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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 Gladius Mongo18 PV ES is a steerable guide wire with a maximum diameter of 0.018 inches (0.45mm) and available in 190cm. 235cm and 300cm length. The distal end of the coil part is available straight and is made soft to easily bend with the vessel curve, or available pre shaped. The guide wire is constructed from a stainless-steel core wire with platinum-nickel coil. The coil is soldered to the core wire. The coil assembly consists of an inner coil and an outer coil, and the coil assembly is soldered to the core wire. The solder of distal end is Au-Sn and other solder is Ag-Sn. The distal end of the quide wire has a radiopaque tip to achieve visibility. For the models covered by this submission, a hydrophilic coating is applied to the quide wire along the distal structure. The proximal section of the guide wire is coated with PTFE. The purpose of these surface coatings is to provide lubricity when guide wire is passed through percutaneous catheters. The basic structure, construction, and coating of the ASAHI Gladius Mongo18 PV ES are unchanged from that previously described in the predicate ASAHI Gladius (K150445).

This document describes the premarket notification (510(k)) for the ASAHI Gladius Mongo18 PV ES, a catheter guide wire for peripheral vascular use. The submission argues for substantial equivalence to a predicate device (ASAHI Gladius, K150445) and several reference devices.

Here's a breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the ASAHI Gladius Mongo18 PV ES "met all acceptance criteria and performed similarly to the predicate device" in bench testing. However, it does not explicitly list the quantitative acceptance criteria for each test. Instead, it lists the types of tests performed.

2. Sample Size and Data Provenance for Test Set

• Sample Size for Test Set: The document does not specify the exact sample size for the non-clinical bench tests (e.g., how many guidewires were tested for tensile strength).
• Data Provenance: The studies were bench tests conducted following FDA guidance. The manufacturing company is ASAHI INTECC CO., LTD., located at 3-100 Akatsuki-cho, Seto-shi, Aichi 489-0071 Japan, implying the testing likely occurred in or under the purview of the company's R&D facilities. This is a pre-market, prospective evaluation of the device's physical and mechanical properties.

3. Number of Experts and Qualifications for Test Set Ground Truth

This submission is for a medical device (guide wire) and primarily relies on non-clinical bench testing rather than interpretation of diagnostic images or patient outcomes. Therefore, the concept of "ground truth" established by human experts in the way it applies to AI/software performance (e.g., radiologists for imaging studies) is not applicable here. The "ground truth" for these tests is the objective physical and mechanical properties measured on the device itself against established engineering specifications and performance criteria derived from the predicate device and FDA guidance.

4. Adjudication Method for Test Set

As the "ground truth" is established through objective bench testing measurements against pre-defined criteria, an adjudication method (like 2+1, 3+1 for human disagreements) is not applicable. The results are quantitative measurements.

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

• Was it done? No. This is a physical medical device (guidewire), not a diagnostic imaging AI or software. Therefore, an MRMC study involving human readers with and without AI assistance is not applicable.
• Effect Size: Not applicable.

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

• Was it done? This question typically applies to AI algorithms. For this physical medical device, the "standalone" performance refers to the device's inherent physical and mechanical properties as measured in bench tests, independent of its use by a human operator for the specific tests mentioned. The non-clinical bench testing effectively represents this "standalone" performance against established engineering criteria.

7. Type of Ground Truth Used

The ground truth for the non-clinical testing was based on objective engineering specifications, physical and mechanical measurements, and performance criteria derived from the predicate device's validated performance and FDA guidance documents.

8. Sample Size for the Training Set

• Sample Size: This device did not undergo a "training" process in the sense of a machine learning algorithm. The "training" for such a device would be its design, manufacturing processes, and quality control. There isn't a "training set" of data in the AI sense for this device.

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

• Not Applicable. As mentioned above, there is no "training set" for this type of device in the context of an FDA 510(k) submission for substantial equivalence based on bench testing. The design and manufacturing processes are validated to produce devices meeting pre-defined specifications.

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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), including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.

The ASAHI PTCA Guide Wire ASAHI Gaia Next (hereafter "ASAHI Gaia Next") is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 190cm length. The extension wire may be connected to the end of the guide wire outside the body. The guide wire is constructed from a stainless-steel core wire with a platinum-nickel 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 distal end of the quide wire has a radiopaque outer coil and inner coil to achieve visibility and can be made to bend easily with the vessel curve. A hydrophilic coating is applied to the distal portion of the guide wire. The coil assembly construction is similar to predicate device.

The provided text describes the 510(k) premarket notification for the ASAHI PTCA Guide Wire ASAHI Gaia Next. This document focuses on demonstrating substantial equivalence to a predicate device, not on presenting results from a study proving device performance against specific acceptance criteria for a new, novel technology. Therefore, many of the requested categories (such as sample size for test sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or not available from this regulatory submission. This document details non-clinical bench testing to show the device performs similarly to a predicate.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a table of precise quantitative acceptance criteria (e.g., "tensile strength must be >X Newtons") or specific numerical performance results for each test. Instead, it states that the device "met all acceptance criteria" and "performed similarly to the predicate devices" in bench testing.

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

• Sample Size for Test Set: Not specified. The document refers generally to "bench testing" without providing the number of units tested for each non-clinical performance test.
• Data Provenance: The tests are described as "in vitro bench tests." This implies tests were conducted in a laboratory setting. The country of origin of the data is not explicitly stated, but the applicant is ASAHI INTECC CO., LTD from Japan.

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

• Not Applicable. This device is a guide wire, and the evaluation involves non-clinical engineering and biological performance testing, not diagnostic interpretation requiring expert consensus on "ground truth."

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

• Not Applicable. As mentioned above, this is non-clinical bench testing. Adjudication methods are relevant for human-read diagnostic studies.

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

• Not Applicable. This is a medical device (guide wire), not an AI-powered diagnostic tool. No MRMC study was conducted.

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

• Not Applicable. This is a medical device (guide wire), not an AI-powered diagnostic tool. No standalone algorithm performance was evaluated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For the non-clinical bench tests, the "ground truth" or reference for acceptance is against established engineering and material science standards and performance specifications for guide wires, and comparison to the predicate device. For biocompatibility, it's against established biological safety standards.

8. The sample size for the training set

• Not Applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The testing described is for a physical medical guide wire.

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

• Not Applicable. See point 8.

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This product is intended for use in the percutaneous introduction of catheters. Not for use in the coronary arteries or intracranial vessels.

The ASAHI Silverway consists of a one-piece core wire and a coil assembly that extends the entire length of the device. The coil assembly consists of an inner coil and an outer coil, soldered to the core wire. In addition, coatings are applied on the surface of the ASAHI Silverway. The distal and proximal sections are coated with silicone. The intermediate section is coated with hydrophilic coating. The ASAHI Silverway has a nominal outer diameter of 0.89mm (0.035in) and is available in various lengths from 150cm to 300cm and tip shapes.

This document describes the premarket notification (510(k)) for the ASAHI® Silverway® guidewire. The acceptance criteria and study details are focused on non-clinical performance given the type of device and the 510(k) pathway, which establishes substantial equivalence rather than independent safety and effectiveness.

Here's a breakdown of the requested information based on the provided text:

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

The document states that the ASAHI Silverway "met all acceptance criteria" and "performed similarly to the predicate devices." While specific numerical acceptance criteria (e.g., minimum tensile strength in Newtons, maximum torque to twist in degrees) are not explicitly listed in the public summary, the general categories of tests performed indicate the areas for which acceptance criteria would have been established.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: The document does not explicitly state the specific number of units tested for each non-clinical test. It generally refers to "non-clinical laboratory testing."
• Data Provenance: The tests were "non-clinical laboratory testing" presumably conducted by or for ASAHI INTECC CO., LTD. Given the company's address (Japan), the testing was likely performed in Japan or by a qualified lab contracted by them. The studies are by nature prospective in that new guidewires were manufactured and then tested according to predefined protocols.

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

This section is not applicable to this type of regulatory submission. For a guidewire, "ground truth" is typically defined by engineering specifications, material properties, and performance benchmarks established through industry standards (e.g., ISO, ASTM) and comparison to predicate devices, rather than expert human interpretation of complex data (like medical images).

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

Not applicable. As this is non-clinical laboratory testing against pre-defined engineering and material standards, there is no need for expert adjudication in the way it might be applied to, for example, classifying medical images. Test results are objective measurements.

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

Not applicable. This device is a medical guidewire, not an AI/imaging device. Therefore, no MRMC study or AI assistance evaluation would be relevant or expected.

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

Not applicable. This device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on:

• Engineering specifications and design requirements: Did the device meet its designed dimensions, material properties, and functional characteristics?
• International standards: Adherence to relevant ISO (e.g., ISO 11070 for catheter guidewires, ISO 10993 for biocompatibility) and ASTM standards.
• Performance of predicate devices: Substantial equivalence is demonstrated by performing "similarly to the predicate devices." The predicates themselves would have established a benchmark for acceptable performance.

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no training set in the AI sense. The "training" in manufacturing comes from process validation and quality control, but not a data-driven model training.

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

Not applicable for the same reason as point 8.

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