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The Clyde Coronary Guidewire is intended for use in percutaneous procedures to reach and cross stenotic lesions prior to the insertion of a coronary balloon dilation catheter.

The Clyde Coronary Guidewire is a 0.014" guidewire manufactured in lengths of 100-400 cm. The guidewire is made of a stainless steel, PTFE coated proximal shaft, which tapers down to a flexible distal tip. The tip area consists of a radiopaque tungsten spring coil. The distal 3 cm of the coil are very flexible and shapeable.

The provided text (K970528) describes a 510(k) submission for the "Clyde Coronary Guidewire." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance as would typically be seen for a new technology or algorithm.

Therefore, many of the typical clinical study parameters requested (such as acceptance criteria table, sample sizes, expert qualifications, MRMC study, standalone performance, ground truth types, and training set details) are not applicable or not present in this type of submission.

Here's a breakdown of the relevant information provided and why other requested details are absent:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable in this document. The submission focuses on demonstrating substantial equivalence to a predicate device (C-Thru Coronary Guidewire) based on design, materials, and intended use, rather than meeting specific quantifiable performance metrics through a clinical or algorithmic study with acceptance criteria.
• The "performance" discussed is related to the similarity in technological characteristics and a reduced biocompatibility battery.

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

• Not applicable. This submission doesn't describe a "test set" in the context of a performance study with patient data or an algorithmic evaluation. The assessment is primarily based on a comparison of device specifications and limited in-vitro testing.

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

• Not applicable. There is no "ground truth" establishment in the context of diagnostic accuracy or clinical outcome for this type of device submission. The evaluation is on the physical and material properties of the guidewire.

4. Adjudication Method for the Test Set:

• Not applicable. See point 3.

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

• No, not performed, and not applicable. This is a medical device (guidewire), not an AI/imaging diagnostic device. Therefore, a study involving human readers and AI assistance is irrelevant to this submission.

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

• No, not performed, and not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

• Not applicable. There is no "ground truth" in the sense of a reference standard for diagnostic performance. The "truth" in this context is the technical equivalence to a legally marketed device and compliance with material safety (biocompatibility).

8. Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not an algorithm requiring machine learning.

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

• Not applicable. See point 8.

Summary of Information from the Provided Text:

The document describes a 510(k) submission for a coronary guidewire, not an AI or diagnostic imaging device. The primary method for demonstrating safety and effectiveness is by proving substantial equivalence to a currently marketed predicate device.

Key takeaway from the provided information:

• Predicate Device: C-Thru Coronary Guidewire
• Method of Equivalence: Detailed comparison of design and materials between the Clyde and C-Thru coronary guidewires.
• Biocompatibility Testing: A reduced biocompatibility battery (consisting of hemolysis and cytotoxicity tests) was conducted due to the similarity in materials with the predicate device. The results indicated equivalence and safety.

This type of submission relies on showing that the new device is fundamentally similar to an already approved device, meaning it doesn't raise new questions of safety or effectiveness. Therefore, the detailed performance study parameters typically requested for new diagnostic algorithms or novel therapeutic devices are not present.

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