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The 0.014" Willow Guidewire is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Device Description

Like the predicate device, the 0.014" Willow Guidewire is a single-use product with a shapeable tip available in straight and pre-shaped configurations, used to gain intravascular access to facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro and peripheral diagnostic and interventional procedures. The wire can be torqued to facilitate navigation through the vasculature. The 0.014" Willow Guidewire comes in three stiffness profiles: Soft, Standard and Support.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the 0.014" Willow Guidewire do not describe a study involving an AI/Machine Learning device.

Instead, this document describes a traditional medical device (a guidewire) and its clearance process through substantial equivalence to a legally marketed predicate device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biocompatibility bench testing, not clinical performance studies for an AI algorithm.

Therefore, many of the questions related to AI/ML device performance (like sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, effect size of AI assistance) are not applicable to this document.

However, I can extract the relevant information regarding the acceptance criteria and the engineering study (bench performance testing) for the 0.014" Willow Guidewire.

Acceptance Criteria and Study for the 0.014" Willow Guidewire

The 0.014" Willow Guidewire is a traditional medical device, not an AI/ML device. Therefore, the "acceptance criteria" and "study" refer to engineering specifications and bench performance testing, along with biocompatibility testing, to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by "Acceptance criteria were met" or "considered acceptable" for each test. The reported device performance is that these criteria were successfully achieved.

Test	Test Method Summary	Reported Device Performance / Conclusions
Bench Performance Testing
Coating Lubricity	Hydrophilic coating lubricity was assessed after multiple pull cycles through silicone pads.	Acceptance criteria were met.
Coating Durability	Coating durability was assessed after repeating multiple pull cycles through silicone pads.	Acceptance criteria were met.
Coating Integrity	Per FDA guidance "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019). Inspected pre- and post-simulated use tracking with comparison to predicate.	Coating integrity was reported and considered acceptable.
Corrosion Resistance	Per FDA guidance "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019).	Acceptance criteria were met.
Dimensional & Visual Insp.	Per FDA guidance "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019). Verified key dimensions.	Acceptance criteria were met.
Flex Fatigue	Subjected guidewire to multiple flexure cycles around cylindrical pins.	Acceptance criteria were met.
Fracture	Subjected guidewire to multiple wrappings around cylinder and visually inspected for signs of fracture.	Acceptance criteria were met.
Kink Resistance	Per FDA guidance "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019). Wrapped guidewire around test fixture with clinically relevant radii.	Acceptance criteria were met.
Particulate Characterization	Per FDA guidance "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019). Counted particulates after tracking through tortuous simulated use model, with comparison to predicate.	Particulate counts were reported and considered acceptable.
Radiopacity	Per FDA guidance "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019). Evaluated subject and predicate guidewires under fluoroscopy.	All Willow Guidewires demonstrated acceptable radiopacity; comparable to predicate.
Simulated Use	Per FDA guidance "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019). Tested with microcatheter, introducer, and torque device while navigating to target in a tortuous simulated use model.	Acceptance criteria were met.
Tensile Strength	Per FDA guidance "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019). Measured force to break at each bond.	Acceptance criteria were met.
Tip Flexibility	Per FDA guidance "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019). Measured force to deflect tip at 5 mm, 10 mm, and 20 mm gauge lengths, compared to predicate.	Acceptance criteria were met.
Tip Shapeability	Shaped the guidewire tip three times per labeling.	Acceptance criteria were met.
Tip Shape Retention	Measured tip shape retention after tracking through a tortuous simulated use model.	Acceptance criteria were met.
Torqueability	Per FDA guidance "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019). Tracked through tortuous simulated use model; evaluated steerability and torque response.	Acceptance criteria were met.
Torque Strength	Per FDA guidance "Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling" (2019). Recorded rotations until failure.	Acceptance criteria were met.
Biocompatibility Testing
Acute Systemic Toxicity	Per ISO 10993-11.	Pass: No evidence of acute systemic toxicity.
Compliment Activation	Per ISO 10993-4.	Pass: Non-activator.
Cytotoxicity – MEM Elution	Per ISO 10993-5.	Pass: Non-cytotoxic.
Hemolysis	Per ISO 10993-4.	Pass: Non-hemolytic.
Intracutaneous Reactivity	Per ISO 10993-10.	Pass: Non-reactive.
In Vivo Thrombogenicity	Per ISO 10993-4.	Pass: Non-Thrombogenic.
Pyrogenicity	Per ISO 10993-11.	Pass: Non-pyrogenic.
Sensitization	Per ISO 10993-10.	Pass: Non-sensitizing.

Information Not Applicable (NA) to this Device/Submission:

The following questions are specifically targeted at AI/ML medical devices and are not relevant to the 0.014" Willow Guidewire, which is a traditional physical medical device.

Sample size used for the test set and the data provenance: NA (This is a physical device, not an AI/ML algorithm requiring a data test set.)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: NA (No "ground truth" in the AI/ML sense is established for this type of device.)
Adjudication method (e.g. 2+1, 3+1, none) for the test set: NA (No adjudication method described for physical device testing.)
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: NA (No MRMC study or AI assistance involved.)
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: NA (Not an algorithm.)
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): NA (Ground truth is not a concept applied in this context; performance is measured against engineering specifications and predicate characteristics.)
The sample size for the training set: NA (No training set for a physical device.)
How the ground truth for the training set was established: NA (No training set or ground truth in this context.)

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