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The AMICUS Separator System is an automated blood cell separator indicated for the collection of blood components and mononuclear cells.

The AMICUS Separator System is an automated blood cell separator indicated to perform Therapeutic Plasma Exchange (TPE).

The Blood Component Filter Set with Vented Spike and Luer Adapter is indicated for the administration of blood and blood components during a therapeutic plasma exchange procedure. For use with the AMICUS Separator System.

The AMICUS separator is a continuous-flow, centrifugal device that separates whole blood into its components. Blood components are collected using sterile fluid path, single-use, apheresis kits. The cells are centrifugally separated within the kit by density differences.

The Therapeutic Plasma Exchange (TPE) procedure is an apheresis collection procedure coupled with an infusion procedure. The collected plasma, which contains most of the anticoagulant, is pumped to a waste container(s). The patient's WBCs, the majority of platelets and a small amount of plasma and anticoagulant are mixed with a physician-prescribed replacement fluid, such as FFP, human albumin and/or crystalloid solutions, and returned to the patient. This process continues until the target plasma volume has been removed and replaced per physician order.

The operator is responsible for preparing and monitoring the patient as well as operating and monitoring the AMICUS separator during the TPE procedure. The operator controls the separator through a touch screen. When necessary, the operator is alerted to problems, or given notes via messages displayed on the screen with corresponding audible alarms. Once complete, the operator disconnects the donor/patient, removes the kit, and disposes of the kit per institutional SOPs. The kit is packaged in a recyclable plastic tray.

The Blood Component Filter Set with Vented Spike and Luer Adapter is an optional accessory intended to be used in conjunction with the AMICUS Separator System in Therapeutic Plasma Exchange (TPE) procedures to administer physician prescribed replacement fluids during the TPE procedure, when blood component filtration is needed (e.g. when using fresh frozen plasma). The filter set has a common blood transfusion set design and is comprised of a blood component filter, tubing, vented spike and a luer lock/cap. The filter set is a single use, sterile fluid path intravascular administration set. The filter set is connected to the TPE kit via the male luer connector and the vented spike is used to access the prescribed replacement fluid container. The flow rate through the filter set is controlled by the AMCUS Separator System.

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

AMICUS® Separator System - Use in Therapeutic Plasma Exchange

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated as a number of patients or procedures. The text refers to "test procedures" and "control procedures" as groups within a clinical evaluation. It doesn't break down the exact number of participants in each.
• Data Provenance: The study was a "clinical evaluation," suggesting a prospective study. The country of origin of the data is not specified in the provided text.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the text. The study evaluates the device's technical performance (plasma removal efficiency, fluid balance, etc.) rather than diagnostic accuracy requiring expert consensus on images or interpretations.

4. Adjudication Method for the Test Set

This information is not applicable as the study focused on objective performance metrics of a medical device, not on diagnostic interpretations requiring adjudication.

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

A MRMC comparative effectiveness study was not conducted. This study evaluates the performance of a medical device (AMICUS Separator System) in performing a therapeutic procedure (Therapeutic Plasma Exchange), not the interpretive skills of human readers.

6. Standalone Performance

Yes, a standalone performance study (clinical evaluation) was done. The study specifically compared the AMICUS Separator System's performance (Test group) against a "Control group" (which, based on context, appears to be the predicate device, COBE Spectra). The reported metrics (plasma removal efficiency, fluid balance, platelet loss, plasma hemoglobin) directly reflect the algorithm's (device's) performance.

7. Type of Ground Truth Used

The "ground truth" for this study was objective clinical performance metrics measured during the Therapeutic Plasma Exchange procedures. These include:

• Efficiency of plasma removal (quantified percentage).
• Fluid balance (accuracy of maintenance).
• Levels of platelet loss in waste plasma.
• Levels of plasma hemoglobin in waste plasma.

8. Sample Size for the Training Set

This information is not applicable/not provided. The AMICUS Separator System is a medical device, not an AI/ML algorithm that is "trained" on a dataset in the typical sense. Its operational parameters and software are developed through engineering and verification/validation processes, not machine learning training.

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

This information is not applicable/not provided for the same reason as point 8. The device's operation is based on established engineering principles and extensive system validation and verification activities, rather than a machine learning training paradigm.

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