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SCIMED 6 French Wiseguide guide catheter is intended for use in general intravascular and coronary applications. It provides a pathway through which medical instruments, such as stents, balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. This device is not intended for use in the cerebral vasculature.

The shaft of the 6 F Wiseguide guide catheter utilizes biocompatible materials and consists of the following three layers: 1) the inner layer that provides a low coefficient of friction and facilitates passage of medical devices such as stents, balloon dilatation catheters, guide wires or other therapeutic devices, 2) the middle layer that extends from the shaft to the tip to provide kink resistance and torque control; and 3) the outer layer which provides stiffness, backup support, curve retention and radiopacity.

In addition, the outer primary catheter shaft is constructed of various material durometers providing transitional flexibility to the distal curve area of the catheter.

The catheter is radiopaque to allow visualization under fluoroscopy during a procedure.

The devices will be provided sterile and are intended for one procedure use only.

The provided text describes the 510(k) notification for the SCIMED® 6 French Wiseguide™ Guide Catheter. It outlines the device's description, intended use, and a summary of non-clinical testing. However, it does not contain the level of detail typically found in a study report proving acceptance criteria for an AI/ML medical device.

Based on the provided text, the device is a physical medical device (guide catheter), not an AI/ML-driven software device. Therefore, many of the requested criteria (e.g., sample sized for the test set, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable.

Here's the information that can be extracted and a clear indication of what is not present due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation of "Verified": The document states: "Test results verified that the 6 F Wiseguide catheter is adequate for its intended use." Specific quantitative acceptance criteria (e.g., "pressure burst > X PSI") and the exact numerical results are not provided in this summary.

2. Sample size used for the test set and the data provenance:

• Not applicable as this is a physical medical device. Testing involved physical device properties rather than a data-based test set.

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

• Not applicable as this is a physical medical device. Ground truth is based on engineering specifications and physical testing standards.

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

• Not applicable as this is a physical medical device.

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 device is a guide catheter and does not involve AI or human "readers."

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• The ground truth for this device's performance is based on engineering specifications and established functional performance standards for guide catheters, verified through non-clinical laboratory testing.

8. The sample size for the training set:

• Not applicable. This is a physical medical device; there is no training set in the context of AI/ML.

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

• Not applicable. This is a physical medical device; there is no training set in the context of AI/ML.

Summary of Non-Clinical Testing Section for Confirmation:

The document clearly states: "Functional testing consisted of pressure burst, tip bond tensile, shaft tensile, hub tensile, material adhesion, tip coefficient of friction, force transmitted by catheter tip, torque response and dye flow. Test results verified that the 6 F Wiseguide catheter is adequate for its intended use." This confirms the assessment that the acceptance criteria are related to the physical and mechanical properties of the catheter, not to AI/ML performance metrics. The device's equivalency was established by comparing its intended use, design, and in-vitro testing results to existing predicate devices.

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