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The EMBOL-X Intra-aortic Filter is indicated for use with the EMBOL-X Aortic Cannula in first time, nonemergent cardiac surgery procedures to capture and remove particulate emboli from the ascending aorta and heart during and following cross clamp removal in patients aged 18 years and older.

The EMBOL•X® Intra-aortic Filter device consists of three primary components: (1) a distal heparin-coated mesh filter, mounted onto a flexible frame to form a filter basket for particulate emboli capture and retention; (2) a locking cartridge housing for attachment to the EMBOL•X Aortic Cannula side port, permitting access to the aorta and to ensure correct orientation of the filter during use; and (3) a proximal syringe-like plunger mechanism to deploy and withdraw the distal basket into and from the aorta, via the cannula, during surgery. The filter is introduced surgically into the aorta via the previously placed cannula, and particulates are captured and removed as blood passes through the filter basket. The filter may remain in situ for up to 60 minutes. The EMBOL•X Intra-aortic Filter utilizes conventional medical grade materials and processes, and is provided packaged, labeled, and sterile, intended for single-use.

I am sorry, but the provided text is for a 510(k) summary for a medical device (EMBOL•X® Intra-Aortic Filter), which is a physical device, not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, ground truth establishment, expert adjudication, or MRMC studies, are not applicable.

The document discusses the device's technical characteristics, non-clinical test results (biocompatibility, in-vitro, pre-clinical), and clinical study results from a post-market European Registry to support its safety and effectiveness for expanded indications. These studies confirm the device meets established internal performance specifications and satisfies relevant external standards and FDA guidance.

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1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a tabular format with specific numerical targets. However, the performance is described in terms of safety and effectiveness, drawing comparisons to a predicate device study.

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