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GT2 Fusion Guide Wires are steerable guide wires that are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion. The GT2 Fusion Guide Wires are not intended for use in the cerebral vasculature. GT2 Fusion steerable exchange wires are used to facilitate the substitution of one diagnostic or interventional device for another

The major components of the device include the hypotube, core wire, spring, and forming member. The Medtronic® GT2 Fusion Guide Wire is similar in performance to the predicate devices. These wires will be available in: .014" diameter 180cm & 300 cm in length Straight and "J" tip configurations PTFE coating with Pro/Pel coating and PTFE coating with hydrophilic coating on the distal 60 cm.

The provided text describes a 510(k) summary for the Medtronic® GT2 Fusion Guide Wire, a medical device for use in the coronary and peripheral vasculature. The information primarily focuses on the device's technical specifications and a comparison to predicate devices, rather than a clinical study evaluating its performance against specific acceptance criteria.

Therefore, many of the requested details, such as the use of experts, adjudication methods, multi-reader multi-case studies, and ground truth for training sets, are not applicable or not provided in this document as they are typically associated with performance evaluation of diagnostic or AI-driven devices. This document refers to in-vitro performance testing rather than clinical or AI-related studies.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified for the in-vitro performance testing. The document states "In-vitro performance testing of the guidewire included..." but does not give specific numbers of units tested for each criterion.
• Data Provenance: The tests were "in-vitro," meaning conducted in a laboratory setting, not on patient data. There is no mention of country of origin for any data or whether it was retrospective or prospective, as these terms are relevant for clinical or observational studies on patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not Applicable. This document describes engineering performance tests for a physical device, not a diagnostic or AI device requiring expert-established ground truth from, for example, medical images.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, typically for image-based diagnostic evaluations. This is not mentioned as part of the in-vitro performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is a type of clinical study used to evaluate the performance of diagnostic tests (often involving human readers and AI systems). This document focuses on the in-vitro physical and mechanical performance of a guide wire, not a diagnostic or AI device.

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

• No. This is not an AI algorithm. The tests are for a physical guide wire.

7. The Type of Ground Truth Used

• Engineering Specifications/Standards: The "ground truth" for the in-vitro tests would be the pre-defined engineering specifications and performance standards that the guide wire was designed to meet (e.g., a specific tensile strength value, acceptable range for tip whip). The report states, "Test results verified that the Medtronic® GT2 Fusion Guide Wires meet all of the applicable specifications."

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. See point 8.

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