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ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation 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.

The ASAHI® PTCA Guide Wire ASAHI Gladius Mongo consists of a one-piece core wire and a distal coil assembly. The coil assembly consists of an inner coil and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of the ASAHI® PTCA Guide Wire ASAHI Mongo. The coil and distal portion of the quide wire are coated with polyurethane and then covered with hydrophilic coating. The proximal portion of the guide wire is coated with PTFE only. The ASAHI® PTCA Guide Wire ASAHI Mongo is available in various lengths. The shorter length device is designed for use with a commercially available ASAHI INTECC extension, wire.

The provided text describes the 510(k) premarket notification for the "ASAHI® PTCA Guide Wire ASAHI Gladius Mongo 14 and ASAHI Gladius Mongo 14 ES." This document pertains to a medical device (a guide wire), not an AI algorithm or a diagnostic tool. Therefore, the questions regarding acceptance criteria and studies for an AI/ML powered device, specifically those requiring information on human readers, ground truth establishment for AI training/test sets, and expert adjudication, are not applicable to this document.

The document focuses on demonstrating substantial equivalence of the new guide wire to a legally marketed predicate device (ASAHI® Fielder XT-A). It primarily relies on non-clinical testing/performance data to show that the new device functions as intended and has a similar safety and effectiveness profile.

Here's a breakdown of the relevant information provided, responding to the spirit of the request where applicable to a traditional medical device:

1. A table of acceptance criteria and the reported device performance:

The document lists the following non-clinical tests performed, implying that internal acceptance criteria were met. However, the specific quantitative acceptance criteria and the exact reported performance results (e.g., specific tensile strength values or torque strength ranges) are not detailed within this public summary. The statement is qualitative: "met all acceptance criteria and performed similarly to the predicate device."

Regarding the other questions, they are not directly applicable to this type of device submission:

• 2. Sample sized used for the test set and the data provenance: This refers to data for an AI model. For this physical device, "sample size" would refer to the number of devices tested for each non-clinical test. This specific number is not provided in the summary. Data provenance is not relevant for a physical device's bench testing.
• 3. Number of experts used to establish the ground truth... and qualifications: This is for AI performance evaluation. Not applicable.
• 4. Adjudication method... for the test set: This is for AI performance evaluation. Not applicable.
• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done...: This is for AI performance evaluation. Not applicable.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is for AI algorithm performance. Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This is for AI ground truth. For this device, "ground truth" would be established by validated test methods and engineering specifications.
• 8. The sample size for the training set: This is for AI model training. Not applicable.
• 9. How the ground truth for the training set was established: This is for AI model training. Not applicable.

In summary, the provided document is a 510(k) summary for a physical medical device (a guide wire), and the questions posed are primarily designed for the evaluation of AI/ML-powered medical devices. Therefore, most of the specific details requested regarding AI acceptance criteria, ground truth, and study design are not found within this document. The core of this submission is demonstrating substantial equivalence through a comparison of technological characteristics and non-clinical bench testing.

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ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation 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.

The ASAHI® PTCA Guide Wire ASAHI SION black consists of a core wire and a coil assembly. The coil assembly consists of an inner coil, safety wire, and an outer coil, soldered to the core wire. The distal portion of the coil is radiopaque so as to easily confirm its position under radioscopy. In addition, coatings are applied on the surface of the ASAHI® PTCA Guide Wire ASAHI SION black. The coil and distal portion of the quide wire are coated with polyurethane and then covered with hydrophilic coating. The proximal portion of the guide wire is coated with PTFE. The ASAHI® PTCA Guide Wire ASAHI SION black is available in various lengths and tip shapes. The shorter length device is designed for use with a commercially available ASAHI INTECC extension wire.

This document describes the premarket notification for the ASAHI® PTCA Guide Wire ASAHI SION black. It does not contain information about an AI/ML powered device, therefore no information regarding acceptance criteria or a study that proves the device meets acceptance criteria related to AI/ML device performance can be extracted.

The document discusses non-clinical laboratory testing performed on the guide wire to demonstrate substantial equivalence to predicate devices, but this is for a physical medical device, not a software or AI-based one. The types of tests conducted are standard for guide wires (e.g., tensile strength, torqueability, tip flexibility, etc.) and the conclusion is that the device met all acceptance criteria and performed similarly to predicate devices.

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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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This product is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

The ASAHI Peripheral Guide Wires in this submission have a coil-type distal end or a plastic covered-type distal end. The coil is partly or entirely radiopaque to facilitate selection of the blood vessel and confirmation of the position of the guide wire's distal end by fluoroscopy.

The core shaft surface is coated with Polytetrafluoroethylene (PTFE). About 2cm of the distal end can be shaped. ASAHI INTECC detachable extension wire (hereafter "extension wire") (previously cleared as part of K083145 and K101985) is available to connect with the proximal end of the guide wire with a length of less than 300 cm. The total length of the system after the connection with be 300cm to 400cm. Torque device may be included in the same package.

The ASAHI Peripheral Guide Wires in this submission have an overall length range of 200 to 300 cm and a nominal outer diameter range of 0.36 to 0.45 mm.

This document is a 510(k) summary for ASAHI Peripheral Guide Wires, which includes three models: ASAHI Gladius, ASAHI Halberd, and ASAHI Gaia PV. The purpose of this summary is to demonstrate substantial equivalence to legally marketed predicate devices.

Here's the breakdown of the acceptance criteria and study information provided:

1. A table of acceptance criteria and the reported device performance:

The document broadly states that "The in vitro bench tests demonstrated that the ASAHI Peripheral Guide Wire met all acceptance criteria and performed similarly to the predicate devices." However, specific numerical acceptance criteria for each test (e.g., minimum tensile strength in Newtons, or maximum torque strength in N/cm) are not explicitly listed in the provided text. The performance is reported qualitatively as "met all acceptance criteria and performed similarly."

2. Sample size used for the test set and the data provenance:

The document mentions "Non clinical laboratory testing was performed," which implies a test set. However, the sample size used for the test set is not specified. The data provenance is also not specified beyond being "non clinical laboratory testing." It does not mention the country of origin of the data or whether it was retrospective or prospective, as these are typically not applicable to bench testing of this nature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable or provided. For medical devices undergoing bench testing against engineering specifications, ground truth is established by physical measurements and engineering standards, not typically by expert review in the same way it would be for AI model validation in image interpretation, for example.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable or provided. Adjudication methods are typically relevant for human review of data, especially in clinical studies or when establishing ground truth for AI model training/testing. For bench testing, the results are typically objectively measured against established engineering specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable or provided. The device in question is a guide wire, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not applicable or provided. The device is a physical medical device (a guide wire), not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept for this product.

7. The type of ground truth used:

The ground truth for the bench tests would have been the engineering specifications and performance standards applicable to guide wires. These are based on industry standards, established medical device requirements, and the characteristics of the predicate devices.

8. The sample size for the training set:

This information is not applicable or provided. The document describes a physical medical device undergoing bench testing, not an AI system that requires a "training set."

9. How the ground truth for the training set was established:

This information is not applicable or provided for the same reason as point 8.

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