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The Traxcess Docking Wire is intended for general intravascular use, including the neuro and peripheral vasculature. The Traxcess Docking Wire can be used with Traxcess guidewires to facilitate the placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.

The Traxcess Docking Wire is an accessory used to extend the Traxcess guidewire. It consists of a stainless steel shaft with a nitinol pipe and is coated with PTFE and silicone.

Acceptance Criteria and Study for Traxcess Docking Wire

Based on the provided 510(k) summary for the Traxcess Docking Wire (K093647), the device's acceptance criteria and the study proving it meets these criteria are outlined below.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary only explicitly lists "Pass" as the result for each bench test, without providing numerical thresholds or detailed metrics for the "Pass" criteria. This is typical for 510(k) submissions where the focus is on substantial equivalence to a predicate device, rather than novel performance claims.

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

The provided document describes bench testing, meaning the "test set" refers to the physical samples of the Traxcess Docking Wire and associated components.

• Sample Size: The document does not specify the exact number of samples (e.g., number of wires or components) used for each bench test.
• Data Provenance: The data provenance is internal to the manufacturer, MicroVention, Inc., based in Tustin, California, U.S.A. The testing is prospective in the sense that it was conducted specifically for this 510(k) submission to demonstrate the device's performance.

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

For bench testing of a medical device like a guidewire, the "ground truth" is typically established by engineering specifications, industry standards, and regulatory requirements, not by clinical experts in the same way it would be for an AI diagnostic algorithm.

• Number of Experts: Not applicable in the context of clinical expert consensus for ground truth. The "experts" would be the design engineers, quality control personnel, and regulatory affairs specialists at MicroVention, Inc.
• Qualifications: These individuals would possess engineering, scientific, and regulatory expertise relevant to medical device design, manufacturing, and testing standards.

4. Adjudication Method for the Test Set

For bench testing, "adjudication" (e.g., 2+1, 3+1) is not typically applicable as it refers to reconciling differences in expert opinions for clinical data.

• Adjudication Method: Not applicable. The results are determined by objective measurements and adherence to pre-defined test protocols. Any discrepancies would be resolved through re-testing, investigation of methodology, or review by quality control/engineering.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was a MRMC study done?: No. This submission describes a physical medical device (guidewire) and its bench testing, not an AI diagnostic algorithm or a clinical study involving human readers interpreting cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Was a standalone study done?: No. This question is relevant for AI algorithms, not for physical medical devices undergoing bench testing. The "performance" being evaluated is the physical properties and functionality of the guidewire itself.

7. Type of Ground Truth Used

The ground truth for the bench tests is based on:

• Engineering Specifications: Internal design parameters and performance targets set by MicroVention, Inc.
• Industry Standards: Relevant ASTM, ISO, or other recognized standards for guidewires and medical devices.
• Regulatory Requirements: Compliance with FDA guidelines for device safety and effectiveness, often implicitly linked to the performance of the predicate device.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This concept is relevant for machine learning algorithms where a model is "trained" on a dataset. For a physical device, the "training" involves the design and manufacturing processes, which are informed by engineering principles and historical data on similar devices, rather than a quantifiable training set in the AI sense.

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

• How the Ground Truth for the Training Set Was Established: Not applicable in the conventional sense of AI/machine learning. The "ground truth" for the design and manufacturing processes would be established through a combination of:
  • Prior knowledge and experience: Accumulated expertise from developing previous guidewires and medical devices.
  • Research and development: Iterative design and testing phases.
  • Performance of the predicate device: The predicate device (Runthrough NS Extension Wire, K080563) serves as a benchmark for established safe and effective performance, influencing the design and performance targets of the Traxcess Docking Wire.

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The Traxcess Guidewire and Traxcess Docking Wire is intended for general intravascular use, including the neuro and peripheral vasculature. The wire can be steered to facilitate the selective placement of diagnostic or therapeutic catheters. This device is not intended for use in coronary arteries.

The Traxcess 14EX Guidewire consists of a 0.014" stainless steel shaft and a tapered The Traxcess 14EA Guidewire consisted organism and stainless steel coils. The distal coil minton the contains a lubricious hydrophilic coating, and the proximal shaft section is coated with PTFE and silicone.

The Traxcess Docking Wire is an accessory used to extend the Traxcess guidewire. It The Traxess Docking Which an use assist with a nitinol pipe and is coated with PTFE and silicone.

This is a 510(k) premarket notification for a medical device, the Traxcess 14EX Guidewire and Traxcess Docking Wire. The provided document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific performance metrics and acceptance criteria for a new AI/software-based device.

Therefore, the requested information elements related to AI device performance studies, such as sample sizes for test/training sets, data provenance, ground truth establishment, expert adjudication, or MRMC comparative effectiveness studies, are not applicable to this submission.

Here's the summary of the available information regarding acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Result" and lists "Pass" for each test. The implicit acceptance criterion for each test is that the device must "Pass". Specific quantitative acceptance ranges (e.g., "tensile strength > X N") are not detailed in this summary document.

2. Sample size used for the test set and the data provenance: Not applicable. This document describes bench testing of a physical medical device, not a performance study of an AI/software device using a test set 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, in the context of expert review for AI performance, is not relevant to bench testing of a guidewire.

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 not an AI/software device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the bench tests would be the established engineering specifications and performance standards for guidewires, against which the device's physical attributes and mechanical properties were measured.

8. The sample size for the training set: Not applicable. This is not an AI/software device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/software device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is detailed in the "Verification and Test Summary Table" provided in the document. This section lists various bench tests conducted on the Traxcess 14EX Guidewire and Traxcess Docking Wire.

Study Type: Bench Testing

Objective: To demonstrate the technological similarity and equivalency of the Traxcess 14EX Guidewire and Traxcess Docking Wire with predicate devices by verifying its physical and mechanical properties.

Methods: The device underwent a series of standard bench tests that assessed critical performance characteristics for a guidewire. These tests included:

• Physical attributes
• Distal tip tensile strength
• Tip flexibility
• Distal tip torque strength
• Coating adherence
• Torqueability
• Attachment with docking wire
• Docking wire tensile strength

Results: For all listed bench tests, the device "Passed," indicating that it met the pre-defined (though not explicitly detailed in quantitative terms in this summary) acceptance criteria for each test.

Conclusion: Based on these successful bench test results, the submission concludes that the Traxcess 14EX Guidewire and Traxcess Docking Wire are substantially equivalent to the predicate devices, sharing the same intended use, operating principle, basic design, similar construction and materials, and using the same packaging and sterilization processes.

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