Search Results

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.

Ask a specific question about this device

The Spectra Optia® Apheresis System, a blood component separator, may be used to perform therapeutic plasma exchange.

The Spectra Optia® Apheresis System, a blood component separator. may be used to perform Red Blood Cell Exchange (RBCX) procedures for the transfusion management of Sickle Cell Disease in adults and children.

The Spectra Optia® Apheresis System, a blood component separator, may be used to reduce White Blood Cells for patients with leukocytosis at risk for leukostasis.

The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The cleared system is comprised of three major subsystems:

1. the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.)
2. a sterile, single-use, disposable blood tubing set
3. embedded software

The modification described in this submission introduces a new software version to the Spectra Optia Apheresis System. The current release is Version 11.3 which was cleared in K153601. The new software version is Version 12 and introduces the following new features:

• Data Management Support,
• Network Support,
• Enhancements to existing protocols including the ability to run the Red Blood Cell Exchange procedure in single-needle mode,
• General Software Maintenance Updates

The provided text describes a 510(k) premarket notification for the "Spectra Optia® Apheresis System" with an updated software version (Version 12). The submission aims to establish substantial equivalence to a predicate device (Spectra Optia® Apheresis System with Version 11.3 software).

The information provided is not sufficient to fully answer all aspects of your request, especially regarding specific acceptance criteria values and a detailed study report that would typically accompany a clinical trial or performance study. The document primarily focuses on demonstrating substantial equivalence through software and specification testing, rather than a detailed device performance study against specific, quantified acceptance criteria for clinical outcomes.

However, I can extract the available information as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific, quantifiable acceptance criteria established prior to testing, nor does it present detailed numerical performance results for the device. Instead, it states high-level outcomes indicating that the device met its functional requirements and specifications.

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

• Software Testing: No specific sample size (e.g., number of test cases run) is provided, but it states "All software testing was complete."
• Specification Testing: No specific sample size (e.g., number of tests or subjects) is provided.
• Single-Needle Functionality (Simulated Patient Study): The clinical overview report mentions a "simulated-patient laboratory study evaluating varying performance measures across the multiple RBCX Procedure Types." No specific sample size (number of simulated patients or runs) is given.
• Data Provenance: Not specified. The document does not indicate country of origin or if the "simulated-patient laboratory study" was retrospective or prospective. The "clinical overview report" likely summarizes existing clinical evidence, which would be retrospective if it refers to previously published data.

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

This information is not provided in the document. The studies mentioned (software testing, specification testing, simulated-patient study) do not explicitly refer to "ground truth" established by external experts in the way that, for example, an AI diagnostic device would. For the simulated-patient study, the "ground truth" would likely be the known parameters of the simulated blood and the expected output of the device.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the testing described (software, specification, simulated patient), an external adjudication method (like 2+1 or 3+1 for expert review) is not typically applicable or detailed in this type of submission.

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

There is no indication of an MRMC study being performed. The device is an apheresis system, not an AI diagnostic imaging system that would typically involve human readers.

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

The provided text describes software testing, which inherently assesses the algorithm's functionality. The "simulated-patient laboratory study" for single-needle functionality assesses the device's performance in a controlled environment, which could be considered a standalone performance assessment of the system for that specific function. However, the term "standalone" in the context of AI is usually understood as the algorithm making a decision without human intervention in a diagnostic setting. This is not the context of this device.

7. The Type of Ground Truth Used

• Software and Specification Testing: The ground truth for this testing would be the predefined system requirements and software specifications. The software is expected to operate according to its design and functional specifications.
• Simulated-patient laboratory study: The ground truth would be the known properties of the simulated blood and the expected physiological outcomes or separation efficiencies established as part of the study design.

8. The Sample Size for the Training Set

This information is not applicable / not provided. The Spectra Optia® Apheresis System is a medical device with an updated software version; it is not described as an AI/ML system that utilizes a "training set" in the conventional sense for developing a predictive model. The software is developed through traditional software engineering processes.

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

This information is not applicable / not provided, as there is no mention of a "training set" for an AI/ML model.

Ask a specific question about this device

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.

Ask a specific question about this device

The Spectra Optia® Apheresis System, a blood component separator, may be used to perform therapeutic plasma exchange.

The Spectra Optia® Apheresis System, a blood component separator, may be used to perform Red Blood Cell Exchange (RBCX) procedures for the transfusion management of Sickle Cell Disease in adults and children.

The Spectra Optia® Apheresis System, a blood component separator, may be used to reduce White Blood Cells for patients with leukocytosis at risk for leukostasis.

The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The cleared system is comprised of three major subsystems:

1. the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.)
2. a sterile, single-use, disposable blood tubing set
3. embedded software

The modifications described in this submission are those required to resolve current obsolescence issues for various electronic components found within the Spectra Optia equipment.

The provided text describes a 510(k) premarket notification for the Terumo BCT, Inc. Spectra Optia® Apheresis System. It focuses on demonstrating substantial equivalence to a predicate device, particularly regarding hardware modifications due to obsolescence. Crucially, the document does not contain information about the device's performance through a clinical study with acceptance criteria in the way one might expect for an AI/ML medical device.

Instead, the "performance data" section states: "A summary of the verification testing and a summary of the validation testing was presented to show that the modified device met all the performance requirements and that the subject device is as safe and performs as well as the predicate device." This refers to engineering verification and validation (V&V) activities for hardware changes, not a clinical study involving human subjects or AI performance metrics.

Therefore, many of the requested details, such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance with ground truth, and training set information for AI, are not applicable or available in this document.

However, I can extract the acceptance criteria (in terms of performance requirements) as implied by the statement regarding meeting "all the performance requirements" and being "as safe and performs as well as the predicate device." The study proving this is the "verification and validation tests" mentioned.

Here's the breakdown of the available and applicable information:

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

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

• Not applicable/Not provided. The document describes engineering verification and validation for hardware component changes, not a clinical study with a test set of patient data.

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)

• Not applicable/Not provided. No "ground truth" in the context of clinical expert review is mentioned, as this is not a clinical study using patient data for diagnostic classification.

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

• Not applicable/Not provided. No adjudication method for a test set is relevant to the type of V&V described.

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/Not provided. This document does not describe an AI/ML device or an MRMC study.

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

• Not applicable/Not provided. This device is a hardware system, not an algorithm.

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

• Not applicable/Not provided. The "ground truth" for the engineering verification and validation would be the design specifications and performance characteristics of the original (predicate) device, against which the modified device was tested to ensure it met those pre-defined engineering and functional requirements.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI/ML device, so there is no training set.

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

• Not applicable/Not provided. As there is no training set for an AI/ML device, this question is not relevant.

In summary: The provided document is a 510(k) submission for a hardware modification to an existing apheresis system. The "study" proving acceptance criteria is the verification and validation (V&V) tests conducted on the modified system to ensure it performs equivalently to the predicate device, specifically addressing functional and safety requirements rather than clinical performance metrics in a patient population or AI/ML diagnostic accuracy.

Ask a specific question about this device

The Spectra Optia® Apheresis System, a blood component separator, may be used to perform therapeutic plasma exchange.

The Spectra Optia® Apheresis System, a blood component separator. may be used to perform Red Blood Cell Exchange (RBCX) procedures for the transfusion management of Sickle Cell Disease in adults and children.

The Spectra Optia® Apheresis System, a blood component separator, may be used to reduce White Blood Cells for patients with leukocytosis at risk for leukostasis.

The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The cleared system is comprised of three major subsystems:

• 1. the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.)
• 2. a sterile, single-use, disposable blood tubing set
• 3. embedded software

This 510(k) involves no change in the components (design or material) of the Spectra Optia® Apheresis System. Instead, the purpose of this 510(k) is to expand the indications for use to include reduction of White Blood Cells (WBCs) for patients with leukocytosis at risk of leukostasis.

The provided text describes the performance study for the Spectra Optia® Apheresis System, specifically for its expanded indication of reducing White Blood Cells for patients with leukocytosis at risk of leukostasis.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria values in a table format for the effectiveness endpoints. Instead, it compares the observed performance to existing guidelines and predicate device performance.

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

• Sample Size (Clinical Data/Test Set): 43 subjects who underwent a total of 58 WBC Depletion procedures.
• Data Provenance:
  • Country of Origin: Europe (UZ Leuven, Belgium; Institute for Transfusion Medicine and Immunohematology, Frankfurt, Germany; Saint Istvan and Saint Laszlo Hospital, Budapest, Hungary).
  • Nature: Retrospective data collection study.

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

The document does not describe the use of experts to establish ground truth for this specific study. The "ground truth" for effectiveness (WBC reduction, CE) was based on measured physiological parameters directly obtained from the device and patient samples. For safety, it was based on reported adverse events. This is a clinical performance study of a therapeutic apheresis system, not an AI/imaging diagnostic study that typically involves expert panel review.

4. Adjudication Method for the Test Set

Not applicable, as this was a clinical performance study involving direct measurements and adverse event reporting, not a study requiring expert adjudication of interpretations (like in imaging studies).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This study focuses on the direct physiological performance and safety of the device itself, not on human reader performance with or without AI assistance.

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

Yes, in a sense, the primary clinical effectiveness and safety endpoints evaluate the "standalone" performance of the Spectra Optia® Apheresis System in affecting WBC counts in patients. The system itself is an automated device, and its performance metrics (WBC reduction, CE) reflect its direct action on blood.

7. The Type of Ground Truth Used

The ground truth for this device's performance was established via:

• Direct Physiological Measurements: Percent decrease in WBC count in subject blood post-procedure, and percent of processed WBCs collection efficiency (CE). These are objective, quantitative measurements from the patient samples.
• Clinical Outcomes/Adverse Events: Evaluation of clinical safety through the reporting and assessment of adverse events.
• Comparison to Established Guidelines/Literature: The observed WBC reduction was compared against ASFA (American Society for Apheresis) guidelines.

8. The Sample Size for the Training Set

This document describes a clinical performance study for an established medical device (with an expanded indication), not a study involving the training of a new AI algorithm. Therefore, there is no mention of a "training set" in the context of machine learning. The device's operation is based on established engineering principles of blood separation, not on a data-trained AI model.

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

As there is no mention of a training set for an AI algorithm, this question is not applicable to the provided information. The device's operational parameters and algorithms are determined through engineering design and historical data from previous clearances (e.g., K071079, K153601, K132429, BK120012, BK150251, BK130065, BK140191).

Ask a specific question about this device

The Spectra Optia Apheresis System, a blood component separator, may be used to perform therapeutic plasma exchange.

The Spectra Optia Apheresis System, a blood component separator, may be used to perform Red Blood Cell Exchange (RBCX) procedures for the transfusion management of Sickle Cell Disease in adults and children.

The Spectra Optia Apheresis System is comprised of three subsystems: the apheresis machine (or equipment), embedded software, and a single-use disposable blood tubing set. The modifications described in this submission impact the embedded software.

Spectra Optia Machine and Embedded Software: As described previously (K071079, BK140191, K151368), the Spectra Optia Apheresis System is an automated, centrifugal, blood component separation device that uses pumps, valves and sensors to control and monitor a disposable, plastic extracorporeal circuit, during therapeutic apheresis procedures. The system's embedded software controls pump flow rates and centrifuge speed to establish and maintain the required plasma/cellular interface, and ensure patient safety.

The provided text describes a 510(k) premarket notification for the Spectra Optia Apheresis System, specifically a minor software update (Version 11.3). The document focuses on demonstrating that this software update does not impact the device's fundamental scientific technology or principle of operation and that it has been adequately verified and validated.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly linked to the successful completion of various verification and validation tests, ensuring the software update addresses its intended purpose (mitigating use-errors related to patient height and weight entry) without introducing new safety concerns or altering the device's fundamental function. The reported device performance is that all tests passed.

1. Sample Size for Test Set and Data Provenance

• Software Verification Type testing: The "Number of Verifications" column in Table 6-1 indicates the sample size for these tests (e.g., 110 for "New / Updated Requirements"). Data provenance is not specified but appears to be internal testing by Terumo BCT.
• Human Factors Summative Study:
  • Sample size: 23 active Spectra Optia users.
  • Data Provenance: Not explicitly stated, but the users are described as "active Spectra Optia users," suggesting they are likely from real-world clinical or laboratory settings, implying prospective data collection during the study. The study was conducted on a "software simulator," not directly on patients.

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

• Software Verification Type testing: The document does not specify the number or qualifications of experts for establishing ground truth for the software verification tests. These likely involved internal engineering and quality assurance personnel.
• Human Factors Summative Study: The "ground truth" for this study was the successful completion of tasks related to patient height, weight, and TBV entry with correct units and no performance failures. This "ground truth" was established based on the intended correct usage of the software. The study observed user performance to confirm this. No external experts beyond the study design team are explicitly mentioned for establishing this truth.

3. Adjudication Method for the Test Set

• Software Verification Type testing: The document does not describe an adjudication method beyond the pass/fail results for each test. This suggests that the test outcomes were directly assessed against pre-defined criteria without further expert adjudication post-test.
• Human Factors Summative Study: The study observed subjects' ability to use correct units and verify entered data, with "no performance failures observed." This implies direct observation against predefined success criteria, rather than a multi-expert adjudication of ambiguous cases.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance?

• No, an MRMC comparative effectiveness study was not done. This document describes a software update for an apheresis system, which is a medical device for blood component separation, not an AI-assisted diagnostic or image interpretation tool. The device facilitates a physical procedure rather than providing diagnostic interpretations involving human "readers" or "AI assistance." Therefore, this type of study and effect size is not applicable.

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

• Partially, yes. The "Software Verification Type testing" (Table 6-1) represents standalone algorithm testing to a significant extent, particularly for "New / Updated Requirements," "Safety Regression Tests," "Compatibility (upgrade)," and "Reliability." These tests assess the software's inherent function without necessarily a human actively operating it in a simulated or real patient scenario for every single verification. For instance, safety regression tests would likely involve automated checks against known hazardous conditions.
• However, "Internal Usability" and the "Human Factors (Summative) Study" did involve humans in the loop to assess the human-device interface and mitigate use-errors by operators.

6. The Type of Ground Truth Used

• Pre-defined Engineering/Software Requirements and Safety Criteria: For the "Software Verification Type testing," the ground truth was derived from the established design specifications, functional requirements, safety criteria, and compatibility requirements for the software. A "pass" indicates the software met these predefined criteria.
• Intended Correct User Performance: For the "Human Factors (Summative) Study," the ground truth was the correct execution of critical tasks (entering patient height, weight, and TBV with correct units and verification). The study assessed whether users could achieve this intended correct performance.

7. The Sample Size for the Training Set

• The document does not mention a training set. This is because the device described is an apheresis system with embedded software, not a machine learning or AI-driven system that typically requires a distinct training dataset. The software update is a traditional, rule-based or algorithmic software modification.

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

• As a training set is not mentioned, the method for establishing its ground truth is not applicable/not provided.

Ask a specific question about this device

The Spectra Optia Apheresis System, a blood component separator, may be used to perform therapeutic plasma exchange.

The Spectra Optia Apheresis System, a blood component separator, may be used to perform Red Blood Cell Exchange (RBCX) procedures for the transfusion management of Sickle Cell Disease in adults and children.

The Spectra Optia Apheresis System is comprised of three subsystems: the apheresis machine (or equipment), embedded software, and a single-use disposable blood tubing set. The modifications described in this submission enhance the disposable set's safety during therapeutic plasma (TPE) and red blood cell exchange (RBCX) procedures and usability with the optional Wireless Solution.

The Spectra Optia Apheresis System is an automated, centrifugal, blood component separation device that uses pumps, valves and sensors to control and monitor a disposable, plastic, extracorporeal circuit, during therapeutic apheresis procedures. The system's embedded software controls pump flow rates and centrifuge speed to establish and maintain the required plasma/cellular interface, and ensure patient safety.

The disposable Spectra Optia Exchange Set (Catalog No. 12220) is provided sterile and is intended for single-use only. The set is invasive, in that patients are connected to the disposable using a needle or other blood access device (catheter, port, etc.) during the procedure. The patient's blood comes into direct contact with the biocompatible materials that comprise the set. Key components of the set include the [1] centrifuge channel (inside which the patient's blood is separated into its components), [2] the plastic cassette that integrates the tubing/defines the fluid path for ease of installation and use and, [3] the pre-attached waste bag into which the unwanted blood component is collected. Terumo BCT is replacing the standard spike located on the anticoagulant line with a unique luer that is not compatible with any other connection on the set to decrease operators from connecting the wrong solutions bag.

The Spectra Optia Wireless Solution includes both a mounting system and a wireless appliance. No modifications were made to the Spectra Optia device in support of the wireless solution. Neither the intended use of the device nor the intended use environment of the Spectra Optia has been modified in support of the wireless solution option.

The Exchange tubing set, catalog number 12220, is identical to the previously cleared Exchange set, catalog number 10220 (K141938), except the AC spike port is replaced with the new unique AC luer connector. The AC line is used to carry anticoagulant from the AC container to the inlet line manifold.

The Anticoagulant (AC) Connection Adapter, catalog number 11221, is used to connect an apheresis tubing set that has a luer connector to an anticoagulant solution container that has a spike receptor. The anticoagulant solution container can be collapsible, such as a bag, or hardsided, such as a bottle. The Anticoagulant Connection Adapter is sterilized by Ethylene Oxide, for single use only, and includes the following components:

• 1. AC (anticoagulant) connector with end cap: used to connect to the luer connector on the AC line of a tubing set
• 2. Vent: used when connecting to a hard-sided AC container
• 3. Spike with end cap: used to connect to the spike receptor on the AC container

This document describes the marketing clearance (K151368) for the Terumo BCT Spectra Optia Apheresis System, including specific modifications to the Exchange Set and the introduction of a Wireless Network Solution. However, the provided document does not contain the detailed study information typically associated with AI/ML device evaluations. Instead, it focuses on the performance testing of the physical device components and the wireless connectivity.

Therefore, for aspects related to AI/ML (like sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.), the document does not provide the requested information. The Spectra Optia Apheresis System is an automated, centrifugal, blood component separation device, which is a physical medical device, not an AI/ML algorithm or software. It would not typically involve the kinds of studies requested in the prompt (e.g., human reader improvement with AI, standalone algorithm performance).

Here's an attempt to answer the questions based only on the provided document. Many fields will be marked as "Not Applicable" or "Not Provided" because the document focuses on a non-AI/ML device.

1. Table of acceptance criteria and the reported device performance

Ask a specific question about this device

The Spectra Optia Apheresis System, a blood component separator, may be used to perform therapeutic plasma exchange.

The Spectra Optia Apheresis System, a blood component separator, may be used to perform Red Blood Cell Exchange (RBCX) procedures for the transfusion management of Sickle Cell Disease in adults and children.

The Spectra Optia Apheresis System is comprised of three subsystems: the apheresis machine (or equipment), embedded software, and a single-use disposable blood tubing set. The modifications described in this submission enhance the disposable set's manufacturability and usability during therapeutic plasma and red blood cell exchange procedures.

Spectra Optia Machine and Embedded Software: The Spectra Optia Apheresis System is an automated, centrifugal, blood component separation device that uses pumps, valves and sensors to control and monitor a disposable, plastic extracorporeal circuit, during therapeutic apheresis procedures. The system's embedded software controls pump flow rates and centrifuge speed to establish and maintain the required plasma/cellular interface, and ensure patient safety.

Disposable Blood Tubing Set: The disposable Spectra Optia Exchange Set (Catalog No. 10220) is provide sterile and is intended for single-use only. The set is invasive, in that patients are connected to the disposable using a needle or other blood access device (catheter, port, etc.). The patient's blood comes into direct contact with the biocompatible plastics that comprise the set. Key components of the set include the [1] centrifuge channel (inside which the patient's blood is separated into its components), [2] the plastic cassette that integrates the tubing/defines the fluid path for ease of installation and use and, [3] the pre-attached waste bag into which the diseased blood component is collected.

The provided text is a 510(k) Summary for the Spectra Optia Apheresis System. This document describes modifications made to the disposable blood tubing set of an already cleared apheresis system and aims to demonstrate substantial equivalence to its predicate device. It is not a study proving a device meets acceptance criteria in the typical sense of a clinical trial for an AI/ML diagnostic device with performance metrics like sensitivity/specificity.

The "acceptance criteria" here relate to the functional equivalence and safety of the modifications to the disposable blood tubing set, ensuring they do not negatively impact the established performance of the Spectra Optia Apheresis System itself.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present "acceptance criteria" in a typical quantitative clinical performance metric format (e.g., sensitivity, specificity). Instead, the criteria are implicitly tied to maintaining the functional equivalence, safety, and usability of the device after modifications. The "performance" reported is related to how the modifications themselves behave and if they introduce any new risks or alter the system's core function.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a "test set" in the context of diagnostic accuracy. However, for the simulated-use testing of the IV Filter, quantitative data is provided: "length of air measured in the AC line averaged 13.3 inches (S.D.: 1.3 inches)" for the unmodified set, and "0 inches in the modified set." The number of trials or "samples" for this specific measurement is not provided. General "comprehensive verification testing" and various "evaluations" are mentioned, but without specific unit counts.
• Data Provenance: The document does not specify the country of origin for the reported testing or if it was retrospective or prospective. It describes testing performed to support regulatory submission for a device manufactured by Terumo BCT in Lakewood, Colorado, USA.

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 document. The "ground truth" here is based on engineering verification and simulated-use testing outcomes (e.g., presence/absence of air, functional performance of a port), not expert consensus on medical images or patient diagnoses.

4. Adjudication Method for the Test Set

This is not applicable. The assessments are based on direct measurements, observations, and engineering tests of the modified components and their interaction with the system, not on adjudicated interpretations by multiple reviewers.

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 is not applicable. This document describes modifications to an apheresis system's disposable tubing set, not an AI/ML diagnostic device, and therefore no MRMC study or AI assistance evaluation was performed.

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

This is not applicable. This device is an apheresis system, which is a hardware and embedded software system for blood processing, not a standalone AI algorithm. While it has "embedded software" that controls functions, the evaluation is on the hardware modifications (e.g., a filter, a needleless port, a vent bag) and their functional impact.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluations described are based on:

• Physical Measurements and Observation: For example, measuring the length of air in the AC line.
• Engineering and Functional Testing: Verifying that mechanical designs work as intended, and that new components do not impede existing functions or introduce new risks.
• Biocompatibility Testing: Ensuring materials are safe for patient contact.
• Sterility, Packaging, and Shelf Life Testing: Standard regulatory requirements for medical devices.

8. The Sample Size for the Training Set

This is not applicable. As a hardware device with embedded control software, there is no "training set" in the context of an AI/ML algorithm that learns from data. The software controls pre-defined processes.

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

This is not applicable for the reasons stated in point 8.

Ask a specific question about this device

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.

Ask a specific question about this device

The Spectra Optia Apheresis System, a blood component separator, is intended for use in therapeutic apheresis applications, and may be used to perform Red Blood Cell Exchange, Depletion, and Depletion/Exchange (RBCX) procedures.

The Spectra Optia Apheresis System, a blood component separator, can be used to perform Red Blood Cell Exchange (RBCx) procedures for the transfusion management of Sickle Cell Disease in adults and children.

The Spectra Optia Apheresis System is a centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems: (1) the apheresis machine itself (centrifuge, pumps, valves. etc.). (2) sterile, single-use, disposable tubing sets and, (3) embedded software.

Modifications to the disposable Exchange Set and embedded software have been made to enable Red Blood Cell Exchange (RBCx) procedures on the Spectra Optia system.

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

Spectra Optia® Apheresis System for Red Blood Cell Exchange (RBCx)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document mentions "a prospective, multi-center, single-arm, open-label study," which indicates a clinical study with real patients, but the exact number of patients is not provided.
• Data Provenance: The study was a "prospective, multi-center" clinical study. This implies data was collected from multiple clinical sites (likely within the US, given the FDA submission) actively as the study progressed (prospective).

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

• The concept of "experts establishing ground truth" as seen in diagnostic imaging for example, is not directly applicable here. The device is an apheresis system for treatment, not a diagnostic device.
• The "ground truth" for the primary endpoint (achieving target HbS) would be derived from objective lab measurements of the patients' HbS levels before and after the RBCx procedure, based on the physician's prescription. The "ground truth" for safety would be identified by clinical observation and reporting of adverse events by the clinical staff involved in the study.

4. Adjudication Method for the Test Set

• Adjudication methods (like 2+1, 3+1) are typically used in studies where there's subjectivity in interpreting results (e.g., image reading). This device's primary endpoints (HbS levels, fluid balance, adverse events) are objective measurements or clinical observations. Therefore, a specific "adjudication method" in that sense is not mentioned or likely applicable. The study's design (multi-center, open-label) implies standardized protocols for data collection and reporting.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This device is an automated apheresis system and does not involve "human readers" or "AI assistance" in the typical sense of a diagnostic or interpretive task. The comparison was between the modified Spectra Optia system and its predicate device (COBE Spectra), both being automated systems.

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

• The device itself is an "algorithm only" in the sense that it is an automated system with embedded software. The clinical study evaluated the performance of this automated system in a real-world clinical setting without direct human intervention in the core RBCx procedure execution by the device itself (though human operators initiate and monitor the procedure).
• The comparison against the predicate COBE Spectra system (also an automated system) effectively acts as a standalone performance comparison between two automated systems.

7. The Type of Ground Truth Used

• Clinical Outcomes/Measurements: The ground truth was based on objective clinical measurements and outcomes.
  • HbS Levels: Objective laboratory measurements of hemoglobin S in the patients' blood, compared against physician-prescribed targets.
  • Safety Data: Clinical observation and reporting of adverse events (SAEs, UADEs).
  • Hematocrit Targets & Fluid Balance: Objective physiological measurements taken during the procedures.

8. The Sample Size for the Training Set

• This device is not a machine learning or AI model in the common sense that requires a "training set" for model development. The software algorithms are likely rule-based or control-system based.
• The software was "verified through a variety of verification testing; including Functional, Reliability, Usability, Exploratory, and Robustness." This indicates traditional software engineering testing rather than machine learning training. Therefore, a "training set" in the context of data for model learning is not applicable or stated.

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

• As concluded in point 8, there isn't a "training set" in the typical machine learning sense for this device. The software was developed using standard engineering practices, and its performance was then validated through non-clinical verification and a prospective clinical study.

Ask a specific question about this device