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The mechanical guidewire is intended for complex diagnostic and interventional procedures where increased body. flexibility, and low surface friction of the wire guide are needed. The guidewire is intended for perpheral vasculature use only, not intended for coronary or neurovascular use.

The Mechanical Guidewire consists of a stainless-steel core wire with a flexible, J-tip stainless steel distal tip. A green polytetrafluoroethylene (PTFE) coating is present on the entire length of the guidewire and provides a lubricious surface for tracking through compatible ancillary devices. The distal curve allows visualization under appropriate imaging guidance during diagnostic and interventional procedures. The device is offered in a 180 cm length, with two outside diameters (0.032″ and 0.035″), and one distal curve shape (1-tip). The tip curve radius for the Mechanical Guidewire measures 3 mm.

The provided text is a 510(k) Summary for a medical device called the "Mechanical Guidewire." This document focuses on demonstrating substantial equivalence to a predicate device, not on proving that a new AI/Software device meets specific acceptance criteria through a study.

Therefore, the input does not contain the information necessary to answer the questions about acceptance criteria for an AI/Software device, its performance, a test set, ground truth establishment, MRMC studies, or training sets. The document describes standard performance testing for a physical medical device (guidewire), such as mechanical testing, biocompatibility, sterilization, and packaging.

Specifically:

• 1. A table of acceptance criteria and the reported device performance: This document lists various mechanical, physical, biocompatibility, and sterilization tests performed on the guidewire. It states "All test requirements were met as specified by applicable standards and test protocols." However, it does not provide a table of specific acceptance limits and the quantitative results for each test. More importantly, these are physical device tests, not acceptance criteria for an AI/software device.
• 2. Sample sizes used for the test set and the data provenance: Not applicable. This document describes testing of a physical medical device, not an AI/software device with 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 for an AI/software device is not relevant to the testing described here for a mechanical guidewire.
• 4. Adjudication method for the test set: Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned as this relates to human reader performance with AI assistance, which is not relevant to a mechanical guidewire.
• 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: Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes the regulatory clearance process for a physical medical device (a guidewire) by demonstrating substantial equivalence to a predicate device through various physical, mechanical, and biological tests. It does not pertain to the evaluation of an AI or software device, and thus the questions regarding acceptance criteria, test sets, ground truth, and human reader studies for AI/software are not answerable from this document.

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The device is intended for complex diagnostic and interventional procedures where increased body, flexibility, and low surface friction of the wire guide is needed.

The subject device, the Lunderquist Extra Stiff DC Wire Guide with an extended double curved tip, is considered a line extension of the predicate Lunderquist Extra Stiff DC Wire Guides. The subject device is a PTFE-coated 0.035 inch stainless steel wire with a 4 cm flexible tip that includes an inner gold coil for enhanced visibility. The length of the device is either 260 cm or 300 cm and the J-curve radius is 15 mm. The devices have the body and stiffness required to control large diameter, stiff devices without causing damage to the patient's anatomy or the lumen of the delivery system.

The provided text describes a 510(k) premarket notification for a medical device, the Lunderquist Extra Stiff Wire Guide. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria in the manner of an AI/software device.

Therefore, the information required to answer your questions regarding acceptance criteria and a study proving device capability, specifically for an AI device, is not present in this document. This document pertains to a traditional medical device (a guide wire), not an AI-powered device.

Here's why the required information is absent:

• Type of Device: The Lunderquist Extra Stiff Wire Guide is a physical medical instrument. The questions you've posed (acceptance criteria for AI, training sets, adjudication, MRMC studies, ground truth establishment) are relevant to the validation of AI/Machine Learning devices.
• Regulatory Pathway: A 510(k) submission for a physical device emphasizes performance data to show the device functions as intended and is as safe and effective as a legally marketed predicate device. This is different from the rigorous clinical validation required for many AI/ML-based medical devices, which would involve the type of studies you're asking about.
• Performance Data Provided: The "Performance data" section (page 5) lists various physical tests (Biocompatibility, Surface test, Tape adhesion, Friction, Flexing, Peak tensile force, Ultrasound test, Simulated Use Test, Torque test). These are standard engineering and material tests for a wire guide, not AI model performance metrics. Each test simply states "The predetermined acceptance criteria were met," without detailing what those criteria were or specific performance values.

In summary, this document does not contain the information needed to answer your questions about acceptance criteria and study data for an AI device.

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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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