(44 days)
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 is an extracorporeal blood pumping console consisting of a Base Unit with a display and a User Interface (touch screen) with integrated flow control knob. In order to perform its intended function, the Bio-Console 560 is compatible with the Medtronic External Drive Motor, disposable Centrifugal Pump, Flow Transducer with disposable Insert, and Emergency Handcrank.
The provided text is a 510(k) summary for the Medtronic Bio-Console® 560. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on minor software modifications and provides no information about a clinical study, acceptance criteria, or performance data for the device. The "Test Data" section explicitly states: "Software verification and validation testing confirms that the function of the Bio-Console 560 and its software-controlled functional characteristics are substantially equivalent to the predicate device. All test data obtained satisfied the documented product and performance specifications." This indicates that the assessment was based on engineering and software verification, not clinical performance with human data.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, and ground truth establishment cannot be extracted from the provided text. The device is a "cardiopulmonary bypass pump speed control," which is a piece of medical equipment, not an AI/ML algorithm that predicts or analyzes medical data and thus does not typically involve the kinds of studies described in your request (e.g., MRMC studies, standalone AI performance).
To directly answer your specific points based only on the provided text, without making assumptions:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of clinical performance metrics. The document implies that the acceptance criteria were based on software verification and validation satisfying "documented product and performance specifications" for substantial equivalence to the predicate device.
- Reported Device Performance: Not reported in clinical terms. The document states "All test data obtained satisfied the documented product and performance specifications," but these specifications and the test results are not detailed.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not applicable/not provided. No clinical test set involving patient data is mentioned. The testing focused on software verification and validation.
- Data Provenance: Not applicable/not provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/not provided. No clinical ground truth was established as no clinical study is described. The "ground truth" for software validation would be adherence to design specifications, which is typically assessed by engineers and testers.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/not provided.
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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:
- No MRMC study was done or mentioned. This device is not an AI diagnostic or assistance tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of typical AI device evaluation. The "software verification and validation testing" could be considered an "algorithm only" test for the embedded control software, but it's not a standalone diagnostic algorithm in the sense of modern AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the software modifications would be the functional requirements and design specifications of the device.
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The sample size for the training set:
- Not applicable/not provided. This is not an AI/ML device that requires a training set of data.
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How the ground truth for the training set was established:
- Not applicable/not provided.
§ 870.4380 Cardiopulmonary bypass pump speed control.
(a)
Identification. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.(b)
Classification. Class II (performance standards).