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The CATSmart System by Fresenius Kabi is an autotransfusion device indicated for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed red blood cells for reinfusion. Additionally, it can be used for perioperative separation of blood into Packed Red Cells (PRC), Plasma (PLS) and Platelet Rich Plasma (PRP).

The Fresenius Kabi CATSmart device is an intraoperative autotransfusion system for intra- and/or postoperative processing of blood lost through surgery or trauma.

The CATSmart device operates on the principle of a continuous flow centrifuge, comparable to continuous systems for hemapheresis which, for decades, have been widely used in blood banks.

In a typical CATSmart procedure, the shed blood, which is anticoagulated and collected in a sterile reservoir, is processed in a continuous washing process to obtain washed packed red cells for reinfusion to the patient. During this process all plasmatic and non-erythrocytic cellular components of the collected blood, and thus activated coagulation factors, products of fibrinolysis and cell trauma as well as the anticoagulant are removed. The packed red cells are collected in a reinfusion bag from which they can be reinfused to the patient via a transfusion set when needed.

In the Plasma Sequestration (PSQ) procedure, the patient's blood is separated into packed red cells (PRCs), plasma (PLS) and Platelet Rich Plasma (PRP). The principle of separation during plasma sequestration is the same as it is for autotransfusion i.e. physical separation of cellular components in the centrifugal field based on the differences in density and particle size.

The system includes disposable sets and accessories previously cleared by FDA.

The provided text describes updates to an autotransfusion device, the Fresenius Kabi CATSmart, specifically focusing on the addition of two new wash factors. The document, a 510(k) summary, aims to demonstrate substantial equivalence to a previously cleared version of the same device (predicate device K180831).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The text states that the performance of the two additional wash factors was tested by "in vitro studies." No specific sample size (e.g., number of blood samples, runs) is provided for these in vitro studies. The data provenance (country of origin, retrospective/prospective) is also not specified.

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

The document makes no mention of experts being used to establish ground truth for the test set. The evaluation relies on in vitro studies and system verification, which typically involve laboratory measurements against established standards for blood processing performance.

4. Adjudication method for the test set

No adjudication method is mentioned, as the evaluation is based on in vitro measurements and system verification, not on human interpretation or diagnosis requiring expert adjudication.

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 described is an autotransfusion apparatus, not an AI-assisted diagnostic imaging device that would involve human readers. Therefore, an MRMC comparative effectiveness study involving human readers and 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

The device itself is an automated system. The "in vitro studies" and "software verification" described are inherently standalone assessments of the device's functionality without human intervention in the processing itself, only in setting up and monitoring the tests.

7. The type of ground truth used

The ground truth for the performance of the wash factors would be based on laboratory measurements of parameters such as the purity of washed red blood cells, removal of plasma and cellular components, and retention of red blood cells. These measurements would be compared against established scientific and regulatory standards for autotransfusion devices. For the software changes, the ground truth would be defined by the expected functional behavior of the device as per its design specifications.

8. The sample size for the training set

The document does not describe a "training set" in the context of an AI or machine learning algorithm. The device is an automated blood processing system, not a learning algorithm. Therefore, this question is not applicable.

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

As there is no training set mentioned for this device, this question is not applicable. The device's functionality is based on its engineering design and validated through performance testing against pre-defined specifications.

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