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The Rapid Transfer Blood Bag is intended for use as a blood evacuation and reinfusion device for shed mediastinal and pleural drainage when used in conjunction with the Pleur-evac Continuous Reinfusion Autotransfusion Systems.

The Rapid Transfer Blood Bag is a flexible vinyl bag with a rigid frame that can be expanded using an actuator handle to cause transfer of blood from a Continuous Reinfusion Autotransfusion System.

The provided text is a 510(k) summary for the "Rapid Transfer Blood Bag," a medical device. This document focuses on the regulatory submission process and the intended use of the device, rather than detailed performance studies or specific acceptance criteria with reported data.

Therefore, the document does not contain the information requested to comprehensively fill out the table regarding acceptance criteria and study details.

Here's a breakdown of what can be extracted and why other sections cannot be completed:

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

• Cannot be filled. The document does not specify quantitative acceptance criteria or report performance metrics (e.g., blood transfer rate, efficiency, mechanical strength, sterility, biocompatibility data from specific tests). It's a regulatory submission summarizing the device and its intended use, rather than a detailed study report.

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

• Cannot be filled. The document does not describe any specific testing, test set sample sizes, or data provenance.

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)

• Not applicable. This question pertains to studies involving expert review for ground truth establishment, typically for diagnostic or image-based devices. The Rapid Transfer Blood Bag is a device for fluid transfer, and its evaluation would not typically involve expert consensus on "ground truth" in this manner.

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

• Not applicable. See point 3.

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 not an AI/diagnostic software, so MRMC studies are irrelevant.

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

• Not applicable. This device is not an algorithm or AI.

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

• Not applicable. See point 3.

8. The sample size for the training set

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

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

• Not applicable. See point 8.

In summary, the provided document is a regulatory affairs submission (510(k) summary and FDA letter) focused on demonstrating substantial equivalence to predicate devices, rather than a detailed technical study report containing performance data and acceptance criteria.

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