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KDL Angiography Catheter are intended for delivery of radiopaque contrast media to selected sites during the angiography procedure of the peripheral and coronary vascular system.

The proposed device consists of tube hub, strain relief, catheter shaft with stainless steel braid layer, soft extension and distal tip. The catheter shaft is made of Pebax contain Barium Sulfate that is radiopaque and a middle stainless steel braid layer. Soft extension and distal tip is made of Pebax contain Barium Sulfate without stainless steel braid layer that could prevent vascular injury when pushed into the blood vessel.

The distal tip of the catheter is available in 32 kinds tip shape configurations. The outer diameter is available in 4F, 5F, 6F, 7F sizes and the length is available in 100cm except for Pig angiography catheter in length of 110cm. The side hole on distal tip is used to disperse the contrast media and balance pressure.

The provided text is related to the FDA 510(k) premarket notification for a medical device: the KDL Angiography Catheter. This document demonstrates the substantial equivalence of the proposed device to legally marketed predicate devices, rather than proving the device meets specific acceptance criteria through a study involving AI-driven performance or human reader improvements.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria, specifically in the context of AI performance, human reader studies (MRMC), or a comprehensive ground truth establishment process for a diagnostic algorithm, is not contained within the provided document.

The document primarily focuses on:

• Device Description: Physical characteristics, materials, sizes, and configurations.
• Intended Use Statement: Delivery of radiopaque contrast media during angiography.
• Substantial Equivalence Comparison: A detailed table comparing the proposed device with predicate and reference devices across various parameters like product code, indications for use, principle of operation, design, dimensions, materials, and sterilization methods.
• Performance Data (Nonclinical Bench Testing): A list of physical and chemical tests performed to ensure the device meets engineering specifications (e.g., burst pressure, flexibility, guidewire compatibility).
• Biocompatibility Testing: Compliance with ISO 10993 standards, including in vitro and in vivo tests for hemolysis, toxicity, sensitization, etc.

Since the request is about AI performance, human reader studies, and related metrics for a diagnostic device, and the provided document describes an Angiography Catheter (a physical medical instrument for delivering contrast), the requested information as described (AI performance, MRMC study, ground truth for AI, training set, etc.) is not applicable to this submission.

The document is a regulatory submission for a physical device, not a diagnostic algorithm or AI product.

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