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R2P™ Destination Slender™ Guiding Sheath is indicated for the introduction of interventional and diagnostic devices into the human vasculature through an access site, including but not limited to the radial artery.

The R2P™ Destination Slender™ Guiding Sheath is a low profile guiding sheath designed to perform as a guiding catheter and an introducer sheath. The sheath is coil reinforced, has a radiopaque tip, is hydrophilically coated, and is available in 6Fr with a length of 75cm, 85cm, 95cm, 105cm, 119cm and 149cm. It comes packaged with a dilator and hemostatic valve.

This document is a 510(k) Premarket Notification for a medical device called the "R2P™ Destination Slender™ Guiding Sheath." It is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study proving the device meets specific acceptance criteria in the context of an AI/ML-based medical device.

Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, expert involvement, ground truth establishment, MRMC studies, and standalone performance for an AI/ML device cannot be extracted from this document because this document is about a physical medical device (guiding sheath) and does not involve AI/ML technology or related performance studies.

The document primarily focuses on:

• Device Description: A guiding sheath used for introducing other medical devices into the human vasculature.
• Comparison to Predicate Device: Demonstrating that the new device is substantially equivalent to a previously cleared predicate device (K171491 R2P™ Destination Slender™ Guiding Sheath). This equivalence is based on intended use, technology/principle of operation, materials, and performance.
• Non-Clinical Testing: Performance tests (e.g., Ovalization, Simulated Use and Particulate, Coating Integrity, Torque Strength) conducted to ensure the device meets applicable design and performance requirements and supports substantial equivalence.
• Biocompatibility and Sterilization: Addressing these aspects based on previous testing of the predicate device, as the new device is essentially the same in composition and manufacturing, with only variations in length.
• Absence of Clinical Tests: Explicitly stating that this 510(k) does not include data from clinical tests.

To answer your prompt about acceptance criteria and study data for an AI/ML device, a different type of FDA submission (e.g., a De Novo request or a 510(k) for an AI/ML device) would be required, which would contain performance data derived from clinical or scientific studies involving algorithms and data sets.

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