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ASAHI Peripheral Vascular Guide Wire is intended for use in the peripheral vasculature, to facilitate the exchange and placement of diagnostic and therapeutic devices such as vascular catheters during peripheral interventional procedures. This guide wire is not intended for use in neuro- or coronary vasculature.

Device Description

The ASAHI CHIKAI V Peripheral Vascular Guide Wire is a steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 165 cm and 180 cm lengths. The guide wire is constructed from a stainless steel core wire with platinumnickel and stainless steel coils. The coil assembly consists of an inner coil and an outer coil, and the coil assembly is soldered to the core wire. The coil assembly construction is the same as the 510k cleared ASAHI CHIKA! Neurovascular Guide Wire with K110584. The distal end of the guide wire has a radiopaque tip to achieve visibility, and is available in a straight configuration and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion and core wire of the guide wire.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ASAHI CHIKAI V Peripheral Vascular Guide Wire:

1. Table of Acceptance Criteria and Reported Device Performance:

The document details performance testing conducted for the ASAHI CHIKAI V Peripheral Vascular Guide Wire, but it does not explicitly state specific numerical acceptance criteria for each test. Instead, it describes that the device "meets all predetermined performance criteria" and "performs as intended." The reported performance is generally a qualitative statement of meeting these criteria.

Acceptance Criteria (Explicitly Stated)	Reported Device Performance
Not explicitly stated for individual tests. The document indicates the device must "meet all predetermined performance criteria" and "perform as intended."	The ASAHI CHIKAI V Peripheral Vascular Guide Wire meets all predetermined performance criteria and performs as intended.
Tensile Strength	Successfully tested and performed as intended.
Turns to Failure (Torque Strength)	Successfully tested and performed as intended.
Torqueability (Torque Response)	Successfully tested and performed as intended.
Tip Flexibility	Successfully tested and performed as intended.
Coating Adhesion	Successfully tested and performed as intended.
Slipping Ability of Guide Wire with Microcatheter	Successfully tested and performed as intended.
Particulate Testing	Successfully tested and performed as intended.
Biocompatibility (Systemic Toxicity, In Vitro Hemolysis, Intracutaneous Study, Cytotoxicity, Sensitization, Pyrogen, Plasma Recalcification Time, Coagulation, In Vivo Thromboresistance, C3a Complement Activation, SC5b-9 Complement Activation)	Established by successful use of the same materials and manufacturing process in predicate devices and leveraged from those predicate devices.

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

The document does not specify the sample sizes used for the in vitro bench tests. It also does not mention the country of origin of the data or whether the tests were retrospective or prospective. Given these are bench tests, they are inherently prospective in their execution.

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

This information is not applicable to this submission. The tests performed are engineering-based bench tests (tensile strength, torque, flexibility, etc.) and biocompatibility studies. These types of tests do not typically involve human expert interpretation to establish a "ground truth" in the way a diagnostic study would (e.g., radiology image interpretation).

4. Adjudication Method for the Test Set:

This information is not applicable as the tests are not diagnostic or interpretive in nature requiring an adjudication process.

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

No, an MRMC comparative effectiveness study was not conducted or reported. This device is a medical instrument (guide wire), and its performance is evaluated through engineering bench tests and biocompatibility, not by comparing human reader performance with and without AI assistance.

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

This question is not applicable as the device is a physical medical instrument and does not involve an algorithm or AI. The tests performed are inherently "standalone" in that they evaluate the physical properties and performance of the device itself.

7. Type of Ground Truth Used:

For the bench tests, the "ground truth" is established by the physical properties and functional performance measures defined by engineering standards and internal specifications for guide wires. For biocompatibility, the ground truth is established by validated laboratory assays and established safety profiles of the materials used, often leveraged from predicate devices with a history of safe use.

8. Sample Size for the Training Set:

This question is not applicable as the device is a medical instrument, not an AI or machine learning model that would require a training set.

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

This question is not applicable as there is no training set for this device.

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