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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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R2PTM Destination Slender™ Guiding Sheath is indicated to be used for the introduction of interventional and diagnostic devices in the lower extremities of the peripheral vasculature through an access site, including tut not limited to the radial artery.

The R2PTM 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 119cm and 149cm. It comes packaged with a dilator and hemostatic valve.

The provided FDA 510(k) summary for the Terumo R2P™ Destination Slender™ Guiding Sheath describes non-clinical performance testing to demonstrate substantial equivalence to predicate devices. It does not include clinical study data or information about AI/ML algorithms. Therefore, many of the requested categories related to clinical studies, expert-derived ground truth, and AI performance metrics cannot be populated from the provided text.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance

The document states that the R2P™ Destination Slender™ Guiding Sheath "met the predetermined acceptance criteria and results support a determination of substantial equivalence." However, the specific quantitative acceptance criteria for each test item are not explicitly listed in the provided tables, only the test items themselves and the reference standards used.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the document.
• Data Provenance: The document describes "non-clinical tests" and "performance testing" conducted. This refers to laboratory testing of the physical device, not patient data. Therefore, questions of country of origin or retrospective/prospective do not apply in the typical sense for clinical data. The manufacturer is Terumo Medical Corporation, located in the USA (Somerset, NJ and Elkton, MD).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The testing described is non-clinical performance and biocompatibility testing of a physical medical device. "Ground truth" in the context of expert review for diagnostic AI software is not relevant here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of clinical data, which is not part of this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. This submission is for a physical medical device (guiding sheath), not AI software, and no clinical studies, especially MRMC, were conducted or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. This device is not an algorithm or AI software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This question is not applicable in the context of clinical "ground truth." For the non-clinical performance tests, the "ground truth" would be established engineering specifications, industry standards (ISO), and in-house standards against which the device's physical properties are measured.

8. The sample size for the training set

This question is not applicable. This device does not involve a "training set" as it is a physical medical device, not an AI/ML algorithm.

9. How the ground truth for the training set was established

This question is not applicable. As explained above, there is no "training set" for this device.

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