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SCIMED 7 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 7 F Wiseguide guide catheter utilizes common 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 a distal curve area of the catheter with transitional flexibility.

The distal tip 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 medical device in question is the SCIMED® 7 French Wiseguide™ Guide Catheter, which is similar to Diagnostic Intravascular Catheters (21CFR Part 870.1200).

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided document describes non-clinical (in-vitro) testing. Therefore, there were no human patient test sets used. The document does not specify the exact sample sizes (number of units tested) for each functional test mentioned.

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

Not applicable. This was an in-vitro functional testing study of a medical device, not a study requiring human expert assessment for ground truth.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or clinical outcomes, which is not the case for this in-vitro functional testing.

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

No. The document only describes non-clinical (in-vitro) functional testing, not a comparative effectiveness study involving human readers or cases.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. This is a physical medical device, not an algorithm, so a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used:

The "ground truth" for this study was established through engineering specifications and performance standards for various physical and mechanical properties of the catheter. The functional tests (e.g., pressure burst, tensile strength, torque response) directly measured whether the device met these predefined engineering requirements.

8. Sample Size for the Training Set:

Not applicable. This document describes the functional testing of a specific medical device, not the development or training of a machine learning algorithm.

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

Not applicable, as there was no training set for an algorithm. The "ground truth" for the device's design and performance expectations would have been established during its development based on engineering principles, predicate device performance, and the intended clinical use.

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