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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 nonerythrocytic 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.

The system includes disposable sets and accessories previously cleared by FDA in respective 510(k)'s.

This document is a 510(k) summary for the Fresenius Kabi CATSmart device, an autotransfusion system. It is a notification of intent to market a device that the manufacturer believes is substantially equivalent to legally marketed predicate devices.

The document does not contain detailed acceptance criteria for a study showing device performance. Instead, it describes general claims of substantial equivalence based on the device's design, materials, specifications, technological characteristics, and function being unchanged from previously cleared devices, and that manufacturing and sterilization methods at a new site remain the same.

Therefore, the requested information for acceptance criteria and a study proving the device meets them, including specific details about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, and training set details, is not available in the provided text.

The document specifically states: "No clinical data was required to support the changes described in this submission." This indicates that a study demonstrating performance against specific criteria was not conducted for this particular submission. The substantial equivalence is based on the device being inherently the same as a previously cleared one.

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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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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 packed 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. This version of CATSmart is also capable of perioperative separation of blood into PRP and PLS. 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. There is no change to system hardware or disposable sets described previously in K160735. The system includes the disposables AT1. AT3. ATS. ATY. ATO. ATR40 and ATR120. ATV-70 and ATV-180, ATF40 and ATF120. An ATV-F140 disposable set has been created (Class I 510(k) exempt). Also, PSQ disposable cleared under K971274 has also been qualified for use with the CATSmart System for the PSQ procedure. An additional wash program has been developed and added to the software to manage the PSO procedure.

The provided text describes the 510(k) summary for the Fresenius Kabi CATSmart Autotransfusion System, but it does not contain a detailed study section with acceptance criteria and device performance information.

Based on the available text, here's what can be inferred and what information is missing:

1. Table of acceptance criteria and the reported device performance:

This information is not explicitly stated in the provided text. The text mentions "in vitro blood quality studies in direct comparison to the predicate device C.A.T.S." and that "the validation tests passed for the new PSQ wash program on the CATSmart device with the PSQ set and AT3 tubing set." However, it does not detail the specific acceptance criteria (e.g., target ranges for red cell recovery, platelet removal, etc.) or the quantitative results from these studies.

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

This information is not provided. The text only mentions "in vitro blood quality studies."

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

This information is not provided. Given that this is an autotransfusion device primarily processing blood, the "ground truth" would likely be laboratory measurements of blood component quality, not expert consensus on images or diagnoses.

4. Adjudication method for the test set:

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for qualitative data (e.g., imaging interpretation), which is not the primary focus for validating an autotransfusion device.

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:

This is not applicable. An MRMC study is relevant for AI-powered diagnostic devices that assist human readers. The CATSmart system is an autotransfusion apparatus, not a diagnostic AI device.

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

This is not applicable. The CATSmart system itself is a device that processes blood, not an algorithm that performs a standalone diagnostic or interpretive function.

7. The type of ground truth used:

Based on the context of "in vitro blood quality studies," the ground truth likely involved laboratory measurements of various blood parameters (e.g., hematocrit, red cell recovery percentage, plasma volume, platelet count, etc.) obtained through standard analytical techniques.

8. The sample size for the training set:

This information is not provided. The device uses a continuous flow centrifuge principle, and typically such devices are validated through engineering and in vitro performance studies, rather than "training" on a dataset in the way a machine learning algorithm would be. The "new PSQ wash program" implies software, but the document does not specify if it involves machine learning.

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

This information is not provided and is likely not applicable in the context of this device as it's not a machine learning-based system that requires a "training set" in the conventional sense. The "ground truth" for evaluating the performance of the wash program would be established through laboratory analysis of the processed blood.

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The CATSmart (Continuous Autotransfusion System) device by Fresenius is an autotransfusion device indicated for the processing of autologous shed blood collected intraoperatively to obtain washed packed red blood cells for reinfusion.

The Fresenius Kabi CATSmart device is an intraoperative autotransfusion system for intraand/or postoperative processing of blood lost through surgery or trauma. The CATSmart device operates on the principle of a continuous flow centrifyge, comparable to continuous systems for hemapheresis which, for decades, have been widely used in blood banks. 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.

This document describes the CATSmart (Continuous Autotransfusion System) device and its substantial equivalence to its predicate device, C.A.T.S., as per the FDA 510(k) submission. Below is the requested information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that "All three wash programs (emergency wash program, low volume wash, smart wash) were tested. Overall it was judged that all validation tests were passed for all wash programs on the CATSmart device with the AT3 tubing set. A separate in vitro evaluation demonstrated that fat and heparin were almost completely removed from the processed blood."

Based on this, the implied acceptance criteria are the successful execution and performance of the device's core functions (blood washing programs) to a similar or acceptable level as the predicate device, particularly concerning the removal of plasma, non-erythrocytic cellular components, activated coagulation factors, fibrinolysis products, cell trauma products, anticoagulant, fat, and heparin, all leading to washed packed red blood cells suitable for reinfusion.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample size (e.g., number of blood samples or test runs) used for the in-vitro performance testing. It only mentions "in vitro blood quality studies."

There is no information about data provenance in terms of country of origin or whether it was retrospective or prospective. Given it was "in vitro blood quality studies," it would inherently be a prospective experimental setup.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The document states "Overall it was judged that all validation tests were passed," implying internal assessment. There is no mention of external experts or their qualifications for establishing ground truth for the in-vitro studies.

4. Adjudication Method

The document does not specify an adjudication method. The statement "Overall it was judged that all validation tests were passed" suggests an internal evaluation without detailing a formal adjudication process involving multiple parties.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not conducted. The CATSmart device is an autotransfusion apparatus, not an image-reading or diagnostic device that would involve human readers. Its primary function is blood processing, and the "hematocrit monitoring function" is specifically noted as "only used to monitor the wash process for informational purposes and is not intended for diagnostic or quality control purpose." Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The performance testing described is for the device as a whole, including its operational algorithms embedded in the software. The study focuses on the device's ability to process blood and remove impurities. While the document mentions a software update that includes the hematocrit function and touch screen control, it doesn't separate the "algorithm only" performance from the integrated system performance. However, since it's an automated system, its performance inherently represents an "algorithm only" or "device only" performance in its operational context. There is no human-in-the-loop interaction for the core blood processing function itself.

7. Type of Ground Truth Used

The ground truth for the device's performance (i.e., effective blood washing, removal of impurities) would have been established through analytical testing of the processed blood samples. This would likely involve laboratory measurements of various blood components, contaminants (e.g., plasma proteins, anticoagulants, fat, heparin), and red blood cell recovery, probably using established clinical laboratory standards and methods. The document mentions "in vitro blood quality studies," which supports this interpretation.

8. Sample Size for the Training Set

The document does not mention any "training set" or machine learning model development in the context of device performance testing. The main functional difference, the hematocrit monitoring, is an "additional technical feature" and its values are explicitly stated as "not a substitute for the hematocrit check on the product before it is reinfused... The sensors are not calibrated measuring instruments." This suggests that any algorithms related to hematocrit monitoring are rather simple estimations for informational display and are not based on complex machine learning requiring a "training set" in the typical sense. The device's core blood washing function is based on a continuous flow centrifuge, a well-established physical principle, rather than a learned algorithm needing an extensive training set.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned or implied for the core functions or the hematocrit monitoring (which is for informational purposes only), the establishment of ground truth for a training set is not applicable to the information provided.

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