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The ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters are intended to be used to guide interventional devices for neurovascular therapy to a lesion or a procedural site for a percutaneous intravascular in the neurovasculature. This catheter is also intended to be used for injection of contrast media. Do not use this cather other than for use in the neurovasculature.

ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters consists of a guide catheter, available in the following sizes: ASAHI FUBUKI 043 (4.2 Fr), ASAHI FUBUKI 6Fr (6 Fr), ASAHI FUBUKI 7Fr (7 Fr), ASAHI FUBUKI 8Fr (8 Fr). The ASAHI FUBUKI Neurovascular Guide Catheter Dilator Kit consists of a Catheter and Dilator components, available in the following sizes: ASAHI FUBUKI Dilator Kit 4Fr (Catheter 6 Fr, Dilator Shaft 1.75 mm), ASAHI FUBUKI Dilator Kit 5Fr (Catheter 7 Fr, Dilator Shaft 2.00 mm), ASAHI FUBUKI Dilator Kit 6Fr (Catheter 8 Fr, Dilator Shaft 2.21 mm). The catheter consists of three main sections including a tube, a protector section, and a connector. The proximal part of the tube is covered by the protector and the connector is bonded to the proximal end of the tube. A soft tip is bonded to the distal end of the catheter. The inner lumen of the tube (excluding the connector portion) is lined with PTFE to facilitate movement of the guide wire and other devices. The tube is made of polymer resin and is reinforced by a stainless steel and tungsten braid wire. The outer surface of the tube is partially coated with a hydrophilic polymer.

The provided document discusses a 510(k) premarket notification for the "ASAHI FUBUKI 043 and ASAHI FUBUKI Guide Catheters." This is a regulatory submission to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, not a study designed to prove the device meets acceptance criteria in the context of an AI/ML medical device.

The document describes non-clinical testing performed on the device to establish substantial equivalence to predicate devices, but it does not contain information regarding acceptance criteria for an AI/ML device, nor does it detail a study proving an AI/ML device meets such criteria.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample sizes for a test set or data provenance for an AI/ML model.
• The number or qualifications of experts used to establish ground truth for an AI/ML test set.
• Adjudication methods for an AI/ML test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes for AI assistance.
• Details about a standalone (algorithm-only) performance study for an AI/ML device.
• The type of ground truth used for an AI/ML model (e.g., pathology, outcomes data).
• The sample size for a training set (relevant for AI/ML).
• How ground truth for a training set was established (relevant for AI/ML).

Instead, the document focuses on non-clinical laboratory testing to compare the new catheter device to existing predicate devices. The tests performed are related to the physical and mechanical properties of the catheter, as listed under "NON CLINICAL TESTING / PERFORMANCE DATA":

• Corrosion resistance
• Force at break
• Liquid leakage under pressure
• Air leakage into hub assembly during aspiration
• Leak and damage under high static pressure
• Radio-detectability
• Kink resistance
• Appearance/Dimensions
• Biocompatibility

The conclusion drawn is that the new catheter device is "substantially equivalent" to the predicate devices based on shared intended use, technological characteristics (components, design, materials, sterilization, shelf life, operating principles), and performance data demonstrating it functions as intended with a similar safety and effectiveness profile.

Therefore, I cannot provide the requested information as it pertains to AI/ML device acceptance criteria and study details because the provided text describes a 510(k) submission for a physical medical device (catheter), not an AI/ML-driven device.

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