Search Results

The AFFINITY™ CP Centrifugal Blood Pump is used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours).

It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants).

The AFFINITY™ CP Centrifugal Blood Pump is driven by the External Drive Motor or the Emergency Handcrank.

The Medtronic AFFINITY CP Centrifugal Blood Pump is a sterile, single-use centrifugal blood pump. It is a non-invasive, nonpyrogenic device designed to move blood through the extracorporeal circuit by centrifugal force. The pump is the disposable portion of the pumping system and it is electromagnetically coupled to an instrument that monitors and displays the flow and pressure of the blood. Blood enters the inlet port of the pump, where a cone with impeller blades within the pump housing rotates and the blood is gently accelerated towards the outlet of the pump.

The AFFINITY CP Centrifugal Blood Pump can be driven through magnetic coupling by the following two devices:

• External Drive Motor (Model 560A)
• Emergency Handcrank (Model HC150A)

Here's an analysis of the acceptance criteria and study information based on the provided K100631 document. It's important to note that this document is a 510(k) summary for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial results for a novel AI device. Therefore, many of the requested points, particularly those related to AI algorithm performance (e.g., MRMC studies, training set details), may not be directly applicable or fully present in this type of submission.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical "acceptance criteria" in a table format. Instead, it describes general improvements and successful "verification and validation testing." The performance is compared qualitatively to the predicate device. For this submission, substantial equivalence to the predicate device is the primary acceptance criterion, demonstrated through comparative testing and design.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "verification and validation testing" and "validation testing under simulated conditions of use." However, it does not specify the sample size (e.g., number of pumps tested, number of simulated runs) for these tests. There's also no information provided regarding data provenance (country of origin, retrospective/prospective). This type of detail is often found in the full testing report, not typically in the 510(k) summary.

3. 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)

The document mentions "expert users" in the context of validation testing under simulated conditions. However, it does not specify the number of experts used or their qualifications.

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

The document does not describe any adjudication method for the test set.

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

The device is a mechanical blood pump, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

This is a mechanical device, so "standalone algorithm-only performance" is not applicable. Performance was assessed based on the physical and functional characteristics of the pump and its drive systems.

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

For this mechanical device, the "ground truth" for its performance would be established through:

• Engineering specifications and standards: For parameters like maximum pressure generation, flow rates, maximum speed, port strength, magnetic coupling force, noise generation, and prime volume.
• Laboratory measurements: For quantification of heat generation, priming volume, and hemolysis.
• Biocompatibility testing: To ensure safety when in contact with blood.
• Functional assessment by expert users: During simulated conditions of use.

There isn't a "ground truth" in the same sense as an AI diagnostic device (e.g., pathological diagnosis for an image analysis algorithm).

8. The sample size for the training set

This is a mechanical device, not an AI algorithm. Therefore, there is no training set in the context of machine learning. The device's design is based on engineering principles and previous device iterations (the predicate device), not on a data-driven training process.

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

As there is no training set for an AI algorithm (since this is a mechanical device), this question is not applicable.

Ask a specific question about this device