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The Roadrunner® Extra Support Wire Guide is intended for use in facilitating delivery of percutaneous catheters into the cardiovascular system.

The Roadrunner® Extra Support Wire Guide is manufactured in an outer diameter of 0.018 inch and lengths of 180, 270, and 300 centimeters. The flexible tip portion of the subject device is formed into an angled configuration. The Roadrunner® Extra Support Wire Guide consists of a coated mandril with a coil covering the tip of the mandril. A pin vise is supplied with the subject device.

The Roadrunner® Extra Support Wire Guide is a packaged, sterile device intended for single use.

The provided text is a 510(k) Premarket Notification from the FDA regarding the Roadrunner® Extra Support Wire Guide. It details the device's technical specifications and the testing performed to demonstrate its substantial equivalence to a predicate device.

Crucially, this document describes a traditional medical device (a guide wire), not an AI-powered diagnostic or therapeutic device. Therefore, many of the requested elements pertaining to AI-specific testing, such as expert consensus, ground truth establishment for training/test sets, MRMC studies, or standalone algorithm performance, are not applicable to this type of device submission. The study described focuses on the physical and material properties of the guide wire.

Below is an attempt to address the applicable points based on the provided text, while noting the limitations due to the nature of the device:

Device: Roadrunner® Extra Support Wire Guide

Study Purpose: To demonstrate substantial equivalence to a predicate device (Roadrunner® Extra Support Wire Guide, K171948) through performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each test. It generally states that "The following tests were performed to demonstrate..."

• Data Provenance: The tests were performed by the manufacturer, Cook Incorporated, located in Bloomington, Indiana, USA. The data is retrospective in the sense that it was collected as part of the device's design and verification process before submission for market clearance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

• Not Applicable. As this is a physical medical device, the "ground truth" for these tests relates to engineering specifications and material properties, established by the testing standards (e.g., BS EN ISO 11070:2014, ASTM F640-12, FDA Guidance). Human expert interpretation in the sense of clinical image reading or diagnosis is not involved in these particular tests. The tests are designed to objectively measure physical characteristics.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1 or 3+1) are common in clinical studies where human interpretation of data (e.g., radiology images) is subjective and requires consensus. For the physical and material tests performed on this guide wire, the acceptance criteria are objective and quantitative (e.g., "no signs of corrosion," "pre-determined acceptance criteria were met"). The results of these tests speak for themselves against predefined engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is relevant for AI systems that directly impact human reader performance (e.g., an AI assisting radiologists). This device is a physical wire guide, not an AI.

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

• Not Applicable. This is a physical device, not an algorithm. The tests performed are "standalone" in the sense that they evaluate the device's inherent properties, but not as an AI algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on established engineering standards and regulatory guidance documents (e.g., BS EN ISO 11070:2014, ASTM F640-12, FDA Coronary and Cerebrovascular Guidewire Guidance (1995)). These standards define the acceptable physical, mechanical, and material properties for such devices to ensure safety and effectiveness.

8. The Sample Size for the Training Set

• Not Applicable. This is a physical medical device. There is no concept of a "training set" in the context of developing an AI model, as the device itself is not an AI.

9. How the Ground Truth for the Training Set was Established

• Not Applicable. (See point 8).

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