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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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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 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 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.

Acceptance Criteria and Device Performance for AMICUS Separator System (K180615)

The AMICUS Separator System, specifically for Red Blood Cell Exchange (RBCX) procedures, underwent clinical studies to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

• AMIC-003-CMD:
  • Sample Size: 59 evaluable procedures.
  • Data Provenance: Prospective, multi-site investigational study. The country of origin is not explicitly stated, but it is implied to be within the scope of where FDA clinical trials are conducted (e.g., USA).
• AMIC-004-CMD:
  • Sample Size: 36 evaluable procedures.
  • Data Provenance: Prospective, single-site investigational study. The country of origin is not explicitly stated, but it is implied to be within the scope of where FDA clinical trials are conducted (e.g., USA).

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

The provided document describes clinical studies that directly measured device performance (e.g., FCR, End Hct) using laboratory analyses of patient blood samples. It does not mention the use of "experts" to establish a separate "ground truth" or reference standard for the device's analytical performance, as would be common in diagnostic imaging or clinical decision support AI. The ground truth for this device's performance metrics (FCR, hematocrit) would have been established through standard clinical laboratory procedures performed on patient samples, likely adhering to existing clinical guidelines.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the context of expert review for establishing ground truth, as the studies are focused on direct clinical performance measurements (e.g., FCR, hematocrit) from patient data. Clinical events (adverse events) would typically be reviewed by an independent safety committee or investigators.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The AMICUS Separator System is an automated blood processing device, and its performance is evaluated based on its technical output (e.g., FCR, hematocrit) in patients, not on human interpretation of data. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this device.

6. Standalone Performance Study

Yes, standalone performance studies were done. The clinical studies (AMIC-003-CMD and AMIC-004-CMD) evaluated the performance of the AMICUS Separator System as a standalone device in performing RBCX procedures. The results reported (e.g., A:T FCR ratio, A:T End Hct ratio) are direct measures of the algorithm's and system's performance.

7. Type of Ground Truth Used

The ground truth used was outcomes data and patient laboratory measurements.

• For AMIC-003-CMD, the primary endpoint focused on the Actual FCR (Fraction of Cells Remaining) as measured by the subject's post-procedure Hb S, compared to the Target FCR. This is a direct laboratory measurement of the effectiveness of the exchange.
• For AMIC-004-CMD, the primary objective was the Actual End Hct (hematocrit) post-procedure compared to the Target End Hct. This is also a direct laboratory measurement indicating the effectiveness of the depletion.
• Additionally, safety was assessed by observing adverse events and changes in subject cellular losses (WBC and platelet counts), which also constitute clinical outcomes data.

8. Sample Size for the Training Set

The document does not explicitly mention a separate "training set" with a specified sample size for algorithm development. It refers to "internal in vitro studies using bagged blood" conducted during product development to assess performance and safety. These in vitro studies, along with system verification and validation activities, would have implicitly served some function akin to algorithm training and refinement, but a distinct "training set" with specific sample sizes from patients is not detailed as per AI/ML terminology. The clinical studies (AMIC-003-CMD and AMIC-004-CMD) are evaluation studies, acting as the test sets for the finalized device software.

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

As noted above, a distinct "training set" in the AI/ML sense is not explicitly described. However, the ground truth for the in vitro studies during development would have been established through:

• Direct laboratory measurements: For parameters like FCR and hematocrit using established analytical methods from the bagged blood samples.
• Comparison to predicate devices: The document states that these in vitro studies "concurrently collected data on the COBE Spectra Apheresis System for comparison. Overall study results showed that both devices are capable of meeting performance targets." This indicates that the performance of the predicate device served as a benchmark for establishing expected performance characteristics during the development phase.

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

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

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

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)
• · Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (InterSol) (single, double or triple units)
• · Red Blood Cells, Leukocytes Reduced (by apheresis)
• Mononuclear Cells
• Plasma
• 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°C 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

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 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."

NOTE - No changes to the AMICUS Separator System indications for use are requested in this 510(k) filing.

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 preparing and monitoring the donor/patient and operating and monitoring the AMICUS separator during the automatic blood collection cycle. 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 removes the needle(s) from 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 Fresenius Kabi AMICUS Separator System, with software version 5.1, underwent performance testing to support its substantial equivalence claim. While the provided document states that "Software and systems verification were performed in support of this submission. The results of the testing were acceptable," it does not include a detailed table of acceptance criteria nor the reported device performance metrics from a formal study. It references that the changes were "procedure enhancements and correction of anomalies" and does not present data in the format of a clinical study with specific acceptance criteria and results.

Therefore, the following information is extracted and synthesized based on the available text, with caveats for missing details.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific acceptance criteria or quantitative performance results from a study. It generally states that the "results of the testing were acceptable." The device's performance claims are tied to its indications for use, such as maintaining an extracorporeal volume at or below 10.5 mL/kg and a donor post platelet count greater than or equal to 100,000 platelets/microliter. However, no specific study data is presented to demonstrate meeting these criteria with software 5.1.

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

The document does not specify the sample size for any test sets or the provenance of data (e.g., country of origin, retrospective or prospective) for the software and systems verification.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the use of experts to establish ground truth or their qualifications for the testing of software version 5.1. The "software and systems verification" typically involves engineering and quality assurance personnel, not necessarily medical experts establishing ground truth in a clinical context.

4. Adjudication Method for the Test Set

No information is provided regarding any adjudication method, as the testing described appears to be software and system verification, not a clinical study requiring expert consensus or adjudication.

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

An MRMC study was not done or at least not reported in this document. The device is an automated blood cell separator, not an imaging or diagnostic AI requiring human-in-the-loop performance evaluation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The "Software and systems verification" serves as a standalone performance evaluation of the modified software. While the document does not label it as such, the nature of the device (automated blood cell separator) means its primary function is standalone operation without continuous human interpretation similar to an AI diagnostic tool. No specific performance metrics for this standalone evaluation are provided beyond "acceptable."

7. Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, outcomes data, expert consensus) is not directly applicable here. For software and systems verification, the "ground truth" would be the pre-defined functional specifications and performance requirements for the software and the overall system. These would be established through engineering design, regulatory standards, and previous device clearances.

8. Sample Size for the Training Set

The document does not mention a training set. This is a software and system update for an existing medical device, not a machine learning model developed with training data.

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

Not applicable, as there is no mention of a training set.

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The AMICUS Separator System is an automated blood cell separator intended for use in therapeutic apheresis applications and may be used to perform Therapeutic Plasma Exchange (TPE).

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

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

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) .
• Platelets Pheresis, Leukocytes Reduced, Platelet Additive Solution (InterSol) (single, double . or triple units)
• Red Blood Cells, Leukocytes Reduced (by apheresis) .
• . Mononuclear Cells
• Plasma .
  • 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°C 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

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 Pheresis, Platelet Additive Solution (InterSol) (single, double, or triple units).

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 preparing and monitoring the donor/patient and operating and monitoring the AMICUS separator during the automatic blood collection cycle. 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 removes the needle(s) from the donor/patient, dismantles the kit, and disposes of the kit in a safe manner. The kit is packaged in a recyclable plastic tray.

This document describes a 510(k) premarket notification for a software update (version 4.5) to the AMICUS Separator System, an automated blood cell separator. The purpose of this submission is to demonstrate substantial equivalence to the currently marketed AMICUS Separator System.

Here's an analysis of the provided information, focusing on acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state numerical acceptance criteria in a dedicated table format with corresponding performance results. Instead, it broadly mentions that "Software verification, systems verification and systems validation were performed in support of this submission. The results of the testing were acceptable."

The core acceptance criterion implicitly stated and tested is substantial equivalence to the predicate device, especially regarding the described enhancements in software version 4.5. These enhancements primarily focus on:

• Automated custom prime in Mononuclear (MNC) and Therapeutic Plasma Exchange (TPE) procedures to maintain isovolemia.
• Functionality to pump saline during TPE procedures.
• Additional input parameters and output values (e.g., Product Volume and ACD in Product for MNC, in line with FACT requirements).
• Additional instruction screens and other minor enhancements.

The "reported device performance" is summarized as:

The conclusion explicitly states: "Based on the validation and verification activities performed, the AMICUS Separator System modified with software 4.5 provides a device system that is substantially equivalent to the currently marketed AMICUS Separator System." This implies all these implicit criteria were met.

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 provides very limited detail on the specifics of the test set, sample size, or data provenance. It only states: "Software verification, systems verification and systems validation were performed in support of this submission."

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). Given this is a software update for an existing device, it's likely that internal testing, possibly using simulated data or real-world operational data from in-house labs or clinical sites, was conducted.

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)

This is not applicable in the context of this submission. The device is an automated blood cell separator, and the submission concerns a software update. "Ground truth" in this context would typically refer to the correct functioning of the software according to specifications, and the accuracy of its calculations and controls. This would be established through engineering and software testing protocols, not by expert consensus on clinical findings.

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

Not applicable. This type of adjudication method is used in studies where human interpretation (e.g., image reading) requires consensus, which is not the nature of the validation described. Software and system validation typically involve comparing system outputs against predefined specifications and expected results, not human adjudication of subjective interpretations.

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. The AMICUS Separator System is an automated blood processing device, not an AI-assisted diagnostic or interpretive tool for human readers. Therefore, an MRMC study related to human reading performance with or without AI assistance is not relevant to this submission.

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

Yes, implicitly. The "Software verification, systems verification and systems validation" would involve extensive testing of the algorithm (software) in various scenarios, both in isolation ("standalone") and within the full system, to ensure it performs according to its design specifications. While a specific "standalone" study isn't detailed, the nature of software and system validation inherently includes rigorous testing of the automated functions without direct human intervention impacting the internal logic or calculations. The human "operator" monitors the system, but the core function of separation and collection is automated by the device's algorithms.

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

For the software verification and validation, the "ground truth" would be the pre-defined design specifications and expected outputs of the software and system. For example:

• For the custom prime function: The ground truth would be that the system accurately calculates and delivers the prescribed priming fluid volume while maintaining isovolemia as specified in the design requirements.
• For saline pumping: The ground truth would be precise delivery of saline according to operator input and system control.
• For new output parameters (e.g., MNC Product Volume, ACD in Product): The ground truth would be the accurate calculation and display of these values based on the internal measurements and algorithms, consistent with FACT requirements where applicable.

This "ground truth" is established by the engineering and scientific principles governing the device's operation and the regulatory/clinical standards it must meet (e.g., FACT requirements mentioned for MNC output values).

8. The sample size for the training set

Not applicable. This submission is for a software update to an automated device, not a machine learning or AI-driven system that would typically require a "training set" in the context of learning algorithms. The software's logic is explicitly programmed based on engineering principles and clinical requirements, not "trained" on a dataset.

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

Not applicable, as there is no "training set" in the machine learning sense. The "ground truth" (i.e., correct behavior and outputs) for the software was established through engineering design, scientific principles, and adherence to specific performance requirements and regulatory standards for blood processing devices.

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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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