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The Glidewire GT-R is intended 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 subject device, Glidewire GT-R, and the predicate device, Glidewire GT (K170417), are both operated through a manual process. The subject device, Glidewire GT-R, and the predicate device, Glidewire GT (K170417), are the same design and construction except for Guide wire length. The subject device, Glidewire GT-R, and the predicate device, Glidewire GT (K170417), are constructed from the same materials. The only material difference lies in the Individual Packaging.

This document is a 510(k) Pre-market Notification for a medical device called Glidewire GT-R. It focuses on demonstrating substantial equivalence to an existing predicate device rather than proving novel performance characteristics through a clinical trial or a deep-dive AI performance study.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving a device meets these criteria in the context of an AI/human-in-the-loop performance study.

Here's why and what the document does provide:

• Device Type: The Glidewire GT-R is a physical medical device (a catheter guide wire), not a software device or an AI algorithm.
• Purpose of 510(k): The 510(k) submission aims to show that the new device (Glidewire GT-R) is substantially equivalent to a legally marketed predicate device (Glidewire GT). This means it has the same intended use, similar technological characteristics, and performs as safely and effectively as the predicate.
• Testing Focus: The "performance testing" described (Section H, Table 3) is engineering performance testing (e.g., Tensile Strength, Torqueability, Lubricity, Kink Resistance, Radiopacity). These tests ensure the physical properties and functionality of the guidewire itself meet established physical and mechanical standards and are comparable to the predicate.
• No AI/Human Reader Study: Since this is a physical guidewire, there is no AI component, and thus no multi-reader multi-case (MRMC) study, human reader improvement, standalone algorithm performance, or ground truth establishment (expert consensus, pathology, outcomes data) as would be relevant for an AI diagnostic device.
• "Acceptance Criteria" in this context: The acceptance criteria here refer to the passing thresholds for the physical performance tests listed in Table 3 (e.g., a certain minimum tensile strength, a maximum friction coefficient for lubricity). The document states, "Performance testing met the predetermined acceptance criteria and is acceptable for clinical use throughout its shelf life." However, it does not provide the specific numerical acceptance criteria for each test or detailed results beyond this summary statement.

To directly answer your request based on the provided text, while noting the different context:

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

   • Acceptance Criteria: Not explicitly detailed as numerical values in the document. The document states "Performance testing met the predetermined acceptance criteria."
   • Reported Device Performance: The document provides a summary statement that the device met these criteria, but no specific quantitative results for each test item listed in Table 3.

   Test Item	Acceptance Criteria	Reported Device Performance
   Dimensional Verification	(Not specified, but assumed to be within manufacturing tolerances for guidewire dimensions.)	"met the predetermined acceptance criteria"
   Visual Inspection	(Not specified, e.g., no defects, smooth coating.)	"met the predetermined acceptance criteria"
   Simulated Use	(Not specified, e.g., successful navigation through a simulated vessel model without kinking or breaking.)	"met the predetermined acceptance criteria"
   Tensile Strength	(Not specified, but would be a minimum force required to break/yield.)	"met the predetermined acceptance criteria"
   Tip Pull	(Not specified, e.g., a minimum force to separate the tip.)	"met the predetermined acceptance criteria"
   Torque Strength	(Not specified, e.g., a minimum torque before a permanent twist.)	"met the predetermined acceptance criteria"
   Torqueability	(Not specified, e.g., the ability to transmit torque from the proximal to distal end smoothly.)	"met the predetermined acceptance criteria"
   Lubricity and Coating Integrity	(Not specified, e.g., a coefficient of friction, or visual assessment after use.)	"met the predetermined acceptance criteria"
   Particulate Evaluation	(Not specified, e.g., maximum number/size of particulates released.)	"met the predetermined acceptance criteria"
   Kink Resistance	(Not specified, e.g., ability to resist kinking at certain bend radii.)	"met the predetermined acceptance criteria"
   Tip Flexibility	(Not specified, e.g., ability to bend to a certain radius and return.)	"met the predetermined acceptance criteria"
   Radiopacity	(Not specified, e.g., visibility under fluoroscopy to a certain standard.)	"met the predetermined acceptance criteria"
   Shaping Test	(Not specified, for shapeable types, ability to hold a formed shape.)	"met the predetermined acceptance criteria"
   Shape Retention	(Not specified, for shapeable types, ability to retain shape after use.)	"met the predetermined acceptance criteria"
   Corrosion resistance	(Not specified, e.g., no signs of corrosion after exposure to specific solutions.)	"met the predetermined acceptance criteria"

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

   • The document does not specify the sample sizes (number of guidewires) used for each performance test.
   • Data Provenance: The tests were conducted internally by Terumo Corporation (Ashitaka Factory, Japan and Terumo Medical Corporation, NJ, USA) on their manufactured devices. The data is prospective, generated specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is a physical device, and the "ground truth" is determined by engineering measurements against pre-defined specifications, not by expert consensus on clinical images/data.

4. Adjudication method for the test set: Not applicable for engineering performance tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. This is not an AI or diagnostic imaging device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, not applicable.

7. The type of ground truth used: For the physical performance tests, the "ground truth" is based on engineering specifications and recognized industry standards (e.g., ISO, internal company standards). The predicate device and reference devices informed the establishment of these acceptance criteria.

8. The sample size for the training set: Not applicable, as this is a physical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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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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