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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 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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