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Traxcess .007" 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.

Traxcess .007" Mini Guidewire is a coiled wire that is designed to fit inside a percutaneous microcatheter for the purpose of directing the catheter through a blood vessel. It consists of a proximal coated Stainless Steel core wire, and a distal coated Nitinol core wire. The distal core wire is tapered at the distal tip and is contained within a 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 .007" Mini Guidewire distal and proximal sections are coated with hydrophilic coating. The purpose of the hydrophilic coating is to provide lubricity when the MicroVention guidewire is passed through microcatheters. A shaping mandrel, insertion tool, and torque device are also included with the device

The provided document pertains to the 510(k) summary for the Traxcess .007" Mini Guidewire (K161803), which is a medical device. This document describes that the subject device is substantially equivalent to a predicate device, the Traxcess® 14 SELECT Guidewire (K153053). The core of the submission relies on demonstrating this substantial equivalence through various tests.

Here's an analysis of the acceptance criteria and the studies performed, based on the provided text, using the specified categories:

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

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

• Sample Sizes: The document does not explicitly state numerical sample sizes for most of the bench tests. It generally refers to "test article" or "test samples." For some tests, there are references to "number of turns to guidewire failure" or "animal study" but without specific numbers of devices or animals.
  • Animal Testing: The document mentions "animal study" for trackability, friction and handling, radiopacity, compatibility, and overall assessment. For Biocompatibility, "at least 10% of the test animals" is mentioned for sensitization/irritation, "New Zealand White rabbits" for intracutaneous injection, "albino mice" for systemic injection, and "rabbit" for pyrogen test. Crucially, animal testing for performance was comparative with the predicate device, but specific numbers were not provided. "Dog Thrombogenicity" is mentioned.
• Data Provenance: The document does not specify the country of origin. The submission is from MicroVention, Inc. in Tustin, California, USA, implying the studies were likely conducted in the USA or by labs commissioned by them. The studies are prospective in the sense that they were conducted for this 510(k) submission to demonstrate equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable to this document. The submission is for a catheter guidewire, which relies on objective physical, chemical, and biological performance criteria, rather than subjective interpretation by human experts. The "ground truth" here is objective measurement against engineering specifications and biological safety standards, not expert consensus on qualitative data like medical images.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation, often with multiple readers, to resolve discrepancies. The tests described are objective, and the results are directly measured against predetermined criteria.

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 section is not applicable. This document is for a physical medical device (guidewire) and does not involve AI or human "readers" or subjective interpretation of cases. Therefore, an MRMC study related to AI assistance is not relevant.

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

This section is not applicable. As mentioned above, this is for a physical medical device and does not involve algorithms or AI.

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

The "ground truth" for the tests performed is primarily based on:

• Engineering Specifications: Predetermined dimensional requirements, tensile strength, torque strength, shapeability specifications, etc., set for the device's physical performance.
• Biological Safety Standards: Benchmarks derived from ISO standards (e.g., ISO 10993 series) for biocompatibility, such as acceptable levels of cytotoxicity, sensitization, hemolysis, pyrogenicity, etc.
• Comparative Performance: For some tests (e.g., torqueability, animal study trackability), the predicate device served as a direct comparison, where the subject device had to be "equal to or better than" the predicate.

8. The sample size for the training set

This section is not applicable. The device does not involve machine learning or AI, and therefore does not have a "training set" in that context. The "training" here would refer to the design and manufacturing process iteration, which is not quantified as a "sample size" in this context.

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

This section is not applicable for the same reason as point 8.

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