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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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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 0.014 inches and lengths of 180 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.

This document describes the Roadrunner® Extra Support Wire Guide (K171948) and its substantial equivalence to a predicate device. The information provided outlines several tests performed to demonstrate the device meets acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not explicitly state the specific sample sizes used for each test. The provenance of the data is retrospective, as the tests were performed on the device after manufacturing to demonstrate conformance to standards. The country of origin of the data is not specified, but the manufacturing company (Cook Incorporated) is based in Bloomington, Indiana, USA, suggesting the testing was likely conducted in the US or by US-affiliated entities.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is a medical device (guidewire) submission, not an AI/software submission. Therefore, the concept of "experts" establishing a "ground truth" for the test set in the context of medical imaging or diagnostic algorithms does not apply. The ground truth for device performance is established through adherence to recognized international and FDA standards, and engineering specifications.

4. Adjudication method for the test set
Not applicable. This is a medical device submission, not an AI/software submission that would involve adjudication of interpretations. Device performance is determined by meeting pre-defined quantitative and qualitative engineering and material science criteria.

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
Not applicable. This is a medical device submission; no AI component or human reader study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device submission; no standalone algorithm performance is discussed.

7. The type of ground truth used
The "ground truth" for this medical device is the adherence to established international and FDA performance standards and the stated engineering specifications. These standards (e.g., BS EN ISO 11070, ASTM F640, FDA Guidances) define the acceptable limits and characteristics for the device's physical and mechanical properties.

8. The sample size for the training set
Not applicable. This is a medical device submission, not an AI/software submission. There is no concept of a "training set" in the context of mechanical device testing for substantial equivalence.

9. How the ground truth for the training set was established
Not applicable. See point 8.

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