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For use in facilitating delivery of percutaneous catheters into the peripheral vasculature.

The Roadrunner® UniGlide™ Hydrophilic Wire Guide is a hydrophilically coated device constructed of a nitinol core wire with a polyurethane jacket. It is available in diameters ranging from 0.018 in. to 0.038 in. and lengths from 80 cm to 320 cm. The Roadrunner® UniGlide Hydrophilic Wire Guide is manufactured in both a standard shaft and a stiff shaft version. A torque device is supplied with the Roadrunner® UniGlide™ Hydrophilic Wire Guide. The torque device is designed for torque control and is intended for use in complex diagnostic and interventional procedures.

This submission details a 510(k) premarket notification for a modified medical device, the Roadrunner® UniGlide™ Hydrophilic Wire Guide. Since this is a premarket notification for a modified device seeking substantial equivalence to a predicate device, the acceptance criteria and study focus on demonstrating that the modifications do not alter the safety and effectiveness of the device compared to the previously cleared predicate.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not specify the sample size used for the "Hydrated Lubricity Test." It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). Given that the testing was performed to demonstrate substantial equivalence for a manufactured device, it's highly likely this was a prospective test conducted by the manufacturer, Cook Incorporated, in the USA.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of submission for a physical medical device (a guide wire) does not involve "experts" establishing ground truth in the sense of medical diagnosis or image interpretation. The ground truth for device performance is based on direct physical testing against engineering specifications and comparisons to the predicate device's established performance. Therefore, this question is not applicable in the context of this document.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are common in studies involving subjective assessments, such as image interpretation, where disagreements between experts need to be resolved. For objective physical device testing like lubricity, an adjudication method is not applicable. The results are typically numerical measurements compared against predefined thresholds or the predicate's performance.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study is used to evaluate the impact of a diagnostic tool or AI on human readers' performance (e.g., radiologists interpreting images). This submission is for a physical medical device (a guide wire) and does not involve human readers interpreting data in this context. Therefore, this question is not applicable.

6. Standalone Performance Study

Yes, in a sense. The "Hydrated Lubricity Test" represents a standalone performance evaluation of the modified device itself against a specific physical property (lubricity). While the primary purpose was to demonstrate equivalence to the predicate, the test assesses the device's intrinsic performance attribute. The performance is reported as "equivalent" rather than absolute values.

7. Type of Ground Truth Used

The ground truth used is based on engineering specifications and comparative performance data derived from the predicate device. For the "Hydrated Lubricity Test," the ground truth for "equivalent" performance is the established hydrated lubricity of the predicate device (K110009). The new lengths of the device must meet or perform similarly to this established benchmark.

8. Sample Size for the Training Set

This submission does not involve a "training set" in the context of machine learning or AI models. This is a physical medical device with a modification, and its performance is evaluated through physical and functional testing, not through training data for an algorithm. Therefore, this question is not applicable.

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

As stated above, there is no "training set" in this context. Therefore, this question is not applicable. The ground truth for the performance evaluation (lubricity) was established by the predicate device's known performance.

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