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The Glidewire® GT 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 Glidewire® GT is a guide wire which is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. It is provided sterile and is intended for single use only. The Glidewire® GT consists of a core wire of a Nickel Titanium superelastic alloy and has a flexible radiopaque gold coil around the distal tip of the core wire. The Glidewire® GT is offered with two distal tip types: Shapeable and Preshaped. The wire distal segment comes in angled or straight configurations. Physicians choose the guide wire types depending upon their personal preference and the type of interventional procedure being performed. Other considerations may include: anatomy, difficulty of access, and the interventional device used for procedure. The device is packaged in a plastic holder that is contained within an individual package. A guide wire inserter, torque device and mandrel (Shapeable type only) are contained within the individual package to assist with the manipulation of the guide wire. Following the guide wire insertion, the guide wire inserter is removed from the proximal portion of guide wire.

The provided document is a 510(k) summary for the Glidewire GT and describes non-clinical performance and biocompatibility testing to demonstrate substantial equivalence to a predicate device. It does not contain information about a study proving the device meets an acceptance criterion for an AI/ML device.

Here's an analysis based on the structure of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several performance tests. It states that "All samples tested met the applicable acceptance criteria, and no new issues of safety and effectiveness were raised by the testing performed." However, it does not explicitly list the specific quantitative acceptance criteria alongside the reported performance for each test. Instead, it refers to ISO standards, FDA guidance documents, and in-house standards.

General Summary of Performance Testing:

Biocompatibility: The device is classified as Externally Communicating Devices, Circulating blood, Limited Contact (<24 hrs). It's deemed biocompatible based on substantial equivalence to predicate devices with the same classification, intended use, body contact, and contact duration, and demonstrated histories of safe and effective clinical use.

Sterilization: Validated in accordance with ISO 11135: 2014 to provide a Sterility Assurance Level (SAL) of 10-6.

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

The document states, "All samples tested met the applicable acceptance criteria," indicating that a test set was used for each performance test. However, the specific sample sizes for each test are not provided.

Data Provenance: The data comes from non-clinical (bench) performance testing and biocompatibility evaluation based on predicate devices. There is no mention of country of origin as it's not clinical data, nor is it retrospective or prospective in the sense of patient data.

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

This information is not applicable as the document describes a 510(k) submission for a medical device (guide wire) based on non-clinical performance and biocompatibility. It does not involve AI/ML, image analysis, or expert-established ground truth on a test set in the context of an AI/ML device. The "ground truth" for the performance tests would be the established scientific and engineering principles and standards against which the functional performance of the guide wire is measured.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert review of data/images to establish ground truth for AI/ML performance evaluation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not described in this document.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) performance study was not done. This document pertains to a physical medical device (a guide wire), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance and biocompatibility studies is derived from:

• Recognized consensus ISO standards (e.g., ISO 11070: 2014, ISO 11135: 2014, ISO 10993-1: 2009)
• FDA guidance documents (e.g., Coronary and Cerebrovascular Guidewire Guidance, Class II Special Controls Guidance Document for Certain PTCA Catheters)
• In-house standards of Terumo Medical Corporation
• Biocompatibility data and clinical histories of legally marketed predicate devices

8. The Sample Size for the Training Set

This information is not applicable as the document describes a physical medical device (guide wire) and not an AI/ML device that requires a training set.

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

This information is not applicable for the same reasons as #8.

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