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The Mandril Wire Guide, subject of this submission, is a Class II device according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The subject device consists of a stainless steel or nitinol mandril design with a stainless steel, palladium, or platinum distal spring coil anchored over the distal portion of the mandril. The Mandril Wire Guide is available with outside diameters ranging from 0.015 inches to 0.018 inches and lengths ranging from 25 centimeters (cm) to 180 cm. The tip portion of the subject device is either straight or angled. The Mandril Wire Guide is a packaged, sterile device intended for single patient use.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Cook Incorporated Mandril Wire Guide (K171997). The document outlines the device description, intended use, comparison to a predicate device, and the technological characteristics demonstrated through various tests.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria (Stated)	Reported Device Performance
Biocompatibility Testing	Pre-determined acceptance criteria were met	The pre-determined acceptance criteria were met.
Corrosion Testing	Pre-determined acceptance criteria were met	The pre-determined acceptance criteria were met.
Flexing Test	Pre-determined acceptance criteria were met	The pre-determined acceptance criteria were met.
Fracture Testing	Pre-determined acceptance criteria were met	The pre-determined acceptance criteria were met.
Tensile Testing	Pre-determined acceptance criteria were met	The pre-determined acceptance criteria were met.
Tip Flexibility Testing (Tip Deflection)	Pre-determined acceptance criteria were met	The pre-determined acceptance criteria were met.
Torqueability Testing (Rotational Response)	Pre-determined acceptance criteria were met	The pre-determined acceptance criteria were met.
Torque Strength Testing	Pre-determined acceptance criteria were met	The pre-determined acceptance criteria were met.
Radiopacity Testing	Pre-determined acceptance criteria were met	The pre-determined acceptance criteria were met.
Surface Examination	Pre-determined acceptance criteria were met	The pre-determined acceptance criteria were met.
Dimensional Measurement Testing	Pre-determined acceptance criteria were met	The pre-determined acceptance criteria were met.
Catheter Compatibility Testing	(Not explicitly stated as "met," but implied)	Performed in accordance with FDA guidance.
Acute Performance Evaluation (Animal Model)	Pre-determined acceptance criteria for all performance parameters were met	All test articles evaluated met the predetermined acceptance criteria for all of the performance parameters.

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

The document does not provide specific sample sizes for any of the individual tests. It states that "All test articles evaluated" for the Acute Performance Evaluation met the criteria, implying all samples used in that test.

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective for most tests. However, the Acute Performance Evaluation was conducted in an animal model, which is a prospective study design to simulate clinical use.

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

This information is not provided in the document. The tests described are primarily engineering and performance tests on the device itself, not assessments requiring human expert interpretation for "ground truth" in the way a diagnostic AI might.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The tests described are objective measurements of the device's physical properties and performance against pre-defined criteria, not subjective assessments requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically for diagnostic devices that involve human interpretation of images or data, often comparing AI-assisted performance to unassisted human performance. The Mandril Wire Guide is a physical medical device (guidewire), and its evaluation focuses on its mechanical, material, and functional properties.

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

This question is not applicable. The Mandril Wire Guide is a physical medical device, not an algorithm or software that operates in a standalone manner. Its performance is inherent to its physical design and construction.

7. The Type of Ground Truth Used

For the various engineering and performance tests (biocompatibility, corrosion, flexing, fracture, tensile, tip flexibility, torqueability, torque strength, radiopacity, surface examination, dimensional measurement, catheter compatibility), the "ground truth" is defined by established engineering and medical device standards (e.g., ISO, ASTM) and FDA guidance documents, along with an "approved study protocol" for dimensional measurements. These standards and protocols define the expected performance characteristics.

For the Acute Performance Evaluation, the ground truth is based on the device's performance in an animal model under simulated clinical conditions, against pre-determined acceptance criteria for various performance parameters. This is effectively an in-vivo performance assessment.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. A "training set" refers to data used to train machine learning algorithms. The Mandril Wire Guide is a physical device, and its development and testing do not involve machine learning training sets.

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

This information is not applicable for the same reasons as point 8.

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