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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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