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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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ASAHI Peripheral Vascular Guide Wire is intended for use in the peripheral vasculature, to facilitate the exchange and placement of diagnostic and therapeutic devices such as vascular catheters during peripheral interventional procedures. This guide wire is not intended for use in coronary arteries, lower limb blood vessels, neurovasculature and carotid arteries.

The ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 consists of a core wire and a coil assembly. The coil assembly consists of an inner coil and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16. The coil and taper core wire of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 are coated with polyurethane and coated with a hydrophilic polymer upon the polyurethane coat. The distal portion of ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 is soft in order to easily bend in accordance with the vessel curve. The ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16 is available in various lengths and tip shapes. Accessories such as a Torque device, Shaping device and Inserter are included in the packaging of the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16.

This document is a 510(k) Summary for the ASAHI® Peripheral Vascular Guide Wire ASAHI Meister® 16, submitted by ASAHI INTECC CO., LTD. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a dedicated study for a new clinical indication.

Therefore, many of the requested categories regarding acceptance criteria and study design for a new device or algorithm are not directly applicable or available in this document. This document describes the testing performed to show the new device is as safe and effective as a previously cleared device.

Here's the information extracted and organized as requested, with notes where information is not applicable or present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that non-clinical laboratory testing was performed and that the device "met all acceptance criteria." However, it does not explicitly list the specific quantitative acceptance criteria for each test. Instead, it generally states that the device "performed similarly to the predicate devices" and "functions as intended."

2. Sample size used for the test set and the data provenance

The document mentions "non clinical laboratory testing" and "in vitro bench tests." These are likely physical tests on device samples. The sample size for these tests is not specified in the provided text. The data provenance is laboratory testing (bench tests). There is no mention of patient data (country of origin, retrospective/prospective) as this is a physical device equivalence submission, not a clinical study of an AI/software device.

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

This information is not applicable to this type of device submission. Ground truth for physical device performance is typically established through standardized testing methods, not expert human assessment in the way it's used for AI diagnostic tools.

4. Adjudication method for the test set

This information is not applicable as there are no expert readers or interpretations for physical bench testing outcomes.

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 information is not applicable. This document describes a physical medical device (guide wire), not an AI algorithm, and therefore, an MRMC study or AI assistance is irrelevant.

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

This information is not applicable as this is a physical medical device, not an algorithm.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" would be established by objective measurements and predefined pass/fail criteria based on engineering specifications and comparison to the predicate device's established performance, rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable as this document does not describe an AI/ML algorithm that requires a training set.

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

This information is not applicable as this document does not describe an AI/ML algorithm that requires a training set.

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The Direxion and Direxion HI-FLO Torqueable Microcatheters are intended for peripheral vascular use. The pre-loaded Fathom and Transend Guidewires can be used to selectively introduce and position the microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.

The Direxion Microcatheter is available in small and large lumens. The Direxion Torqueable Microcatheter (Direxion) is a small lumen microcatheter with a distal outside diameter of 2.5F (0.85 mm), and a maximum outside diameter of 2.7F (0.95 mm). It has an inside diameter of 0.021 in (0.5 mm) minimally in the proximal and distal regions. The microcatheter lumen is able to accommodate steerable guidewires with diameters ≤ 0.018 in (0.47 mm).

The Direxion HI-FLO Torqueable Microcatheter (Direxion HI-FLO) is a large lumen microcatheter with a distal outside diameter of 2.9F (1.00 mm), and a maximum outside diameter of 3F (1.05 mm). It has an inside diameter of 0.027 in (0.6 mm) minimally in the proximal and distal regions. The microcatheter lumen is able to accommodate steerable guidewires with diameters ≤ 0.021 in (0.53 mm).

The Direxion and Direxion HI-FLO Microcatheters are available in a variety of tip shapes (Straight, Bern, Swan Neck, and J Shape) to aid with accessing challenging anatomy. The distal outer surface of the microcatheter is coated with a hydrophilic coating. A radiopaque marker is located at the distal tip to facilitate fluoroscopic visualization. Some Direxion Microcatheters have a second marker 3 cm proximal to the first marker. The distal tip of the microcatheter is steam shapeable. The proximal end incorporates a standard luer with rotating hemostatic valve (RHV) or Y-adapter.

The Direxion and Direxion HI-FLO Microcatheters are available with the following preloaded guidewires:

Fathom-16 Steerable Guidewire (K111485)

• 0.016 in (0.41 mm) diameter; 140 or 180 cm lengths

Transend 14/18 Steerable Guidewires (K971254 / K964611)

• 0.014 in (0.37 mm) or 0.018 in (0.47 mm) diameters; 135, 165 or 190 cm lengths

The guidewires have a hydrophilic coating to provide lubricity, which aids in the navigation of distal, tortuous vasculature. The guidewires are radiopaque to allow for visualization under fluoroscopy and the tips are shapeable.

Accessories may include a RHV or Y-adapter, steam shaping mandrel, microcatheter introducer, quidewire introducer and torque device.

The provided text describes a 510(k) premarket notification for microcatheters. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical or AI-centric studies. Therefore, many of the requested categories (e.g., effect size of human readers with AI assistance, algorithm-only performance, training set size, ground truth for training set) are not applicable to this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document mentions "bench testing was conducted for design elements and performance characteristics." However, it does not specify sample sizes for these tests, nor does it refer to a "test set" in the context of patient data or algorithm evaluation. Data provenance (e.g., country of origin, retrospective/prospective) is not applicable as this concerns bench testing of the physical device.

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

Not applicable. "Ground truth" in this context would refer to a benchmark for a diagnostic or AI device. This submission is for a physical medical device (microcatheter) where performance is evaluated through engineering and biocompatibility testing.

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

Not applicable. This concept belongs to studies where human experts or algorithms are evaluating data, typically for diagnostic accuracy.

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

Not applicable. This device is a microcatheter, not an AI-assisted diagnostic or treatment system.

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

Not applicable. This device is a microcatheter, not an AI algorithm.

7. The type of ground truth used

For the performance data listed, the "ground truth" is established through industry standards, engineering specifications, and validated test methods for material properties, functional performance (e.g., ID/OD dimensions, tensile strength, kink resistance, infusion pressure), compatibility, and biological safety.

8. The sample size for the training set

Not applicable. This device is a microcatheter, not an AI algorithm requiring a training set.

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

Not applicable. This device is a microcatheter, not an AI algorithm.

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