in this context.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for software enhancements to an existing device and focuses on substantial equivalence based on technical verification and validation, not on evaluating human performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance evaluation was implicitly done. The "software verification and validation testing" assessed the "software-controlled functional characteristics" of the device in isolation, confirming its function and substantial equivalence. The enhancements relate to internal software corrections and alarm tones, which are tested as part of the device's inherent functionality.

7. Type of Ground Truth Used

The "ground truth" for this submission appears to be derived from documented product and performance specifications and the functional characteristics of the predicate device. The testing aimed to confirm that the updated software met these pre-defined specifications and maintained performance equivalent to the predicate.

8. Sample Size for the Training Set

This information is not provided in the given document. The device is described as an electromechanical, software-controlled device, but there is no indication that it utilizes machine learning or AI that would require a "training set" in the conventional sense of an AI model. The software enhancements are described as corrections and updates to existing functionality.

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

This information is not provided in the given document. As no "training set" is mentioned or implied for a machine learning model, the establishment of ground truth for such a set is not applicable.

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