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Cordis catheters are indicated for enabling diagnosis of various pathologies by facilitating of diagnostic devices within the coronary and peripheral vasculature.

The INFINITI Ambi Catheter is a 0.038" guidewire compatible catheter with a 3-staged braided nylon construction. The body is a braided nylon intended for torque responsiveness and stability. The proximal segment is a non-braided nylon for flexibility and shape retention. The Distal Tip is a soft, radiopaque nylon for minimal vessel cannulation. The INFINITI Ambi product line comes in 5F and 6F size and various curve style configurations. The device is a disposable intended for single use only. It is individually packaged and sterilized by ethylene oxide gas.

This document is a 510(k) Premarket Notification from the FDA regarding a medical device called the "INFINITI™ Ambi Angiographic Catheter." It is not a study proving the device meets acceptance criteria for an AI/ML medical device.

The document states that the device is a catheter and its purpose is for "enabling diagnosis of various pathologies by facilitating the positioning of diagnostic devices within the coronary and peripheral vasculature." It is a physical medical device, not a software device or an AI/ML algorithm.

Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, ground truth establishment, sample sizes for training/test sets, expert adjudication methods, and MRMC studies are not applicable to this document. This submission is for demonstrating "substantial equivalence" of a physical medical device to a predicate device, based on bench testing and biocompatibility testing, not AI/ML performance metrics.

The document explicitly states:

• "No clinical data was required in support of the proposed change to the predicate device cleared under K970854." (Page 9, Section VII. CLINICAL PERFORMANCE)
• The performance data section details Biocompatibility Testing, Sterilization, Packaging, and Bench Testing, which are standard for physical medical devices. (Page 7-8, Section VII. PERFORMANCE DATA)

Since the prompt asks for information about AI/ML device performance and this document concerns a traditional physical medical device, I cannot extract the requested information from the provided text.

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