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The Radifocus Glidewire Advantage Track is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary interventions.

The Radifocus Glidewire Advantage Track is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures.

The Radifocus Glidewire Advantage Track consists of a Nickel Titanium alloy and stainless steel core wire. The distal portion from the junction is NiTi and the proximal portion is stainless steel. A polyurethane and hydrophilic coating is applied to the distal portion of the wire while a PTFE coating is applied to the proximal portion. The wire distal segment comes in angled configuration. The wire contains a distal radiopaque gold coil. The wire comes packaged in a plastic holder contained within an individual package. A guide wire inserter is contained within the individual package to assist with the insertion of the wire into a needle or catheter.

During an interventional or diagnostic procedure, the physician will follow the standard procedure of placing an access wire and introducer within a vessel. Once the introducer is placed, the physician may choose a wire such as the Radifocus Glidewire Advantage Track to gain access to the target lesion or therapeutic site. It is also used in conjunction with a catheter which is advanced over the wire to the desired anatomical location.

The provided document is a 510(k) Premarket Notification for a medical device, specifically the Radifocus Glidewire Advantage Track. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and biocompatibility testing. It does not describe an AI/ML-driven device or a study involving human readers or expert consensus for ground truth establishment. Therefore, most of the requested information regarding AI acceptance criteria and study methodology (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, ground truth types) is not applicable or cannot be extracted from this document.

Here's an analysis based on the information that is present in the document:

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

The document broadly states that "All testing met acceptance criteria" and "The Radifocus Glidewire Advantage Track met the predetermined acceptance criteria" for performance testing. However, the exact acceptance criteria values themselves are not explicitly detailed in a table; rather, it lists the standards against which the tests were conducted (e.g., ISO 11070:2014, FDA Guidance, In-house Standard). For biocompatibility, it states "Results of the testing demonstrate that the device is biocompatible throughout the shelf life of the product."

Table of Acceptance Criteria and Reported Device Performance (as inferred):

2. Sample sized used for the test set and the data provenance:

• Sample Size for Test Set: Not specified in the document. This is a non-clinical submission, and specific sample sizes for each mechanical/biocompatibility test are typically found in detailed test reports, not the 510(k) summary itself.
• Data Provenance: The tests are conducted by the manufacturer, Terumo Medical Corporation (Ashitaka Factory in Japan). The data is generated prospectively through laboratory testing.

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

• Not applicable. This device is a physical medical device (guidewire), not an AI/ML diagnostic tool requiring human expert interpretation or ground truth establishment in the diagnostic sense.

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

• Not applicable, as this is not an AI/ML diagnostic device with human interpretation.

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:

• No. This is not an AI/ML device, and no MRMC study was performed or is relevant to this submission.

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

• Not applicable. This is not an algorithm. Performance tests mentioned are for the physical guidewire itself.

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

• For this device, "ground truth" equates to the established standards and specifications for medical guidewires (e.g., ISO 11070:2014, in-house standards for physical properties, ISO 10993 for biocompatibility). Test results are compared against these predetermined specifications. There is no diagnostic ground truth (like pathology or expert consensus) involved.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/ML algorithm that requires a "training set."

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

• Not applicable. No training set is involved.

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