Search Results

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 a cardiopulmonary bypass pump speed controller. It 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 provided text does not contain specific acceptance criteria or an in-depth study description with performance metrics for the Bio-Console® 560. Instead, it describes a 510(k) premarket notification for a Class II medical device, the Bio-Console® 560, a cardiopulmonary bypass pump speed controller. The submission aims to demonstrate substantial equivalence to previously marketed predicate devices (Bio-Console® 550 and Bio-Console® 550M).

The key takeaway is that the manufacturer performed functional, hardware, and software testing to establish the device's performance characteristics. However, the details of these tests and the specific quantitative acceptance criteria and results are not provided in this summary.

Therefore, I cannot complete the table or answer most of the specific questions as the information is not present in the provided text.

Here's an assessment based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified.
• Data Provenance: Not specified, but implied to be from internal testing by the manufacturer (Medtronic Perfusion Systems). It is not stated whether it was retrospective or prospective, or the country of origin of the data.

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

• This is not applicable as the device is a pump speed controller, and the "ground truth" would likely be based on engineering specifications and measurement standards, not expert clinical interpretation.

4. Adjudication method for the test set

• Not applicable for this type of device testing.

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 hardware speed controller, not an AI-assisted diagnostic or interpretative system.

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

• The performance assessment likely focused on the device's standalone functional performance, as it's a pump speed controller. However, specific details of "standalone" testing are not provided beyond "functional, hardware and software testing."

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

• The "ground truth" for a device like this would typically involve engineering specifications, calibration standards, and established metrics for pump performance (e.g., flow rate, pressure, RPM accuracy). The document does not specify these details.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would require a "training set" in the conventional sense. The "training" here refers to the engineering design and development process.

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

• Not applicable. As above, this is not an AI/machine learning device.

Summary of available information:

The 510(k) summary states that "Functional, hardware and software testing was used to establish the performance characteristic of the modifications of this device from previously marketed devices." The conclusion drawn is that the Bio-Console® 560 is "substantially equivalent to the predicate devices based upon design, test results, and indications for use." This implies that the testing performed demonstrated performance comparable to the predicate devices, meeting the requirements for substantial equivalence, but the specific details of these tests and their numerical outputs are not included in this document.

Ask a specific question about this device