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The Warrior 14 guidewire is intended for use in percutaneous procedures to introduce and position cathers and other interventional devices within the coronary and peripheral vasculature.

Device Description

The Warrior 14 guidewire is a 0.014" diameter stainless steel core guidewire with a 0.009" diameter tapered distal tip. The distal 20cm of the guidewire has a spring coil, of which the distal 2.5cm is visible under fluoroscopic methods. The guidewire has a straight shapeable tip with a tip load of 14 grams. The distal portion of the guidewire has a hydrophilic coating and the proximal portion has a PTFE coating. It is available in 190cm and 300cm lengths. The proximal end of the 190cm version has a guidewire extension feature. The Warrior 14 guidewire is intended for single use and sterilized with ethylene oxide.

AI/ML Overview

The provided document is a 510(k) summary for the Warrior 14 guidewire, a medical device. It does not describe an AI/ML device or a study comparing AI performance against acceptance criteria. Instead, it details the substantial equivalence determination process for a traditional medical device (a guidewire) based on biocompatibility and bench testing.

Therefore, the requested information about acceptance criteria for an AI device, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for AI is not applicable to this document. The document focuses on the physical and material properties of the guidewire and its comparison to a predicate device.

However, I can extract the acceptance criteria and performance data for the guidewire as presented in the document, which are primarily related to safety and performance through bench and biocompatibility testing.

Here's a summary of the relevant information provided in the document:

1. A table of acceptance criteria and the reported device performance

Test Category	Acceptance Criteria (Implied by testing)	Reported Device Performance
Biocompatibility	Device must be non-cytotoxic, non-sensitizing, non-irritating, non-systemically toxic, non-pyrogenic, non-hemolytic, not an activator of the complement system, and thromboresistant. (Based on ISO 10993-1)	Passing results from biomaterial tests demonstrate that the Warrior 14 guidewire is non-cytotoxic, non-sensitizing, non-irritating, non-systemically toxic, non-pyrogenic, non-hemolytic, not an activator of the complement system, and thromboresistant.
Performance - Bench	Device must meet specified criteria for catheter compatibility, coating adherence/integrity, corrosion resistance, dimensional analysis, radiopacity, tensile strength, tip flexibility, tip shapeability, torqueability, and torque strength, and not raise different questions of safety or effectiveness.	The results of the verification tests met the specified acceptance criteria and did not raise different questions of safety or effectiveness.
Substantial Equivalence	The device should not raise different questions of safety and effectiveness compared to the predicate device, and be substantially equivalent in technology, materials, and performance.	The technological differences do not raise different questions of safety and effectiveness. The Warrior 14 guidewire is identical to the predicate device in its indications for use and substantially equivalent in technology, materials, and performance.

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

This information is not provided in the document. The document refers to "biomaterial tests" and "verification tests" but does not specify the sample sizes (e.g., number of guidewires tested for each bench test) or data provenance. These are typically internal lab tests conducted by the manufacturer.

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 information is not applicable as the document describes a physical medical device (guidewire) and its bench/biocompatibility testing, not an AI device requiring expert ground truth for image or data interpretation.

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

This information is not applicable for the same reasons as point 3.

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 information is not applicable as the document describes a physical medical device (guidewire), not an AI-assisted diagnostic tool.

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

This information is not applicable as the document describes a physical medical device (guidewire), not an AI algorithm.

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

For the biocompatibility tests, the "ground truth" is established by the specified standards (ISO 10993-1) and the observed biological responses. For the bench performance tests, the "ground truth" is the established engineering specifications and measurement results. These do not involve expert consensus in the typical sense of diagnostic interpretation.

8. The sample size for the training set

This information is not applicable as the document describes the testing of a physical medical device (guidewire), not an AI/ML model that requires a training set.

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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