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The C.A.T.S (Continuous Autotransfusion Svstem) by Frescruus 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 C.A.T.S is a continuous autotransfusion system working on the principle of a continuous flow centrifuge. In this continuous system, the blood to be processed passes through a separation chamber that can be divided into several compartments in which different steps of the autotransfusion process (i.e.; plasma separation, resuspension with saline and reconcentration) are performed simultaneously, creating a continuous flow of blood through the system. The C.A.T.S device is comprised of two major components: Reusable Autotransfusion Device (electromechanical microprocessor controlled device) and Disposable AT1 Autotransfusion Set.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Fresenius C.A.T.S Autotransfusion System Plasma Sequestration-Direct Draw Program and PSQ Set (Direct Draw).

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a full clinical study report designed to prove novel efficacy or safety with predefined criteria and detailed performance metrics. As such, some of the requested information (like specific effect sizes for MRMC studies, number of training set samples, or direct performance statistics for clinical outcomes) is not explicitly present.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not presented in a quantitative, pass/fail table as might be seen for a new device claiming specific performance metrics. Instead, the "acceptance criteria" are implied by demonstrating that the new components (PSQ Set (DD) and the direct draw software module) meet established standards and operate equivalently to predicate devices and the existing C.A.T.S system.

Study Details

Based on the provided K973378 510(k) Summary, here's what can be inferred about the "study" (which consists of multiple tests to support substantial equivalence):

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not explicitly stated in terms of patient numbers or blood samples. The testing appears to be primarily in vitro or bench testing on the device itself and its components (biocompatibility, structural integrity, software testing).
   • Data Provenance: Not specified. Given the nature of the tests (biocompatibility, structural integrity, software), it would likely be laboratory or bench test data, not necessarily country-specific clinical data. It is a retrospective compilation of test results.

2. Number of Experts used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts:

   • Number of Experts: Not applicable or not specified. This document describes testing against engineering standards (AAMI/ANSI) and internal software requirements, and biocompatibility standards (FDA/ISO). Ground truth, in the sense of clinical expert consensus for diagnosis or interpretation, is not relevant here as the device processes blood, it doesn't make clinical diagnoses.
   • Qualifications of Experts: The experts involved would be those performing the biocompatibility, materials, structural, and software engineering tests. Their specific titles or experience are not detailed.

3. Adjudication Method for the Test Set:

   • Method: Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers interpret medical images or data against a consensus ground truth. Here, the "test set" involves measurable physical and software performance against defined standards.

4. 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:

   • MRMC Study: No. This is not an AI/imaging device and an MRMC study is not relevant to its purpose. The device is an autotransfusion system, not an interpretive diagnostic tool.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Standalone Performance: The "standalone" performance here refers to the device's operational capabilities without direct human intervention once started. The software testing confirms the automated functions of the plasma sequestration direct draw program module meet requirements without human-in-the-loop comparison for efficacy. However, the device itself is an automated system for blood processing, so "standalone" performance in the AI context isn't directly applicable.

6. The Type of Ground Truth Used:

   • Ground Truth: The "ground truth" for the tests described are:
     • Biocompatibility: Compliance with FDA's modified ISO standards for biological evaluation of medical devices.
     • Structural Integrity: Compliance with AAMI/ANSI standards for autotransfusion devices.
     • Software Functionality: Meeting the requirements as set forth in the internal "Software Requirements Specification."
     • Shelf-life: Maintenance of biocompatibility, structural integrity, packaging integrity, and sterility over time, as tested according to internal protocols often based on industry standards.

7. The Sample Size for the Training Set:

   • Training Set Sample Size: Not applicable. This device is not an AI/machine learning device that requires a "training set" in the conventional sense. The "development" and "validation" would refer to engineering design, manufacturing, and testing processes.

8. How the Ground Truth for the Training Set Was Established:

   • Training Set Ground Truth: Not applicable, as there is no "training set" for an AI model. The "ground truth" for the device's engineering and performance validation comes from established engineering standards, material science principles, and software development best practices.

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The C.A.T.S (Continuous Autotransfusion System) by Fresenius 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 C.A.T.S is a continuous autotransfusion system working on the principle of a continuous flow centrifuge. In this continuous system, the blood to be processed passes through a separation chamber that can be divided into several compartments in which different steps of the autotransfusion process (i.e; plasma separation, resuspension with saline and reconcentration) are performed simultaneously, creating a continuous flow of blood through the system. The C.A.T.S device is comprised of two major components:
Reusable Autotransfusion Device: The C.A.T.S machine is an electromechanical a) microprocessor controlled device which incorporate the following major system components: the user display and function keys, centrifuge housing, centrifuge rotors; blood, packed red cell (PRC) and saline roller pumps; blood, saline and PRC sensors; leakage detector, and power supply unit. Additionally, the system includes the electronic components and system software which control and monitor the blood processing procedure.
b) Disposable AT1 Autotransfusion Set: This disposable set incorporates the continuous washing chamber, adapters for mounting the set into the C.A.T.S device, blood inlet line with stepped adapter, pump tubing, fluid lines; and the waste and reinfusion bags.
In order to perform plasma sequestration procedures a second disposable set is necessary:
c) PSQ Set: a single use, disposable set, includes bags for collection of plasma and platelet concentrates. Additionally, the PSQ Set includes lines/connections for connection to the whole blood bag and connection to the C.A.T.S AT 1 Autotransfusion Set.

The provided text covers the 510(k) summary for the Fresenius C.A.T.S Autotransfusion System. It details the device's intended use, features, and technological characteristics compared to predicate devices. The document focuses on demonstrating substantial equivalence to existing devices rather than defining specific acceptance criteria as quantitative thresholds for performance.

Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types for test and training sets) are not explicitly present in the provided text. The document refers to "studies" that were undertaken to demonstrate equivalence but does not provide the detailed methodology or results of these studies in the format requested.

However, I can extract information related to the studies that prove the device meets the general requirements for substantial equivalence to predicate devices.

Here's a breakdown of the information that can be extracted, and where fields are not explicitly addressed by the provided text, I will state that:

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

The document does not present a formal table of quantitative acceptance criteria with corresponding performance metrics. Instead, it concludes that the device performance for plasma sequestration is "substantially equivalent" to the predicate device and that the products prepared are "suitable for reinfusion." It also states that the PSQ Set satisfies AAMI/ANSI standards for structural integrity and that materials are suitable. Software requirements were also met.

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

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The text only mentions "studies have been undertaken."

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/Not specified. The assessment primarily relied on comparative performance metrics of the device with a predicate device and adherence to standards for materials and software, rather than expert-established ground truth on individual cases.

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

• Not applicable/Not specified.

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

• No, this is not an MRMC study. The device is a medical apparatus (autotransfusion system), not an AI-assisted diagnostic tool that would involve human readers interpreting AI output. The study compares the performance of the C.A.T.S device (hardware and software) in processing blood to a predicate device.

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

• Yes, the performance studies described are for the device (C.A.T.S system) functioning in a standalone manner for blood processing and plasma sequestration, comparing its outputs and operational characteristics to those of a predicate device. The device itself is an automated system where human intervention is primarily for setup and monitoring, not for interpreting results in a way that would require a human-in-the-loop performance study in the context of diagnostic AI.

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

• The ground truth for device performance appears to be established through:
  • Comparative performance data: Comparing key metrics (e.g., red cell, platelet, plasma recovery rates, quality of separated products) with a legally marketed predicate device (Medtronic Sequestra 1000).
  • Industry standards and FDA guidance: For biocompatibility (FDA's modified ISO standards), structural integrity (AAMI/ANSI standards), and software performance (Software Requirements Specification).
  • In vitro blood quality testing: To evaluate the safety and effectiveness of the plasma sequestration process parameters.

8. The sample size for the training set

• Not applicable/Not specified. This is a hardware/software system for blood processing, not a machine learning model that requires a distinct "training set" in the conventional sense. The "training" of the software would be its development and internal testing against specifications.

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

• Not applicable. The software's "ground truth" would be its adherence to the "Software Requirements Specification" which would have been established during the design and development phase. The document states, "the plasma sequestration module of the C.A.T.S system software has undergone testing to assure that system software requirements are met."

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