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The Fresenius AT1 Autotransfusion Set is a component of the C.A.T.S Continuous Autotransfusion System that is an Autotranfusion device for the processing of autologous shed blood collected intraoperatively and postoperatively to obtain washed packed red blood cells for reinfusion.

The Fresenius Plasma Sequestration Set is a component of the C.A.T.S Continuous Autotransfusion System that is an Autotranfusion device 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 Reich Plasma (PRP).

The Fresenius Plasma Sequestration Direction Draw Set is a component of the C.A.T.S Continuous Autotransfusion System that is an Autotranfusion device 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 Reich Plasma (PRP).

The AT1 Autotransfusion Set includes the blood-washing chamber, adapters for mounting the set into the C.A.T.S. device, blood inlet line with stepped adapter, fluid lines; and the waste and reinfusion bags.

The Plasma Sequestration Set (PSQ) includes the bags required for collection of plasma and platelet rich plasma and the lines/connectors for connection to the whole blood bag and connection to the AT1 Autotransfusion Set.

The Plasma Sequestration Direct Draw Set (PSQ-DD) includes all the components included in the standard PSQ Set and additionally, a blood drawing/anticoagulant line assembly.

The C.A.T.S Continuous Autotransfusion System device is an autotransfusion device 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 Pack Red Cells (PRC), Plasma (PLS) and Platelet i Rich Plasma (PRP).

The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Fresenius Modified C.A.T.S Continuous Autotransfusion System, stating its substantial equivalence to a predicate device. It details the device description, intended use, and indicates its clearance by the FDA without providing specific performance metrics or study results.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method.
• MRMC comparative effectiveness study details or effect size.
• Standalone performance information.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

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The ATR 40 and ATR 120 Autotransfusion Reservoirs are indicated as autotransfusion reservoirs to collect, defoam, filter, and store blood prior to processing.

The Fresenius ATR 40 and ATR 120 are 3 liter blood collection reservoirs, with 40 or 120 micron filters respectively. They are used for the collection of blood lost intra- or postoperalively in surgical procedures. Collection is performed by vacuum suction via appropriate tubing systems e.g. double lumen suction lines for aspiration and simultaneous anticoagulation or drainage adapters connected to wound drains. They are connected to the respective inlet connectors on top of the reservoir: two 1/4"-connectors (one vertical, one horizontal), luer female connector. All inlet connectors drain the fluid into a filter via a filter holder. The ATR 40 contains a three-layer filter and the ATR 120 contains a two-layer filter that traps particulates greater than 40 and 120 microns, respectively. In both filters, the PUR foam is treated with a defoaming agent to dissolve bubbles generated in the blood collection process by mixing blood with air. Except for the filter ATR 40 and ATR 120 are identical. The filters are attached to the filter holder by a cable tie and hang like a pouch in the reservoir lumen. The vacuum is applied via a separate vacuum line attached to a 1/4" vacuum port. Positive and negative pressure level within the reservoir is limited by a pressure relief valve that opens in the range of approximately -300 mmHg and + 100 mmHg. Up to 3 liters of aspirated blood can pass through the filter and be stored in the reservoir lumen at one time. The volume of collected blood can be controlled by calibration marks on both sides of the reservoir; the calibration marks are in increments of 100 ml to 3000 ml. Collected blood can be transferred to an autotransfusion device via the outlet line attached to the reservoir. The flow of blood through the outlet line can be controlled with a pinch clamp. A universal adapter, compatible with 1/4" male adapters and 3/8" female connectors, it attached to the distal end of the outlet line for connection to autotransfusion tubing sets. The reservoir can be attached to an IV pole using a compatible reservoir holder or the hanger on top of the reservoir. The ATR 40 and ATR 120 Autotransfusion Devices are supplied as sterile (ETO) disposable devices with a non-pyrogenic fluid path.

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes substantial equivalence testing against predicate devices. The acceptance criteria are framed as "equal quality" or "substantially equivalent" to the predicate devices for specific performance aspects.

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

• Sample Size: The document does not explicitly state the sample sizes used for the comparative testing (e.g., number of devices tested, number of blood samples). It refers to "comparative testing" and states that "Data is provided to the Agency."
• Data Provenance: The document does not specify the country of origin or whether the data was retrospective or prospective. The testing was comparative against legally marketed predicate devices (Medtronic EL240 and Haemonetics Cell Saver®).

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

This type of information is not applicable to this submission. The device is a physical medical device (autotransfusion reservoir) undergoing performance and safety testing, not a diagnostic or AI-driven device requiring expert interpretation for ground truth. The "ground truth" here is the measured performance of the predicate devices.

4. Adjudication Method for the Test Set:

This information is not applicable. As it's a performance and safety test for a physical device, there's no "adjudication" in the sense of reconciling multiple expert opinions on a diagnostic outcome. The assessment is based on objective measurements against established standards and predicate device performance.

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 information is not applicable. This is a medical device (autotransfusion reservoir), not an AI or imaging diagnostic device. Therefore, MRMC studies or AI assistance for human readers are irrelevant to its evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable. This is a physical medical device. There is no "algorithm only" performance to evaluate. The device performs its function directly.

7. The Type of Ground Truth Used:

The ground truth used for comparison was the performance parameters of legally marketed predicate devices (Medtronic EL240 and Haemonetics Cell Saver®) and compliance with relevant industry standards (AAMI/ANSI for autotransfusion devices, FDA's modified ISO standards for biocompatibility).

8. The Sample Size for the Training Set:

This information is not applicable. This device is not an AI/machine learning model, so there is no "training set."

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

This information is not applicable. As there is no training set for an AI model, there is no ground truth to establish for it.

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The ATS Suction Line is a suction line to aspirate and anticoagulate blood from the surgical field into an autotransfusion reservoir with ¼" suction port connected to a vacuum source.

The ATY Y-Adapter is a Y-Adapter to connect two autotransfusion reservoirs with 1/4´´ female outlet connector to an autotransfusion device.

The ATO Oxygenator Line is a tubing system to connect an oxygenator with 1/4´´ male connector to an autotransfusion device: - via a Y-adapter connected to an autotransfusion reservoir; or

• directly to the autotransfusion device accepting a 1/4´´ female connector; or

• via an autotransfusion reservoir.

The ATS Suction Line consists of a double lumen tubing set for collection and anticoagulation of shed blood in surgery or trauma. The large tubing is used for aspiration of the shed blood. The small tubing welded to the large tubing provides anticoagulation. The large suction tube and small anticoagulation tube meet at the Yankauer adapter, to provide anticoagulation immediately after collection of blood. The suction line is connected to the appropriate collection reservoir by a ¼´´ female connector. The anticoagulant line is spiked to a anticoagulant container. Anticoagulant dosage is controlled by a roller clamp and regulates the drip rate of the anticoagulant into the drip chamber. The Yankauer adapter is designed to adapt to suction tips from 6.5 to 9.5 mm outer diameters.

The ATY Y-Adapter is a disposable tubing set used to connect two autotransfusion reservoirs to an autotransfusion disposable set prior to processing. Each branch of the Y-Adapter may be attached to the blood outlet port of two reservoirs by 2 stepped ¼´´ adapters. Each branch connecting to the reservoirs has a pinch clamp to control flow to the autotransfusion device. The Y-Adapter outlet line has a universal adapter fitting for ¼´ male connectors or 3/8´´ female connectors. Alternatively, the ATY Y-Adapter can be used to connect one autotransfusion reservoir and one oxygenator line to an autotransfusion device.

The ATO oxygenator line is a disposable tubing set for the collection or transfer of shed blood from the extracorporeal circulation (ECC) in cardiac surgery to an autotransfusion reservoir or to an autotransfusion device prior to processing. The is connected to the coronary perfusion port of an oxygenator prior to priming ECC. After conclusion of ECC, it may be connected to the free branch of a Y-adapter attached to an autotransfusion reservoir outlet, or directly to the blood inlet line of an autotransfusion device for direct processing. Alternatively it may be connected to a ¼" inlet connector of an autotransfusion reservoir to empty the oxygenator content into the reservoir prior to processing.

All three devices are for single patient use, sterilized using ethylene oxide gas, and the fluid paths are non-pyrogenic.

Acceptance Criteria and Device Performance Study for Fresenius C.A.T.S Autotransfusion Accessories

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not explicitly state the numerical sample sizes for each specific test (e.g., number of devices tested for structural integrity or biocompatibility). However, it implies testing was conducted on a sufficient number of devices to demonstrate compliance.

The data provenance is not explicitly stated in terms of country of origin. The studies appear to be retrospective in the sense that they were performed on manufactured devices to validate their properties and then submitted for regulatory approval.

3. Number of Experts and Qualifications for Ground Truth:

This document does not describe a study involving human experts to establish ground truth in the way one might for diagnostic imaging devices. The "ground truth" here is compliance with established engineering and biocompatibility standards. The experts involved would have been the internal Fresenius Hemotechnology, Inc. engineers, scientists, and regulatory affairs personnel responsible for designing, testing, and validating the devices against these predefined standards. Their qualifications would likely include expertise in biomaterials, medical device design, manufacturing, and regulatory compliance.

4. Adjudication Method:

Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or evaluations where human readers interpret data to establish ground truth (e.g., radiologists reading images). This type of adjudication is not applicable to the technical and performance testing described in this document for the autotransfusion accessories. The compliance was determined by direct measurement and analysis against predefined technical specifications and standards.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study assesses how human readers perform with and without AI assistance, which is irrelevant for these autotransfusion accessories as they are not AI-powered diagnostic or assistive devices requiring human interpretation.

6. Standalone Performance Study:

Yes, a standalone performance study was done in the sense that the devices themselves were tested against technical specifications and standards (e.g., biocompatibility testing, structural integrity testing, shelf-life studies). This testing focused solely on the inherent performance characteristics of the devices without human interaction other than setting up and operating the testing equipment. The goal was to prove the devices' ability to function as intended and safely under specified conditions.

7. Type of Ground Truth Used:

The ground truth used was based on established industry standards and regulatory requirements. Specifically:

• Biocompatibility: Applicable standards for cytotoxicity, sensitization, intracutaneous toxicity, systemic toxicity, hemocompatibility (hemolysis), genotoxicity, and pyrogenicity.
• Structural Integrity: Requirements to withstand twice the flow capacity and negative/positive pressures associated with autotransfusion device use.
• Packaging and Sterility: Requirements for protecting devices, maintaining sterility, and demonstrating a one-year shelf-life.
• Overall Suitability: Compliance with AAMI/ANSI standards for autotransfusion devices.

8. Sample Size for the Training Set:

This question is not applicable. These are medical devices (tubing sets, adapters) and not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The "training" in this context refers to the design and refinement process of the physical device, which typically involves iterations of prototypes and bench testing, but not a formally defined "training set" like in AI development.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no "training set" for these physical medical devices. The design and manufacturing process would be guided by engineering principles, material science, and regulatory requirements, with validation against the "ground truth" of established standards as described in point 7.

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