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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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