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Traxcess™ 7 Mini Guidewire is indicated for general intravascular use, including the neuro and peripheral vasculature. The guidewire can be steered to facilitate the selective placement of diagnostic catheters. This device is not indicated for use in coronary arteries.

Device Description

Traxcess™ 7 Mini Guidewire consists of a proximal coated 0.014" stainless steel core wire, and a distal coated 0.007" nitinol core wire. The distal core wire is tapered at the distal tip and is contained within platinum/nickel coil. The platinum/nickel coil is 6 cm in length. The distal 1.4 cm of the guidewire is shapeable by the physician. Traxcess™ 7 Mini Guidewire distal and proximal sections are coated with hydrophilic coating. There is no PTFE coating. The purpose of the hydrophilic coating is to provide lubricity when the MicroVention guidewire is passed through microcatheters. Shaping mandrels, insertion tool, and torque device are also included with the device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Traxcess™ 7 Mini Guidewire." This is a medical device submission seeking substantial equivalence to a previously cleared device, not an AI/ML powered device. As such, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" are discussed in terms of traditional medical device performance testing, rather than clinical studies involving AI performance metrics like sensitivity, specificity, or reader studies.

Here's a breakdown of the requested information based on the provided text, adapted for a non-AI medical device:

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

Acceptance Criteria (Performance Requirement)	Reported Device Performance
Physical attributes: Met specified dimensional requirements for guidewire OD, overall length, length of Pt/Ni coil section, length of SS section, length of PTFE coated section, length of hydrophilic coated section, length of proximal docking section and accessory devices.	Device met established dimensional specifications.
Surface Contamination: Test article, when examined at magnification, should meet existing surface contamination and defects specification.	Device was free from surface defects and contamination.
Corrosion Resistance: Test article should be corrosion resistant.	Device met established corrosion resistance.
Guidewire Coating adherence: Coating adherence maintained after advance/retract cycles.	Durability and lubricity of coating was maintained after advance/retract cycles.
Guidewire fracture resistance: Test article should not show signs of fracture. There should be no coating flaking off the guidewire.	Device met established fracture resistance specification.
Guidewire tip shapeability: Test article should be greater than or equal to existing tip shapeability specification.	Device met established Guidewire tip shapeability specification.
Torque Strength: Test article should be greater than or equal to existing torque strength specification.	Device met established torque strength specification.
Torque Response: Test article should be equivalent to, or better than predicate device.	Subject device torque response equivalent to predicate device.
Flexing test: Test article should not show signs of defect, fracture or other damage. There should be no coating flaking off the guidewire.	Device met established flexing test specification.
Distal tip flexibility: Test article should be less than existing distal tip specification to deflect the distal tip of guidewire.	Device met established distal tip flexibility specification.
Tensile strength: Test article should be greater than or equal to existing tensile strength specification for distal tip and proximal joint section.	Device met established distal tip and proximal joint tensile strength specification.
Simulated use testing: Test articles achieved rating ≥ 3 for prep of device, introduction, and tracking.	Device performed as intended under simulated use.
Particulate Testing: Particle count of test articles ≤ 25 particles (≥ 10 microns) and ≤ 3 particles (≥ 25 microns).	Device has comparable particulate results to the predicate device.

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

The document does not explicitly state the sample sizes used for each specific bench test (e.g., number of guidewires tested for tensile strength). The data provenance is described as "Bench Testing," meaning these are laboratory-generated results on physical samples of the device, not patient data. Therefore, concepts like "country of origin of the data," "retrospective or prospective" do not apply in the context of this submission.

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 question is not applicable to this type of device submission. The "ground truth" for these physical performance tests are objective engineering specifications and measurements, not expert interpretations of clinical data. For example, a guidewire's diameter is measured with instruments, not subject to expert consensus.

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

This question is not applicable as the tests are objective physical measurements and not subject to human adjudication of clinical findings.

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 question is not applicable. The device is a physical guidewire, not an AI-powered diagnostic or assistive tool that would involve human readers or affect their performance.

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

This question is not applicable, as the device is a physical guidewire, not an algorithm.

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

For the bench testing, the "ground truth" is defined by established engineering and device specifications (e.g., dimensional requirements, material properties, mechanical performance criteria). For the biocompatibility aspect, the ground truth for the reference device (Traxcess™ 14 SELECT Guidewire) would have been established through a series of biocompatibility tests according to ISO standards, which evaluate the biological response to the device material.

8. The sample size for the training set

This question is not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This question is not applicable as there is no training set for this physical device.

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