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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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