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The Haemonetics® Cell Saver® Elite®+ Autotransfusion System and its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping the processed red blood cells to a product bag. The intended use of the Sequestration Protocol is to collect an autologous, preoperative, plasma product for reinfusion to the same patient within the recommended time of the American Association of Blood Banks (AABB), 9th Edition.

The subject of this Traditional 510(k) is the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System 7.3 (AQ) software update which allows users the ability to manually control the cell salvage procedure through manual mode, quick transfer and decreased minimum wash volume. The Cell Saver Elite/Elite+ System consists of a single use disposable set and reusable equipment. One disposable set is used throughout an individual patient's surgical procedure and then discarded. The Cell Saver Elite/Elite+ System utilizes a unique bowl processing kit, but is compatible with Haemonetics standard reservoirs and A&A lines. The collected blood is processed through a centrifugal separation chamber (bowl) where RBCs are concentrated and then washed, removing unwanted substances such as hemolized cells, anticoagulant and irrigating fluids. The washed RBC product is available for return via a product bag to the patient. The Elite+ System is designed to perform plasma sequestration using the autotransfusion disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion.

The provided text is a 510(k) Summary for the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) software update. It describes the device, its intended use, and the non-clinical testing performed to demonstrate substantial equivalence to a predicate device. However, this document does not contain information about the acceptance criteria and study design for proving the device meets those criteria from an AI/ML perspective.

The changes in this 510(k) are related to a software update (version 7.3 AQ) for an autotransfusion system, specifically adding "manual mode, quick transfer and decreased minimum wash volume" features. This device processes blood (concentrating and washing red blood cells) rather than interpreting medical images or data using AI/ML algorithms.

Therefore, many of the requested items (sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone AI performance, type of ground truth for AI, how ground truth for training set was established) are not applicable to this type of device and submission.

The document focuses on:

• Software Verification: To verify the new software revision.
• Functional Testing: To validate washout performance (a physical function of the blood processing).
• Usability Testing: To validate operational needs and usability.

These tests are standard for a medical device software update and functional changes, but they do not involve AI/ML performance evaluation as typically understood in the context of diagnostic or prognostic AI systems that require ground truth, expert readers, and rigorous statistical analysis of AI model performance.

In summary, this document is for a medical device software update, not an AI/ML device. Therefore, it does not provide the information requested about AI/ML acceptance criteria and study paradigms.

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The Haemonetics Cell Saver® Elite®+ Autotransfusion System and its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.

The intended use of the Sequestration Protocol is to collect an autologous, preoperative, platelet rich plasma product for reinfusion to the same patient within 6 hours of collection.

The Cell Saver Elite/Elite+ System is intended to be used by trained physicians, operating room nurses or floor nurses, anesthesia technicians and autotransfusion service providers to provide intra-operative and post-operative blood salvage for surgical procedures with medium to high blood loss including, but not limited to CABG, AAA, joint replacement, spinal, trauma and transplant surgeries.

The Cell Saver Elite/Elite+ System is intended to be used by trained physicians, operating room nurses or floor nurses, anesthesia technicians and autotransfusion service providers to provide intra-operative and post-operative blood salvage for surgical procedures with medium to high blood loss including, but not limited to CABG, AAA, joint replacement, spinal, trauma and transplant surgeries.

The Cell Saver Elite/Elite+ System consists of a single use disposable set and reusable equipment. One disposable set is used throughout an individual patient's surgical procedure and then discarded. The Cell Saver Elite/Elite+ System utilizes a unique bowl processing kit, but is compatible with Haemonetics standard reservoirs and A&A lines.

The collected blood is processed through a centrifugal separation chamber (bowl) where RBCs are concentrated and then washed, removing unwanted substances such as hemolized cells, anticoagulant and irrigating fluids. The washed RBC product is available for return via a product bag to the patient.

The Elite/Elite+ System is designed to perform plasma sequestration using the autotransfusion disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion.

The subject of this Special 510(k) is the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System software and hardware to enable use of wired and wireless connectivity.

This document describes the regulatory approval (K162423) for the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System with added wired and wireless connectivity features. The approval is based on demonstrating substantial equivalence to a predicate device (K160197).

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on the safety and performance of the added connectivity features and modifications to the user interface hardware. The acceptance criteria essentially revolve around demonstrating that these changes do not compromise the existing performance requirements of the autotransfusion system and comply with relevant standards.

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

The document does not explicitly state the "sample size" in terms of number of devices or number of test cases run for each test. The non-clinical testing summary simply lists the tests conducted.

The data provenance is from non-clinical testing performed by the manufacturer, Haemonetics Corporation, as part of their 510(k) submission. This is internal testing, not patient data, and is thus prospective in the sense that it was performed specifically for this submission. The country of origin for the data generation would be where Haemonetics conducted their internal R&D and testing.

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

This information is not applicable in the context of this 510(k) submission for device modifications. No "ground truth" based on expert medical opinion (like clinical diagnosis) was established or used for the technical performance tests (EMC, electrical safety, wireless coexistence, software validation). These tests rely on engineering standards and functional verification.

4. Adjudication Method for the Test Set

This is not applicable. The tests performed (EMC, electrical safety, wireless coexistence, software validation) are objective engineering and software verification tests, not subjective interpretations requiring adjudication.

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 submission is for modifications to an autotransfusion system, a medical device that processes blood. It does not involve "human readers" or "AI assistance" in the context of interpreting medical images or making diagnostic decisions, which is typically where MRMC studies are conducted.

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

This is not applicable. The device is an autotransfusion system, not an algorithm performing a standalone diagnostic or interpretive function. The "software validation" was for the embedded software controlling the device's functionality and connectivity, which operates as part of the overall system with human operators.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance tests was based on engineering specifications, regulatory standards (e.g., IEC 60601-1-2, IEC 60601-1), and the defined functional requirements of the device. For example, for EMC, the ground truth is compliance with the specified limits in the standard. For wireless coexistence, the ground truth is the device operating without unacceptable interference. For software, the ground truth is the software performing as designed according to its requirements.

8. The Sample Size for the Training Set

This is not applicable. This device is not an AI/ML system that undergoes a "training phase" with a training set of data in the typical sense (e.g., for image recognition or predictive models). The software validation refers to the testing of the developed software against its requirements.

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

This is not applicable for the reasons stated in point 8. The device's software is developed through standard software engineering practices and validated against pre-defined functional and performance requirements.

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The Haemonetics Cell Saver® Elite® Autotransfusion System and its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.

The intended use of the Sequestration Protocol is to collect an autologous, preoperative, platelet rich plasma product for reinfusion to the same patient within 6 hours of collection.

The Cell Saver Elite System is intended to be used by trained physicians, operating room nurses or floor nurses, anesthesia technicians and autotransfusion service providers to provide intraoperative and post-operative blood salvage for surgical procedures with medium to high blood loss including, but not limited to CABG, AAA, joint replacement, spinal, trauma and transplant surgeries.

The subject of this Special 510(k) is the Haemonetics Cell Saver Elite Autotransfusion System fat washing protocol and modified 70mL bowl algorithm.

The Cell Saver Elite System consists of a single use disposable set and reusable equipment. One disposable set is used throughout an individual patient's surgical procedure and then discarded. The Cell Saver Elite System utilizes a unique bowl processing kit, but is compatible with Haemonetics standard reservoirs and A&A lines.

The collected blood is processed through a centrifugal separation chamber (bowl) where RBCs are concentrated and then washed, removing unwanted substances such as hemolized cells, anticoagulant and irrigating fluids. The washed RBC product is available for return via a product bag to the patient.

The Elite System is designed to perform plasma sequestration using the autotransfusion disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion.

Here's a breakdown of the acceptance criteria and study information for the Haemonetics Cell Saver Elite Autotransfusion System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance (for Fat Washing Protocol):

Note: (**) refers to data from the reference device Sorin Xtra, cited as "Fat removal during cell salvage - An optimized program in the XTRA® autotransfusion device" by Timo Seyfried, MD, Michael Gruber, MD; Lilith Haas; Emil Hansen, PhD, MD 13th ECOPEAT Vienna - Austria 2013.*
Note: () for the subject device indicates "depending on bowl size used".*

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

• Sample Size: The document does not explicitly state the sample size used for the performance tests (functional testing and software validation). It lists several test reports by number (e.g., TR-SOF-100562, TR-OTH-100649), but these reports themselves are not included in the provided text.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only states that "non-clinical performance testing was submitted."

3. Number of Experts and Qualifications for Ground Truth:

• This information is not provided in the document. The testing described appears to be primarily technical and functional validation against predefined performance metrics for a medical device rather than studies requiring expert human interpretation of medical images or patient data.

4. Adjudication Method for the Test Set:

• This information is not applicable and not provided. The testing described is against established performance requirements and is not a clinical study requiring adjudication of expert interpretations.

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

• No MRMC comparative effectiveness study is mentioned. The submission is for a modification to an existing autotransfusion system, focused on technical performance improvements rather than reader interpretation.

6. Standalone Performance Study (Algorithm Only):

• The document implies standalone performance studies were conducted for the device's functionality. Table 1 "Summary of Performance Studies" lists "Software Validation" and "Functional Testing" with corresponding report numbers and "Test Intent" that demonstrate the device (or its software components and new features like fat washing protocol and modified 70mL bowl algorithm) met performance requirements. The results are simply "Passed," indicating the algorithm's performance in achieving the specified criteria.

7. Type of Ground Truth Used:

• The ground truth used for the performance studies appears to be based on objective, quantitative measurements related to blood processing parameters. For example:
  • Hematocrit (HCT%)
  • Red Blood Cell (RBC) Recovery
  • Plasma Hemoglobin (HgB) Washout
  • Heparin Washout
  • Albumin Washout
  • Fat Removal
• These are physical and chemical properties of blood that can be measured directly by laboratory methods, establishing a clear objective ground truth for the device's performance in processing blood.

8. Sample Size for the Training Set:

• The document does not provide details about a "training set" as this device is not an AI/ML algorithm that typically requires a large training dataset in the same way. The mentioned "Software Validation" and "Functional Testing" refer to verification and validation activities for the device's software and hardware, where "training" in the context of machine learning is not directly applicable.

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

• As mentioned above, the concept of a "training set" and its associated ground truth establishment is not relevant to this type of device submission based on the provided information. The validation focuses on ensuring the device meets pre-defined performance specifications for blood processing.

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The Haemonetics Cell Saver® Elite™ Autotransfusion System and its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. The intended use of the Sequestration Protocol is to collect an autologous, preoperative, platelet rich plasma product for reinfusion to the same patient within 6 hours of collection.

The Cell Saver Elite Autotransfusion System is an evolution of the previously cleared Haemonetics Cell Saver Elite Autotransfusion System. The Cell Saver Elite System consists of a single use disposable equipment. One disposable set is used throughout an individual patient's surgical procedure and then discarded. The Cell Saver Elite System utilizes a unique bowl processing kit, but is compatible with Haemonetics standard reservoirs and A&A lines. The collected blood is processed through a centrifugal separation chamber (bowl) where RBCs are concentrated and then washed, removing unwanted substances such as hemolized cells, anticoagulant and irrigating fluids. The washed RBC product is available for return via a product bag to the patient. The Elite System is designed to perform plasma sequestration disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion. The changes from the previously cleared Cell Saver Elite to the subject Cell Saver Elite system include a software change and a mechanical change to the pinch valve disposable sensor detection system.

The Haemonetics Cell Saver Elite Autotransfusion System is an autotransfusion apparatus. The data provided includes non-clinical performance testing which focuses on processing efficiency and product characteristics of blood products.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (number of tests or units of blood) used for each in-house laboratory evaluation. It states "Test data demonstrates that the device and resultant blood products met all clinical and performance requirements". The data provenance is "In-house Laboratory Evaluation," implying the data was generated within Haemonetics Corporation and is retrospective for the purpose of this 510(k) submission, as it refers to testing submitted with a previous 510(k) in 2010.

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 the non-clinical performance studies described. The ground truth for these studies relies on instrumental measurements and validated laboratory protocols for determining blood product characteristics (e.g., hematocrit, concentration of substances, cell recovery). There is no mention of human expert evaluation for establishing ground truth in these technical performance tests.

4. Adjudication Method for the Test Set

Not applicable. As described above, the ground truth is based on laboratory measurements and established performance criteria, not on expert consensus or adjudication.

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 autotransfusion system, a medical device that processes blood. It is not an AI-powered diagnostic or imaging device that would involve human readers or AI assistance in interpretation.

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

The performance studies described ("In-house Laboratory Evaluation") are essentially standalone performance evaluations of the device's ability to process blood and achieve specific product characteristics. The device operates automatically based on programmed protocols.

7. The Type of Ground Truth Used

The ground truth for the performance studies was established through:

• Laboratory Measurements: Quantifiable parameters like hematocrit, heparin concentration, free hemoglobin concentration, and red blood cell recovery.
• Established Performance Criteria/Thresholds: Pre-defined numerical targets or ranges (e.g., hematocrit 40-60%, washout ≥95%) that the device's output should achieve.

8. The Sample Size for the Training Set

Not applicable. The device is a physical medical device (autotransfusion system) rather than an algorithm or AI model that requires a training set in the conventional sense. Its performance is based on engineering design and validated physical/chemical processes.

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

Not applicable, as there is no training set for this type of medical device. The "ground truth" for its operation is the set of physical and biochemical principles it utilizes for blood processing.

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The Haemonetics Cell Saver® Elite™ Autotransfusion System and its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient. The intended use of the Sequestration Protocol is to collect an autologous, preoperative, platelet rich plasma product for reinfusion to the same patient within 6 hours of collection.

The Cell Saver Elite Autotransfusion System is an evolution of the Haemonetics Cell Saver 5 Autologous Blood Recovery System. The Cell Saver Elite System consists of a single use disposable equipment. One disposable set is used throughout an individual patient's surgical procedure and then discarded. The Cell Saver Elite System utilizes a unique bowl processing kit, but is compatible with Haemonetics standard reservoirs and A&A lines. The collected blood is processed through a centrifygal separation chamber (bowl) where RBCs are concentrated and then washed, removing unwanted substances such as hemolized cells, anticoagulant and irrigating fluids. The washed RBC product is available for return via a product bag to the patient. The Elite System is designed to perform plasma sequestration disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion. The Cell Saver Elite system is designed to perform the same types of procedures as the Cell Saver 5 system, utilizing very similar disposable sets. The primary changes from the Cell Saver 5 to the Cell Saver Elite systems include a modernized graphical user interface with a touch screen display, barcode data capture capability to simplify data entry, and the integration of an onboard vacuum system to provide regulated vacuum to the collection reservoir.

Here's an analysis of the acceptance criteria and supporting studies for the Haemonetics Cell Saver Elite Autotransfusion System, based on the provided document:

Acceptance Criteria and Device Performance Study for Haemonetics Cell Saver Elite Autotransfusion System

1. Table of Acceptance Criteria and Reported Device Performance

• Heparin Washout ≥95%
• Free Hemoglobin Washout ≥95%
• Red Blood Cell Recovery ≥80% | Conclusion: Data met Acceptance Criteria |
  | In-house Laboratory Validation of Platelet Sequestration Protocol Using the Cell Saver Elite
  (Protocol TR-CLN-100201) | No formal acceptance criteria; characterization of the product. | Conclusion: The platelet rich plasma that is produced meets the threshold of three (3) times the incoming platelet count of the whole blood. |
  | In-house Laboratory Evaluation of Processing Efficiency and Product Characteristics using Pools without Lysate
  (Protocol TR-CLN-100049) | - Final product hematocrit of 40-60%
• Heparin Washout ≥95%
• Free Hemoglobin Washout ≥95%
• Red Blood Cell Recovery ≥80% | Conclusion: Data met Acceptance Criteria. The data above indicate the processed RBC product data from all three bowl types exceeded the acceptance criteria in terms of Hematocrit, RBC Recovery and Washout. The RBC recovery data was, on average 12% higher than the RBC Recovery derived from procedures using pools with high levels of free hemoglobin. |

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

The provided document does not explicitly state the sample sizes used for the test sets in the non-clinical laboratory studies (TR-CLN-100177, TR-CLN-100201, TR-CLN-100049).

The data provenance is internal in-house laboratory evaluations. There is no information regarding the country of origin of the data beyond "in-house laboratory" or whether it was retrospective or prospective. Given it is laboratory testing for performance characterization, it would typically be prospective testing conducted for the purpose of the submission.

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 are described as "in-house laboratory evaluations" characterizing device performance, not assessments based on expert-derived ground truth from a clinical data set. The ground truth for these tests would be the measured properties of the processed blood products (e.g., hematocrit, washout percentages), which are quantifiable laboratory values.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is typically relevant for studies where subjective expert assessment is used to establish ground truth or evaluate a device's diagnostic output. Since these are laboratory performance studies measuring objective parameters of blood processing, an adjudication method is not applicable and therefore not mentioned. The "ground truth" for these studies is the direct measurement of the physical and chemical properties of the blood components.

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

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The document describes non-clinical laboratory performance testing of the device itself and a comparison of its characteristics to a predicate device. It does not involve human readers evaluating output or comparing human performance with and without AI assistance.

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

The studies described are standalone performance studies of the device (Haemonetics Cell Saver Elite system) itself, focusing on its ability to process blood and produce a specific output (e.g., washed red blood cells, platelet-rich plasma). The device itself operates autonomously in its processing functions, so its performance is inherently "algorithm only" or "device only" in terms of its processing capabilities. There is no human interaction during the blood processing and characterization that would alter the device's fundamental performance metrics.

7. Type of Ground Truth Used

The ground truth used for these performance studies is objective, quantitative laboratory measurements of the processed blood products. This includes:

• Final product hematocrit
• Heparin Washout percentage
• Free Hemoglobin Washout percentage
• Red Blood Cell Recovery percentage
• Platelet count in platelet-rich plasma

These are direct physical and chemical measurements rather than subjective expert consensus, pathology reports, or patient outcomes.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. The Haemonetics Cell Saver Elite Autotransfusion System is a medical device that performs physical blood processing through centrifugation and washing. It is not an AI/ML-based diagnostic or prognostic algorithm that requires a "training set" in the computational sense. Its design and performance are established through engineering, physics, and validation testing, not machine learning training.

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

This information is not applicable. As stated above, the device does not use a training set as it is not an AI/ML system. Its "ground truth" for development and validation is based on established principles of blood processing, and performance is verified through rigorous laboratory testing against predefined specifications.

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