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The Medtronic Archer 0.035 inch (0.89 mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta, where increased support, distal flexibility, and low surface friction of the guidewire is needed.

The Medtronic Archer Super Stiff Guidewire is a PTFE coated stainless steel guidewire. The Archer Super Stiff Guidewire is offered in 200cm and 260cm lengths and incorporates a flexible tip section and inner 8cm radiopaque spring for enhanced visibility. The Archer Super Stiff guidewire is offered in single and double curve tip configurations. The Archer Super Stiff guidewire is sterile, non-pyrogenic, disposable and for single use only.

The Medtronic Archer Super Stiff Guidewire (K101339) is a medical device for facilitating catheter placement and exchange. The acceptance criteria and the study proving it meets these criteria are described below:

1. Acceptance Criteria and Reported Device Performance

The document summarizes non-clinical data, implying that the device's performance was compared to established standards and predicate devices (Cook Lunderquist Wire Guide (K061670) and Boston Scientific Corporation Back-Up Meier Steerable Guidewire (K020283)). The acceptance criteria are implicitly met if the device demonstrates "substantial equivalence" to these predicates through various bench tests and biocompatibility testing. No specific numerical acceptance criteria (e.g., minimum tensile strength value) are provided in the summary; instead, the overall conclusion states that the test results "verify that the Archer Super Stiff Guidewire is substantially equivalent to the predicate devices and is adequate for its intended use."

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

The provided 510(k) summary does not specify the exact sample sizes for each non-clinical bench test or the animal study. It generally states that "Non-clinical verification and validation...consists of the following in vitro bench tests" and "in-vivo pre-clinical (Animal Study) testing was performed."

The data provenance is not explicitly stated in terms of country of origin. The studies are described as "in vitro bench tests" and "in-vivo pre-clinical (Animal Study) testing," implying that they were conducted in a controlled environment, likely by the manufacturer (Medtronic Vascular) or a contracted lab. These are prospective studies designed to evaluate the new device.

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)

This section is not applicable. The device is a guidewire, and its performance evaluation in this 510(k) relies on objective physical and chemical testing (bench tests, biocompatibility tests), and an animal study. There is no mention of human expert assessment or review of images/cases to establish ground truth as would be the case for an AI-powered diagnostic device.

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

This section is not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, often in diagnostic imaging or clinical trials. The studies described are objective bench tests and animal studies where measurements and observations are made against predefined criteria, not requiring an adjudication process.

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 section is not applicable. The device is a guidewire, not an AI-powered diagnostic tool. Therefore, no MRMC comparative effectiveness study was performed to assess human reader improvement with AI assistance.

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

This section is not applicable. The device is a physical medical instrument (guidewire), not an algorithm or software. Therefore, no standalone algorithm performance study was conducted.

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

The "ground truth" for the performance evaluation of the guidewire was primarily based on:

• Engineering Specifications and Industry Standards: For the dimensions and mechanical properties, the "ground truth" would be the engineered specifications of the device and adherence to relevant industry standards for guidewire performance.
• Biocompatibility Standards: Ground truth for biocompatibility was established by recognized international standards (e.g., ISO 10993-1 and ASTM standards).
• Predicate Device Performance: Implicitly, the performance of the legally marketed predicate devices (Cook Lunderquist Wire Guide and Boston Scientific Corporation Back-Up Meier Steerable Guidewire) also served as a "ground truth" or benchmark for demonstrating substantial equivalence. The new device was shown to have "similar materials of construction" and "the same technological characteristics" as the predicates.
• Pre-clinical Animal Study Observations: For the in-vivo evaluation, the ground truth would be observations and measurements of the device's behavior and effects within a living system, assessed against expected physiological responses and safety parameters.

8. The sample size for the training set

This section is not applicable. The device is a physical medical guidewire, not a machine learning model. Therefore, there is no "training set" in the context of AI.

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

This section is not applicable, as there is no "training set" for this type of device.

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