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ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

As a basic structure, the Fielder XT-A, Fielder XT-R, consists of a taper core wire and 2 types coils (a tapered outer coil and an inner rope coil). The taper core wire and the coils are soldered together. The coil is radiopaque so as to easily confirm its position under radioscopy.

The coil and distal part of tapered core wire of the products are coated with polyurethane and then covered with hydrophilic polymer. The proximal end of the tapered core wire is coated with PTFE.

The nominal outer diameter of both the Fielder XT-A and Fielder XT-R is 0.36mm. with a distal diameter of 0.26mm. Both the Fielder XT-A and Fielder XT-R are available in 190cm and 300cm, total length. The tip shape is straight.

The provided document does not contain an acceptance criteria table with reported device performance for a medical device. Instead, it is an FDA 510(k) summary for the ASAHI Fielder XT-A and ASAHI Fielder XT-R guide wires, demonstrating substantial equivalence to predicate devices. The document outlines general testing performed but does not provide specific quantitative acceptance criteria or detailed results.

However, based on the information provided, here's a breakdown of what is available regarding testing and equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "The in vitro bench tests demonstrated that the ASAHI Fielder XT-A and ASAHI Fielder XT-R met acceptance criteria and performed similarly to the predicate devices."

It does not provide a table with specific quantitative acceptance criteria or the numerical results of the device's performance against those criteria. It only lists the types of tests performed.

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

• Sample Size for Test Set: The document does not specify the exact sample size for each bench test performed (Dimensional Verification, Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Adhesion, Catheter Compatibility, Coating Integrity / Particulate testing).
• Data Provenance: The tests were "Non clinical laboratory testing" performed by "ASAHI INTECC CO.,LTD" (applicant). The company is based in Nagoya, Aichi, Japan, with research facilities and factories in Osaka, Seto, Thailand, and Hanoi, suggesting the testing likely occurred in one of these locations. The data is retrospective for the purpose of this 510(k) submission.

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

This information is not applicable and therefore not provided. The testing described is bench testing of physical device characteristics, not clinical studies requiring expert interpretation of patient data to establish ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable as the testing involves objective physical measurements and comparisons to predicate devices, not subjective interpretations requiring adjudication.

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

No MRMC study was done. The device is a PTCA guide wire, and its performance is evaluated through bench testing and comparison to existing predicate devices, not through a comparative clinical effectiveness study with human readers interpreting imaging.

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

This question is not applicable. The device is a physical medical device (guide wire), not an algorithm or AI system. Its performance is inherent to the device itself.

7. Type of Ground Truth Used:

The "ground truth" for the bench tests was based on predetermined acceptance criteria for physical and mechanical properties, likely derived from engineering specifications and performance characteristics of functionally equivalent predicate devices. For example, a certain tensile strength or torqueability range would be considered acceptable based on established standards for guide wires.

8. Sample Size for the Training Set:

This information is not applicable. There is no training set mentioned or implied as this is not an AI/ML device.

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

This information is not applicable, as there is no training set.

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