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The XTRA Autotransfusion System (including the XTRA bowl set) is indicated for intraoperative recovery of blood, washing of blood collected in the postoperative 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
• Urology

The XTRA Autotransfusion System (with XTRA Bowl Sets) are single use sterile devices made of plastic materials (mainly PVC) and they should be used in combination with the XTRA autologous blood separation equipment unit (XTRA Equipment) for preoperative sequestration, intraoperative cell salvage, and/or postoperative cell salvage, aimed at autotransfusion.

The XTRA Autotransfusion System (with XTRA Bowl Sets) consist of a disposable bowl pre-connected with a system of tubing lines and bags, the autologous blood is collected from the field by mean of a vacuum source (vacuum pump provided into the equipment), then the blood is pumped with a roller pump (provided into the equipment) into the bowl separation chamber and centrifuged. Because of centrifugal force the blood components are separated and the RBC, PPP and PRP are collection bags while the undesired elements (lysed cells, residuals, water, etc.) are discarded into a waste bag. The blood processed and collected in the bags is then reinfused to the patient through gravity. The system does not provide any mechanical means of reinfusing the product.

The XTRA Autotransfusion System (with XTRA Bowl Sets) are a modified version of the disposables currently marketed in the XTRA autotransfusion system (K101586).

This document describes the XTRA Autotransfusion System, a medical device for blood processing in surgical settings. However, it does not contain the information requested about acceptance criteria and a study proving the device meets those criteria, particularly for an AI-enabled device.

The provided text is a 510(k) premarket notification for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive de novo clinical trials with specific acceptance criteria as might be seen for novel AI/ML devices.

Here's why the requested information cannot be extracted from this document:

• No Acceptance Criteria or Performance Metrics: The document does not list specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy, precision, etc.) for the device's performance. It primarily focuses on the technical characteristics and intended use being equivalent to a predicate device.
• No "Study" in the traditional sense for AI/ML: The document states, "No clinical testing was conducted in support of the XTRA Autotransfusion System (with XTRA Bowl Sets), as the indications for use and technical characteristics are equivalent to those of the predicate device, which has been on the market for several years with proven safety and efficacy of use." This explicitly states that no clinical study was performed to demonstrate performance against acceptance criteria.
• Device Type: The device is an "Autotransfusion apparatus," which is a physical medical device (bowl sets, tubing, bags) for processing blood. It is not an AI/ML-enabled device. Therefore, questions about training sets, test sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to this type of device.

In summary, the provided text does not contain the information required to answer your specific questions regarding acceptance criteria and a study proving an AI-enabled device meets those criteria. The document is a regulatory submission for a non-AI medical device demonstrating substantial equivalence.

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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
• Urology

XTRA Autotransfusion System consists of hardware and disposables. It is the next generation of the Sorin autotransfusion device family. The main elements of the hardware include the centrifuge, blood pump, automatic clamps, control and monitoring sensors, and an user interface (display panel and keyboard). The main modifications to the disposables are the elimination of the bowl snap on bayonet fitting system to fix the device into the centrifuge, the elimination of the silcone bayon inting bystem to and the newly designed system that allows the set up of the disposable set to simplify the installation of disposable.

Here's a breakdown of the acceptance criteria and study information for the XTRA Autotransfusion System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria for performance metrics. Instead, the basis for equivalence is primarily a comparison to a predicate device (Dideco ELECTA) and compliance with general safety standards.

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

• Test Set Sample Size: The document does not specify the sample size for the "in vitro test results." It generally refers to "testing" and "the study."
• Data Provenance: The studies were in vitro (laboratory-based testing). The country of origin for the data is not explicitly stated, but the submitter is Sorin Group Italia S.r.l., suggesting the tests were likely conducted in Italy or a contracted facility. The studies appear to be prospective in nature, as they were conducted to support the 510(k) submission.

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

This information is not applicable to the provided document. The studies described are in vitro performance tests and biocompatibility tests, not studies that would require human expert interpretation of device output to establish ground truth in the way a diagnostic imaging device might. Ground truth was established through validated laboratory testing procedures against established specifications and comparison to the predicate device's known characteristics.

4. Adjudication Method for the Test Set

This is not applicable. Since the device is an autotransfusion system and the testing described is primarily in vitro performance and biocompatibility, there is no "adjudication method" in the context of human interpretation of results (e.g., as in a clinical trial or image reading study). The results were likely assessed against pre-defined engineering and safety specifications by qualified testing personnel.

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

No, an MRMC comparative effectiveness study was not mentioned or performed. This type of study is typically relevant for diagnostic devices where human readers interpret output (e.g., images), and the AI's impact on reader performance is evaluated. The XTRA Autotransfusion System is a therapeutic/surgical support device.

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

Yes, the "in vitro test results" and biocompatibility tests can be considered standalone performance assessments. These tests evaluate the device's inherent characteristics and functionality (electrical, electromagnetic, performance specifications, and material interactions) without specific "human-in-the-loop" interaction directly influencing the measured outcomes for these particular tests. The device is a piece of medical equipment, and its performance is assessed based on engineering specifications and biological safety.

7. The Type of Ground Truth Used

The ground truth used for these studies consisted of:

• Established Specifications: For biocompatibility (e.g., limits for hemolysis, cytotoxicity) and engineering performance (electrical, electromagnetic, mechanical parameters).
• Predicate Device Characteristics: For the in vitro performance study, the Dideco ELECTA's characteristics served as the comparative "ground truth" or benchmark for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. The XTRA Autotransfusion System is a physical medical device, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The device's design, engineering, and manufacturing would be based on established principles and prior experience, but not a data-driven training set.

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

This information is not applicable for the same reason as point 8.

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