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The R350 guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, including use in crossing de novo coronary chronic total occlusions (CTO).

The Spectre guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature. including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).

The Raider guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature, in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO).

The Bandit guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature. including use in crossing de novo coronary chronic total occlusions (CTO).

The Warrior guidewire is intended for use in percutaneous procedures to introduce and position cathers and other interventional devices within the coronary and peripheral vasculature, including use in crossing de novo coronary chronic total occlusions (CTO).

R350 Guidewire:
The R350 guidewire is an extended length (350 cm) guidewire with a 0.013″ maximum outer diameter (OD) (0.012" nominal OD). It is composed of a nitinol alloy mandrel with a straight, radiopaque 5 cm gold-coated tungsten coil distal tip. The proximal 150 cm of the R350 guidewire has a polytetrafluoroethylene (PTFE) coating, while the distal 200 cm has a hydrophilic coating.

Spectre Guidewire:
The Spectre guidewire is a nitinol and stainless-steel guidewire with a 0.014″ diameter and straight shapeable tip. It is available in 200 cm and 300 cm lengths. The distal 25 cm of the guidewire has a spring coil with a 3 cm platinum coil on the distal tip that is visible under fluoroscopic methods. The distal 42 cm of the guidewire has a hydrophilic coating and the proximal portion has a PTFE coating.

Raider Guidewire:
The Raider guidewire is a stainless-steel core guidewire with a maximum outer diameter of 0.014″ and a straight, shapeable tip. It is available in 200 cm and 300 cm lengths. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating. The 200 cm model has a modified proximal end to allow for guidewire extension.

Warrior Guidewire:
The Warrior guidewire is a stainless-steel core guidewire with a 0.014" diameter that tapers to a 0.009" diameter distal tip. It is available in 200 cm and 300 cm lengths. The distal 20 cm of the guidewire has a spring coil, of which the distal 2.5 cm is visible under fluoroscopic methods. The guidewire has a straight shapeable tip with a tip load of 14 grams. The distal portion of the guidewire has a hydrophilic coating and the proximal portion has a PTFE coating. The 200 cm model has a modified proximal end to allow for guidewire extension.

Bandit Guidewire:
The Bandit guidewire is a 0.014″ diameter stainless steel core guidewire with a 0.008″ diameter tapered distal tip. It is available in 200 cm lengths. The distal portion of the guidewire includes a radiopaque coil and is covered with a polymer jacket and hydrophilic coating. The proximal portion has a PTFE coating. The 200 cm length is compatible with a guidewire extension.

The information provided describes the acceptance criteria and a clinical study conducted to demonstrate the safety and effectiveness of several guidewires (R350, Spectre, Raider, Bandit, Warrior guidewires) for use in crossing de novo coronary chronic total occlusions (CTO).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• Successful recanalization (angiographic confirmation of crossing CTO and restoring blood flow)
• MACE (In-Hospital and 30-Day)
• Clinically significant perforation
• Technical Success | Successful recanalization: 140 (93.3%)
  MACE:
  In-Hospital: 29 (19.3%)
  30-Day: 0 (0.0%)
  Clinically Significant Perforations: 16 (10.7%)
  Technical Success: 140 (93.3%) |

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

• Sample Size for Test Set: 150 subjects.
• Data Provenance: Prospective, multi-center, single-arm study. The country of origin of the data is not explicitly stated in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The document describes a clinical study to evaluate the safety and effectiveness of the guidewires but does not specify the number of experts or their qualifications for establishing the ground truth of the outcomes. The endpoints (e.g., angiographic visualization, MACE) would typically be adjudicated by clinical experts, but this detail is not provided.

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

The document does not explicitly state the adjudication method used for the test set. It mentions "in-hospital MACE" as part of the primary endpoint, which would imply clinical events were assessed, but the process of adjudication (e.g., by an independent clinical events committee) is not detailed.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is a clinical trial evaluating the performance of medical devices (guidewires) in a procedural context, not an AI-assisted diagnostic study involving human readers.

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

This is not applicable. The study evaluates the performance of physical guidewire devices, not an algorithm.

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

The ground truth for the clinical study was based on clinical outcomes data and angiographic visualization. Specifically:

• Angiographic visualization of guidewire position (distal/proximal to CTO in the true vessel lumen).
• Absence of in-hospital Major Adverse Cardiac Events (MACE), which includes cardiac death, target lesion revascularization, or post-procedural MI (defined as CK-MB ≥ 3x ULN).
• Successful recanalization.
• Clinically significant perforations.

8. The sample size for the training set

This information is not applicable as the document describes a clinical trial for physical medical devices, not an AI model that requires a training set.

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

This information is not applicable as the document describes a clinical trial for physical medical devices, not an AI model that requires a training set.

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The R350 guidewire is indicated for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.

The R350 guidewire is 350 cm in length with a 0.013" maximum outer diameter (O.D) (0.012″ nominal O.D.). It is composed of a nitinol alloy mandrel with a straight, radiopaque 5 cm gold-coated tungsten coil distal tip. The proximal 150 cm of the R350 guidewire has a PTFE coating, while the distal 200 cm has a hydrophilic coating.

This document is a 510(k) premarket notification for a medical device called the R350 Guidewire. The content focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical acceptance criteria through a trial. As such, information regarding clinical study design, sample sizes, expert involvement, and ground truth establishment, which are typical for studies proving device performance, is largely not applicable in the context of this 510(k) submission.

Here's a breakdown of the requested information based on the provided text:

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

The document states that the "results of the design verification and validation tests met the specified acceptance criteria" for a series of mechanical and biocompatibility tests. However, the specific quantitative acceptance criteria and the numerical reported device performance for each test are not provided in this summary. Only the types of tests conducted are listed.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified for any of the listed tests. The document only mentions "device samples."
• Data Provenance: Not specified. Given that these are design verification and validation tests, they are likely performed in a laboratory setting by the manufacturer (Vascular Solutions, Inc. in Minneapolis, USA) during device development, which would make them prospective tests, but this is an inference.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. The ground truth for these engineering and biocompatibility tests is established by standardized testing methods and quantifiable metrics, not by expert consensus in a clinical context.

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

Not Applicable. As these are performance tests against engineering specifications and international standards, there is no adjudication by human experts in the way clinical studies are adjudicated. Results are determined by test equipment and adherence to predefined protocols.

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 guidewire, a physical medical instrument, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.

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

Not Applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for the tests performed is based on:

• Engineering Specifications: For mechanical tests like guidewire dimensions, torque, flex, fracture, etc.
• International Standards: Specifically, ISO 10993-1 for biocompatibility tests.

8. The sample size for the training set

Not Applicable. This is a physical medical device. There is no "training set" in the context of an AI algorithm.

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

Not Applicable. See point 8.

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