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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 Bandit guidewire is intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.

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 and 300 cm lengths. The 200 cm length is compatible with a guidewire extension. 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 provided text is a 510(k) summary for the Bandit guidewire, which is a medical device. This document describes the device, its intended use, and how it was determined to be substantially equivalent to a predicate device.

Crucially, this document describes a medical device (a guidewire), not a software or AI-powered medical device. Therefore, many of the requested categories in your prompt (such as sample size for test/training sets, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this type of device and study. The "acceptance criteria" here refer to standard engineering and biocompatibility tests for a physical device, not performance metrics of a diagnostic or AI algorithm.

Here's a breakdown of the information that is available, and why other parts are not:

1. Table of Acceptance Criteria and Reported Device Performance

The study that proves the device meets the acceptance criteria:

The study refers to a series of bench performance tests and biocompatibility tests. This is a pre-clinical study (laboratory-based testing), not a clinical trial involving human subjects for performance evaluation in the context of AI.

The document states: "The technological differences between the subject and predicate device have been evaluated through bench tests to provide evidence that the Bandit guidewire is substantially equivalent to the predicate device. The device design was verified through the following tests: [list of bench tests]. The results of the verification tests met the specified acceptance criteria and did not raise different questions of safety and effectiveness."

For biocompatibility, it states: "The biocompatibility evaluation for the Bandit guidewire was conducted in accordance with the International Standard ISO 10993-1... The battery of tests included the following: [list of biocompatibility tests]. Passing results from biomaterial tests demonstrate that the Bandit guidewire is non-cytotoxic, non-sensitizing, non-irritating, non-systemically toxic, non-pyrogenic, non-hemolytic, not an activator of the complement system, and thromboresistant."

Information Not Applicable or Not Provided for this Device Type:

• 2. Sample sized used for the test set and the data provenance: Not applicable. These were laboratory bench and biocompatibility tests on physical device samples, not studies on "test sets" of data.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical guidewire is established through engineering and biological testing standards and measurements, not expert consensus on medical images or patient data.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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 is a physical medical device, not an AI or diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device, in the spirit of your question, is established by engineering specifications and international standards (e.g., ISO 10993-1) for physical performance and biological safety.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

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