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Depending on the AMICUS Separator System disposable used in the therapeutic apheresis procedure, the AMICUS Separator System has been cleared for the following:

The AMICUS Separator System is an automated blood cell separator indicated to perform therapeutic plasma exchange (TPE). (K111702)

The AMICUS Exchange Kit is indicated for use in therapeutic plasma exchange (TPE). The kit is for use with the AMICUS separator. (K111702)

The AMICUS Separator System is an automated blood component separator indicated to perform red blood cell exchange (RBCX), including exchange and depletion/exchange procedures, for the transfusion management of sickle cell disease in adults and children. (K180615)

The AMICUS Exchange Kit – Therapeutics is indicated for use in therapeutic plasma exchange (TPE) and red blood cell exchange (RBCX). The kit is for use with the AMICUS separator. (K111702, K180615)

The waste transfer set is indicated for use in red blood cell exchange (RBCX). The set is for use with the AMICUS separator. (K180615)

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 (TPE) or red blood cell exchange (RBCX) therapeutic apheresis procedure. The set is for use with the AMICUS separator. (K111702, K180615)

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

Depending on the AMICUS Separator System apheresis kit used in the collection of products, the AMICUS Separator System has been cleared to collect:

• Platelets Pheresis, Leukocytes Reduced (single, double, or triple units)(BK960005, BK990009)
• Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (InterSol)(single, double or triple units) (BK090065)
• Red Blood Cells, Leukocytes Reduced (by apheresis) (BK000039)
• Mononuclear Cells (BK000047)
• Plasma (BK960005, BK120041)
• Fresh Frozen Plasma
• Must be prepared and placed in a freezer at -18° C or colder within eight hours after phlebotomy.
• Plasma Frozen Within 24 Hours After Phlebotomy (PF24)
• Must be stored at 1-6°C within eight hours after phlebotomy and placed in a freezer at -18° C or colder within 24 hours after phlebotomy.
• Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
• Plasma Frozen Within 24 Hours After Phlebotomy (PF24) Held at Room Temperature Up to 24 Hours After Phlebotomy (PF24RT24)
• Can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18° C or colder within 24 hours after phlebotomy.
• Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
• Source Plasma

The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5ml/kg and a donor post-platelet count greater than or equal to 100,000 platelets/microliter.

Platelet Pheresis (single, double, or triple units) may be manufactured from products that do not meet leukocyte reduction product standards. This does not apply to Platelet Additive Solution (InterSol) (single, double or triple units).

The AMICUS platelet storage container is cleared to store Platelets Pheresis, Leukocytes Reduced in 100% plasma for up to seven days. Additionally, for platelet units stored past five days and through seven days, every product must be tested with a bacterial device cleared by FDA and labeled as a "safety measure."

The AMICUS Separator System is comprised of the AMICUS separator instrument and a disposable apheresis kit specific to the procedure being performed. The instrument is a continuous-flow, centrifugal device that draws whole blood from a donor/patient, separates the blood into its components, collects one or more of the blood components, and returns the remainder of the blood components to the donor/patient. The instrument operates using pumps, clamps and valves that move donor/patient blood through a singleuse, sterile fluid path disposable kit. The cells are centrifugally separated within the kit by density differences.

The operator is responsible for connecting and monitoring the donor/patient and operating and monitoring the AMICUS separator during the procedure. The operator controls the separator through a touch screen. When necessary, the operator is warned of problems with messages on the screen and corresponding audible alerts.

Once the cell separation is complete, the operator disconnects the donor/patient, dismantles the kit, and disposes of the kit in a safe manner. The kit is packaged in a recyclable plastic tray.

The provided document is a 510(k) Premarket Notification from the FDA for the Fresenius Kabi AMICUS Separator System. This document is a regulatory approval letter and a summary of the device and its modifications, not a study report. As such, it does not contain the detailed performance study data, acceptance criteria, ground truth establishment methods, or sample sizes typically found in a clinical study report or a pre-market approval application for a novel device or a significant new indication.

The document states that the primary changes to the AMICUS device are:

• Replacement of obsolete controller circuit boards and associated redesign of other internal boards.
• Modification to the rear door design to accommodate new USB ports, Ethernet port, serial port, and Wi-Fi antenna.
• An update to the 6.0 software, including a change in the operating system from pSOS to QNX, to run on the proposed device with the new hardware.
• Qualification of a new off-the-shelf USB barcode scanner.

It explicitly states: "The software changes do not involve changes to the core blood component collection or therapeutic procedure functionality." and "The AMICUS disposable apheresis kits remain the same as the currently cleared kits, including design, materials and manufacturing methods."

The conclusion section states: "Software and systems verification testing of impacted requirements were performed with the replacement hardware components and updated 6.0 software. Regression testing was performed including paired testing with the predicate device on key product quality and performance characteristics. Results from the software and systems verification testing indicate that the subject device is as safe and performs as well as the predicate device."

Therefore, based on the provided text, I cannot extract the specific information requested in the prompt regarding acceptance criteria tables, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or detailed ground truth methodologies, because these types of studies were not conducted or reported in this 510(k) summary for a device modification, where the manufacturer is claiming substantial equivalence to a previously cleared predicate device due to hardware and software updates that do not alter core functionality. The "performance data" section primarily refers to verification testing (software and systems verification, regression testing compared to predicate, and electrical safety/EMC testing) rather than clinical performance studies with human subjects or expert readers that would typically involve the criteria you've listed.

In summary, the document describes a device modification rather than a new device or significant new indication. The approval relies on demonstrating substantial equivalence to existing, cleared devices, primarily through engineering verification and validation testing, and not necessarily new extensive human-based performance studies as would be the case for an AI/ML algorithm with diagnostic capabilities.

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Depending on the AMICUS Separator System disposable used in the therapeutic apheresis procedure, the AMICUS Separator System has been cleared for the following:

The AMICUS Separator System is an automated blood cell separator indicated to perform therapeutic plasma exchange (TPE). (K111702)

The AMICUS Exchange Kit is indicated for use in therapeutic plasma exchange (TPE). The kit is for use with the AMICUS separator. (K111702)

The AMICUS Separator System is an automated blood component separator indicated to perform red blood cell exchange (RBCX), including exchange and depletion/exchange procedures, for the transfusion management of sickle cell disease in adults and children. (K180615)

The AMICUS Exchange Kit – Therapeutics is indicated for use in therapeutic plasma exchange (TPE) and red blood cell exchange (RBCX). The kit is for use with the AMICUS separator. (K111702, K180615)

The waste transfer set is indicated for use in red blood cell exchange (RBCX). The set is for use with the AMICUS separator. (K180615)

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 (TPE) or red blood cell exchange (RBCX) therapeutic apheresis procedure. The set is for use with the AMICUS separator. (K111702, K180615)

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

Depending on the AMICUS Separator System apheresis kit used in the collection of products, the AMICUS Separator System has been cleared to collect:

• · Platelets Pheresis, Leukocytes Reduced (single, double, or triple units) (BK960005) (BK990009)
• · Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (InterSol) (single, double or triple units) (BK090065)
• · Red Blood Cells, Leukocytes Reduced (by apheresis) (BK000039)
• Mononuclear Cells (BK000047)
• · Plasma (BK960005, BK120041)
  • o Fresh Frozen Plasma

· Must be prepared and placed in a freezer at -18° C or colder within 8 hours after phlebotomy.

• o Plasma Frozen Within 24 Hours After Phlebotomy (PF24)
  • Must be stored at 1-6℃ within 8 hours after phlebotomy and placed in a freezer at -18° C or colder within 24 hours after phlebotomy.

· Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.

o Plasma Frozen Within 24 Hours After Phlebotomy (PF24) Held at Room Temperature Up to 24 Hours After Phlebotomy (PF24RT24)

• · Can be stored at room temperature for up to 24 hours after phlebotomy. Product must be placed in a freezer at -18° C or colder within 24 hours after phlebotomy.

• · Indicated for replacement of non-labile clotting factors. This product is not equivalent to Fresh Frozen Plasma.
  o Source Plasma

The device is designed to collect products while maintaining an extracorporeal volume at or below 10.5ml/kg and a donor post platelet count greater than or equal to 100,000 platelets/microliter. (BK080018)

Platelet Pheresis (single, double, or triple units) may be manufactured from products that do not meet leukocyte reduction product standards. This does not apply to Platelet Additive Solution (InterSol) (single, double, or triple units). (BK090065)

The AMICUS platelet storage container is cleared to store Platelets Pheresis, Leukocytes Reduced in 100% plasma for up to 7 days. Additionally, for platelet units stored past 5 days and through 7 days, every product must be tested with a bacterial device cleared by FDA and labeled as a "safety measure." (BK040059, BK150242)

The AMICUS Separator System is comprised of the AMICUS separator instrument and a disposable apheresis kit specific to the procedure being performed. The instrument is a continuous-flow, centrifugal device that draws whole blood from a donor/patient, separates the blood into its components, collects one or more of the blood components, and returns the remainder of the blood components to the donor/patient. The instrument operates using pumps, clamps and valves that move donor/patient blood through a single-use, sterile fluid path disposable kit. The cells are centrifugally separated within the kit by density differences.

The operator is responsible for connecting and monitoring the donor/patient and operating and monitoring the AMICUS separator during the procedure. The operator controls the separator through a touch screen. When necessary, the operator is warned of problems with messages on the screen and corresponding audible alarms.

Once the cell separation is complete, the operator disconnects the donor/patient, dismantles the kit, and disposes of the kit in a safe manner. The kit is packaged in a recyclable plastic tray.

The document provided describes a 510(k) premarket notification for the AMICUS Separator System, focusing on a software update (version 6.0). A 510(k) submission generally claims substantial equivalence to a predicate device, rather than providing extensive de novo clinical studies to establish new acceptance criteria and prove performance against those criteria in a traditional sense.

Therefore, the information requested, which typically relates to clinical studies establishing performance against defined acceptance criteria for a novel device, is not directly available in this type of FDA submission.

However, I can extract the information provided about the verification and validation activities for the software update and explain why some of the requested information is not applicable to a 510(k) for a software modification.

Here's a breakdown based on the provided text:

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

The document states that "Software and systems verifications were performed in support of this submission. The results of the testing were acceptable." However, it does not explicitly list specific acceptance criteria (e.g., in terms of sensitivity, specificity, accuracy for a diagnostic device, or specific performance metrics for a therapeutic device's outcome) and then report quantified performance against those criteria. This type of detailed breakdown is not typically required or provided in a 510(k) for a software enhancement to an already cleared device. The "acceptance criteria" here would be that the software performs its intended functions correctly and safely, as per the design specifications and referenced standards.

The performance is implicitly reported as "acceptable" based on the verification and validation, implying that the software modification did not negatively impact the previously established performance of the AMICUS Separator System, and likely improved the listed enhancements.

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

The document does not specify a "test set" in the context of clinical data for performance assessment. The "testing" mentioned refers to software and system verification, which would typically involve testing new functionalities, ensuring existing functionalities are preserved, and assessing system stability. The number of test cases run, or the number of simulated or actual apheresis procedures performed during verification, is not disclosed. Data provenance in this context would refer to the details of the testing environment rather than patient data.

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

This information is not applicable. For a software update to an existing apheresis system, "ground truth" as established by medical experts (e.g., radiologists, pathologists) is not relevant in the same way it would be for a diagnostic AI device. Software verification focuses on functional correctness, safety, and adherence to design specifications.

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

Not applicable for software verification. Adjudication methods are typically used in clinical studies where multiple experts assess cases and their opinions need to be reconciled to establish a ground truth.

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:

Not applicable. This device is an automated blood cell separator, not a diagnostic AI device that assists human readers. No MRMC study would be performed for this type of device.

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

The device (AMICUS Separator System) is inherently a "human-in-the-loop" system, as an operator connects and monitors the donor/patient and operates the separator. The software is part of this system. Therefore, the concept of "standalone" algorithm performance as typically applied to AI for diagnosis is not directly relevant here. The software verification assesses the behavior and functionality of the software within the context of the overall system and its intended use.

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

Not applicable. The "ground truth" for software verification typically involves the design specifications and expected behavior of the software functions. For example, if a new feature is added to calculate a specific parameter, the "ground truth" is that the calculation is correct according to the mathematical formula and clinical parameters.

8. The sample size for the training set:

Not applicable. This is a software update for a control system, not a machine learning model that requires a training set of data.

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

Not applicable. See point 8.

Summary of what is known from the document regarding meeting acceptance criteria:

The document emphasizes that "Software and systems verifications were performed in support of this submission. The results of the testing were acceptable."

The study (or rather, the verification and validation activities) that proves the device meets (implicitly defined) acceptance criteria is described as compliant with recognized standards and guidance documents:

• IEC 62304 Ed. 1.0, "Medical device software Software life cycle processes": This standard outlines requirements for the software development life cycle of medical device software, ensuring safety and quality.
• ISO 14971:2012 Medical Devices – Applications of Risk Management to Medical Devices: This standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
• FDA/CDRH "General Principles of Software Validation; Final Guidance for Industry and FDA Staff." Issued January 11, 2002: This guidance outlines the FDA's current thinking on general principles of software validation for medical devices.
• ES 60601-1:2005/(R)2012 and A1:2012, C1: 2009/(R)2012 and A2:2010/(R)2012. Medical electrical equipment - Part 1: General requirements for basic safety and essential performance: This standard addresses the basic safety and essential performance requirements for medical electrical equipment.

The conclusion states: "Based on the verification activities performed, the AMICUS Separator System modified with software 6.0 provides a device system that is substantially equivalent to the currently marketed AMICUS Separator System." This indicates that the software enhancements were verified to perform as intended and not introduce new safety or performance concerns, thus maintaining substantial equivalence to the predicate device.

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