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The Element Vascular Access System is indicated for the introduction of therapeutic or diagnostic devices into the vasculature.

The Element Vascular Access System is a medical device system designed to provide a conduit for introduction of therapeutic devices to the peripheral, coronary, and neurovascular anatomy. This device is a three-component system comprised of the BMX81 Delivery Catheter, Penumbra (Neuron 5F) Select Catheter, and a Dilator. The BMX81 Delivery Catheter can be used individually with a 0.038 in [0.97 mm] guidewire or together with the Neuron 5F Select Catheter to access the desired anatomy. The sheath component of the device contains an inner diameter of 6 French (Fr) and lengths ranging from 55 - 115 centimeters (cm).

The provided text is a 510(k) summary for the Penumbra Element Vascular Access System. It describes the device, its intended use, and comparison to predicate devices, along with a summary of performance data. However, this document does not contain information about studies involving artificial intelligence (AI) or machine learning (ML) components.

The "Performance Data" section (1.11 and 1.11.1) outlines bench performance testing, which are standard engineering tests for medical devices (e.g., dimensional, tensile, particulate, leakage, fluoroscopy, friction, corrosion, elongation, stiffness, flexibility). There is no mention of an algorithm, AI, or ML being part of the device or its function.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance related to AI/ML.
• Sample sizes, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth types, or training set details for an AI/ML model, as no such model is described in this submission.

The "K242520" 510(k) is for a physical medical device (catheter introducer) and not for a software as a medical device (SaMD) or a device with an AI/ML component that requires the types of studies you are asking about (like diagnostic or image analysis AI).

If you have a different document that details an AI/ML component of this device, please provide that. Based solely on the provided text, the device itself is a conventional vascular access system.

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