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The Aptus 18Fr HeliFX Aortic Securement System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The 18Fr HeliFX System is indicated for use in patients whose endovascular grafts have exhibited migration or endoleak, or are at risk of such complications, in whom augmented radial fixation and/or sealing is required to regain or maintain adequate aneurysm exclusion.

The Aptus 18Fr HeliFX Aortic Securement System comprises the EndoAnchor with EndoAnchor Cassette, the 18Fr HeliFX Applier, and the 18Fr HeliFX Guide.

This 510(k) summary describes a medical device, the Aptus 18Fr HeliFX Aortic Securement System, and states its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study designed to prove the device meets specific performance criteria in terms of accuracy or efficacy against a defined ground truth, especially not in the context of an AI/ML algorithm.

Here's why and what information is missing:

• No AI/ML Algorithm: The document describes a physical medical device (an endovascular suturing system) for mechanical fixation and sealing of aortic grafts. It is not an AI/ML powered device. Therefore, concepts like AI performance, test sets, training sets, ground truth establishment by experts, adjudication, or MRMC studies do not apply.
• Focus on Substantial Equivalence: The primary goal of this 510(k) summary is to demonstrate that the new Aptus 18Fr HeliFX Aortic Securement System is "substantially equivalent" to a previously cleared predicate device (Aptus HeliFX Aortic Securement System per K102333). This typically involves showing similar materials, method of operation, and intended use, and that any differences do not raise new questions of safety or effectiveness.
• "Data Relied Upon" is Different: The "Data relied upon for substantial equivalence" section lists performance and simulated use testing, mechanical integrity testing, endograft compatibility testing, sterilization, biocompatibility, and shelf-life evaluations. These are standard engineering and biological tests for a physical medical device, not performance metrics for an AI algorithm.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, and AI/ML performance because the provided document does not pertain to an AI/ML device and does not contain that type of information.

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