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The 0.035" and 0.025" Guidewire is indicated for use in the peripheral vasculature. The 0.014", 0.016", and 0.018" guidewires are indicated for use in the peripheral and coronary vasculature.

The guidewire is constructed of nitinol (nickel-titanium alloy). The nitinol core extends from the distal tip of the guidewire to the proximal shaft end. The distal tip is a helically coiled coil gold plated tungsten wire. The guidewire is coated with a coating(s)to help facilitate smooth passage.

The provided document is a 510(k) Summary for the Nitrex™ Nitinol Guidewire, which details its substantial equivalence to predicate devices. It does not contain information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device performance study as typically understood for AI/ML-based medical devices.

Instead, the "Testing" section states: "Verification/validation testing demonstrated that devices utilizing the new coating formulation meet the original verification and validation requirements." This implies that the device (a guidewire) was evaluated against established engineering and performance specifications for medical guidewires, not against a clinical test set to assess AI diagnostic or prognostic accuracy.

Therefore, I cannot provide the requested information in the format of acceptance criteria and study details for an AI/ML device because the document describes a traditional medical device (a guidewire) approval process based on substantial equivalence and engineering verification/validation, not an AI/ML performance study.

If there were a different document related to an AI/ML device, I would be able to extract and present that information.

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The 0.035'' and 0.025'' Guidewire is indicated for use in the peripheral vasculature. The 0.014'', 0.016'', and 0.018'' guidewires are indicated for use in the peripheral and coronary vasculature.

The guidewire is constructed of nitinol (nickel-titanium alloy). The nitinol core extends from the distal tip of the guidewire to the proximal shaft end. The distal tip is a helically coiled coil gold plated tungsten wire. The guidewire is coated with a coating(s)to help facilitate smooth passage.

Here's an analysis of the provided text regarding the EV3 Nitrex™ Nitinol Guidewire.

Important Note: The provided document is a 510(k) summary for a medical device (guidewire). For this type of device, the "acceptance criteria" and "device performance" usually refer to engineering specifications and physical testing, not clinical performance metrics like sensitivity, specificity, or accuracy which are common for AI/diagnostic devices. Similarly, concepts like "ground truth," "experts," "adjudication," and "MRMC studies" are typically not applicable to guidewires.

The document describes a submission for substantial equivalence based on physical and dimensional testing, comparing it to predicate devices. It does not contain information about studies involving AI, human readers, or clinical outcomes that would typically have the metrics and study design elements requested in the prompt.

Given this context, I will extract the information that is present and indicate where the requested information is not applicable to this type of device submission.

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

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

• Sample Size: Not specified for dimensional or verification/validation testing.
• Data Provenance: Not specified, but likely internal testing by EV3 in the USA, as per their address. This is not a clinical study involving patient data.

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

• Not Applicable. This is a physical device, and "ground truth" in the diagnostic sense is not relevant. The "ground truth" for manufacturing would be adherence to engineering specifications and successful functional testing, typically performed by engineers/technicians.

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

• Not Applicable. Adjudication is not relevant for dimensional and functional testing of a guidewire.

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

• No. This is not an AI or diagnostic device.

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

• No. This is not an AI or algorithm-based device.

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

• Not Applicable. The "ground truth" for this device relates to its physical properties meeting design specifications and its functional performance during testing (e.g., ability to advance smoothly, tip flexibility, etc.) compared to predicate devices.

8. The sample size for the training set

• Not Applicable. This is not an AI or learning-based system.

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

• Not Applicable. This is not an AI or learning-based system.

Summary of Device and Study (Based on 510(k) Summary):

The EV3 Nitrex™ Nitinol Guidewire is a Class II medical device used in peripheral and coronary vasculature. The submission (K031864) is for substantial equivalence to existing predicate guidewires. The "study" mentioned is internal "dimensional inspection" and "verification/validation testing" performed by the manufacturer, EV3. The stated outcome is that "All testing of the product yielded acceptable results" and modifications did not affect original results, leading to the FDA's finding of substantial equivalence based on intended use, materials, labeling, and principles of operation being similar to predicate devices. No clinical trial, AI component, or human reader study is described in this document.

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The 0.035" and 0.025" Guidewire is indicated for use in the peripheral vasculature. The 0.014", 0.016", and 0.018" guidewires are indicated for use in the peripheral and coronary vasculature.

The guidewire is constructed of nitinol (nickel-titanium alloy). The nitinol core extends from the distal tip of the guidewire to the proximal shaft end. The distal tip is a helically coiled coil gold plated tungsten wire. The guidewire is coated with a coating(s)to help facilitate smooth passage.

This document is a 510(k) summary for the Nitrex™ Nitinol Guidewire, submitted to the FDA in 2003. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a comprehensive study report for new device performance metrics in the way a modern AI/ML device submission would.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that "All testing of the product yielded acceptable results." However, it does not explicitly list quantitative acceptance criteria for each specific test (e.g., "tensile strength > X N," "coating adhesion > Y score"). The acceptance criteria are implied to be adherence to internal specifications and relevant standards. This is common for predicate-based medical device submissions that focus on substantial equivalence.

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

The document does not specify sample sizes for any of the performance tests. It also does not mention data provenance (e.g., country of origin, retrospective or prospective nature). The testing appears to be conducted in a laboratory setting (in-vitro and simulated conditions).

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

This information is not applicable and not provided in this type of submission. This document describes the testing of a physical medical device (guidewire), not an AI/ML algorithm that requires expert-established ground truth from a dataset.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As explained above, this is for a physical device, not an AI/ML algorithm requiring expert adjudication of data.

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

There was no MRMC comparative effectiveness study done. This type of study is relevant for AI/ML devices that assist human readers (e.g., radiologists, pathologists). The Nitrex™ Nitinol Guidewire is a physical interventional device, not an AI diagnostic or assistance tool.

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

There was no standalone (algorithm only) performance study done. This is not an AI/ML device. The "standalone performance" here refers to the guidewire's physical characteristics and functionality.

7. The Type of Ground Truth Used

The "ground truth" for this device's testing would be defined by engineering specifications, material science standards, and established in-vitro performance test methods. For example, the "ground truth" for tensile strength would be the measured force at which the guidewire breaks, compared against a pre-defined acceptable range. For biocompatibility, the ground truth is adherence to ISO 10993-1 guidelines and testing results.

8. The Sample Size for the Training Set

There is no training set for this device. This is a physical medical device, not an AI/ML algorithm that undergoes training.

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

This question is not applicable as there is no training set mentioned for this physical medical device.

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