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The XTRA Autotransfusion System is indicated for intraoperative recovery of blood, washing of blood collected in the postoperative period, and preoperative sequestration (with indirect patient connection). Typical clinical applications of autotransfusion include the following surgical specialties: Cardiovascular, Orthopedics, Thoracic, Transplant Surgery, Emergency (Trauma), Neurosurgery, Obstetrics and gynecology, and Urology.

XTRA is an Autotransfusion System designed to recover shed blood during intraoperative and postoperative procedures and for collection of platelet poor plasma (PPP) and platelet rich plasma (PRP) in preoperative procedures.

It is a software-controlled device provided with disposable and hardware elements that include the following major components: master, driving actuators (pump, centrifuge, clamps, pump loop ejector, cover lock), control and monitoring sensors, and an user interface (display panel and keyboard).

The modified device is a software upgraded version (SW 1.05.0) of the unmodified device (SW 1.02.0).

The current SW release 1.05.0 has been implemented to improve device's performances and to respond to feedback/indications coming from the users in the field. Other minor changes have been also implemented for user convenience and some bugs have been fixed. The main performances improvement implemented with the new SW upgrade consists of the introduction of a new factory protocol (Pfat) that has been optimized to eliminate non emulsified fat from the processed blood. The labeling and the instructions for use have been generally updated to include Pfat features as well as to reflect the modifications, where applicable.

Here's a breakdown of the acceptance criteria and study information for the XTRA Autotransfusion System based on the provided text:

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 size used for the in vitro test set. It only states that "Comparative tests were performed according to internal methods developed by the manufacturer."

The data provenance is internal to the manufacturer (Sorin Group Deutschland GmbH) as the tests were performed "in vitro" and according to their "internal methods." The country of origin of the data is implicitly Germany, where the submitter is located. The tests were prospective in vitro experiments.

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

Not applicable. This device is an autotransfusion system, and the reported tests are in vitro performance evaluations of its processing capabilities (fat removal and washing performance), not diagnostic interpretations requiring expert human review. The "ground truth" for these tests would be objective measurements of the device's output (e.g., amount of fat removed, effectiveness of washing).

4. Adjudication Method for the Test Set

Not applicable. As noted above, the tests are in vitro performance evaluations, not diagnostic image interpretations that would require adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The study performed was an in vitro performance test of the device itself, comparing its performance to an unmodified version of the device, rather than assessing 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, the studies described are standalone in vitro performance tests of the device (which includes software) without human intervention in the performance evaluation itself. The device is a software-controlled system, and its "algorithm" (the software upgrade to version 1.05.0) was tested for its impact on fat removal and washing performance.

7. The Type of Ground Truth Used

The ground truth used for these in vitro performance tests would be objective measurements and laboratory results related to the device's functional outputs, specifically:

• For "fat removal performance": objective measurements of the presence or absence of non-emulsified fat in processed blood.
• For "washing performance": objective measurements of the effectiveness of the washing process (e.g., removal of plasma, waste products).

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of device performance testing. The device is a "software upgraded version" of an existing system, and the reported tests are in vitro performance validations of this upgrade. There's no indication that machine learning or AI models requiring a training set were developed or validated in this submission. The software upgrade focused on "improving device's performances and to respond to feedback/indications coming from the users in the field."

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

Not applicable, as no training set for a machine learning model is mentioned in the provided text.

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