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This guide wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.

The CHIKAI Nexus 014 consists of a stainless-steel tapered core wire, with an inner coil and outer coil made of radiopaque Pt-Ni alloy and stainless-steel. Surrounding the inner coil and the distal core wire is a radiopaque Pt-Ni alloy and stainless-steel outer coil. The radiopaque distal tip enables the user to view the position of the tip under X-ray fluoroscopy. Outer and inner coils are soldered to the tapered core wire with Ag-Sn solder. A similar coil design is used with other ASAHI guide wires, such as the predicate CHIKAI black (K141751).

Additionally, the CHIKAI Nexus 014 employs hydrophilic, polyurethane, PTFE, and silicone coatings which are used in the predicate and reference devices.

The nominal outer diameter of the CHIKAI Nexus 014 is 0.36 mm (0.014 inch). The device is available in two lengths: 215 cm and 300 cm.

Both sizes are available with straight, pre-shape, and angled designs.

Acceptance Criteria and Study to Prove Device Meets Criteria for CHIKAI Nexus 014

The provided FDA 510(k) clearance letter and summary for the CHIKAI Nexus 014 detail performance testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating human reader performance with an AI device. The CHIKAI Nexus 014 is a catheter guide wire, a physical device, and not an AI/software as a medical device (SaMD) that would involve human readers or AI-assisted interpretation of images.

Therefore, many of the requested categories (e.g., number of experts, adjudication methods, MRMC study, standalone performance for an algorithm, ground truth for training/test sets for an AI) are not applicable to the information provided for this specific physical medical device.

The acceptance criteria and performance data provided relate to the physical and functional characteristics of the guide wire.

1. Table of Acceptance Criteria and Reported Device Performance

Device: CHIKAI Nexus 014 (Catheter Guide Wire)

Study Proving Device Meets Acceptance Criteria

The study described is a series of non-clinical, bench-top performance tests, and biocompatibility assessments comparing the CHIKAI Nexus 014 to its predicate device, the ASAHI Neurovascular Guide Wire CHIKAI black (K141751), and other reference devices. The goal was to establish substantial equivalence for a physical medical device.

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

• Sample Size: The document repeatedly states "All samples met the acceptance criteria" or "The samples are visually inspected..." or "All samples are performed/tested..." indicating that multiple samples were used for each test, but the exact number of samples for each specific test is not explicitly quantified (e.g., "n=X").
• Data Provenance: The data are from laboratory bench testing and biocompatibility testing. Given "ASAHI INTECC CO., LTD." is based in "Aichi, Japan," it's highly probable the testing was conducted prospectively at their R&D facilities or authorized contract labs, likely in Japan or globally recognized testing centers.

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

• N/A for this type of device. This device is a physical guidewire, not an AI or imaging device requiring expert interpretation for ground truth. "Ground truth" here refers to the measured physical and performance characteristics determined by established test methods and standards.

4. Adjudication Method for the Test Set:

• N/A. Adjudication methods like 2+1 or 3+1 are typical for subjective human assessments (e.g., in reading medical images) to establish a consensus ground truth. For objective physical device testing, results are typically quantitative measurements against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:

• N/A. This is a physical guidewire, not an AI-powered diagnostic or assistive tool for human readers. No human clinical performance study (like an MRMC) involving "human readers" or "AI assistance" was conducted as part of this 510(k) submission.

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

• N/A. This applies to AI algorithms. The performance of this guide wire was evaluated through bench testing against established physical and mechanical properties.

7. The Type of Ground Truth Used:

• For performance testing: Objective engineering measurements and observations against predetermined specifications and widely accepted industry standards (e.g., "All samples met the acceptance criteria" implying specific numerical or qualitative thresholds were achieved). The FDA guidance document "Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling," October 2019, served as a reference for the test methods, which implicitly defines the "ground truth" of what constitutes acceptable performance for such a device.
• For biocompatibility testing: Established laboratory test results compared against ISO 10993 series standards and control samples.

8. The Sample Size for the Training Set:

• N/A. This is not an AI/ML device that requires a training set. The "design" of the device is based on engineering principles and comparison to existing predicate devices, not data-driven machine learning.

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

• N/A. As above, no training set or ground truth in the context of an AI/ML model was established for this device.

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This product is intended to direct a catheter to the desired anatomical vasculature (excluding coronary and cerebral vessels).

The CROSSLOOP is steerable guide wire with a maximum diameter of 0.018 inches (0.46 mm) and available in various lengths of 200 cm, 235 cm and 300 cm. The CROSSLOOP consists of a stainless-steel (SUS) core wire with a Pt-Ni alloy coil, soldered with Au-Sn solder. The distal tip is loop-structured. The coil is radiopaque to achieve visibility and can be made to bend easily to accommodate vessel tortuosity. A silicone and hydrophilic coating are applied to the distal portion of the guide wire. A hydrophobic coating (PTFE) is applied to proximal portion. The purpose of these surface coatings is to provide lubricity when the guide wire is passed through percutaneous catheters.

The provided text describes a 510(k) premarket notification for a medical device called "CROSSLOOP," a catheter guide wire. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's absolute safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval Application).

Therefore, the information you're asking for, such as "acceptance criteria and the study that proves the device meets the acceptance criteria," "sample size for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how the ground truth for the training set was established," are not directly applicable or available in this document.

This 510(k) summary focuses on non-clinical testing/performance data and biocompatibility to demonstrate that the device is substantially equivalent to existing cleared devices, not that it independently proves clinical efficacy or diagnostic accuracy (as would be the case for an AI-powered diagnostic device, for example).

Here's how to address your points based on the provided text:

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

The document states: "The in vitro bench tests demonstrated the CROSSLOOP met all acceptance criteria and performed similarly to the predicate and reference devices." However, it does not provide a table specifying the precise acceptance criteria or quantitative performance results for each test. It only lists the types of non-clinical tests performed:

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

• Sample Size: Not specified for any of the non-clinical tests.
• Data Provenance: The tests are "in vitro bench tests" and "biocompatibility" tests. The manufacturer is ASAHI INTECC CO., LTD. whose global headquarters and R&D center are in Japan. The specific country where the testing was performed is not explicitly stated, but it's likely linked to the manufacturer's R&D facilities. These are laboratory tests, not clinical data, so terms like "retrospective" or "prospective" don't apply in the common clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this type of device and submission. "Ground truth" established by experts (like radiologists for imaging devices) is relevant for AI/ML-powered diagnostic tools or clinical studies, neither of which are described here. The "ground truth" for the non-clinical tests would be the established engineering and materials science standards and specifications.

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

This is not applicable. Adjudication methods are typically used in clinical trials involving human observation or interpretation, especially with imaging reads. For bench testing, results are typically quantitative measurements compared against predefined 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 is not applicable. An MRMC study is designed for AI-assisted diagnostic devices to assess the impact of AI on human reader performance. The "CROSSLOOP" is a physical medical device (catheter guide wire), not an AI/ML software tool.

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

This is not applicable. This question refers to the performance of an AI algorithm in isolation. The CROSSLOOP is a physical medical device.

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

For a physical device like a guide wire, the "ground truth" for non-clinical testing refers to pre-defined engineering specifications, material properties, and performance standards (e.g., tensile strength required to withstand certain forces, flexibility within a specified range, biocompatibility per ISO standards). This is not derived from expert consensus on clinical cases, pathology, or outcomes data, but rather from material science and mechanical engineering principles.

8. The sample size for the training set

This is not applicable. "Training set" refers to data used to train AI/ML models. This device is not an AI/ML product.

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

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

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This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. Do not use the guide wire in neurovascular.

The CROSSLEAD 0.014inch is steerable guide wire with a maximum diameter of 0.014inch (0.36mm) and available in various lengths of 100cm, 200cm, 235cm and 300cm. This quide wire consists of a hybrid nitinol (Ni-Ti) and stainless-steel (SUS) core wire with a stainless-steel inner coil and Platinum-Nickel (Pt-Ni) outer coil. The coil is radiopaque 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. A hydrophobic coating is applied to proximal portion. The basic structure, construction and materials of the CROSSLEAD 0.014inch are similar to those of previously described in the predicate ASAHI Gladius (K150445/K163426) and references; CROSSLEAD Penetration (K230377), MINAMO (K190176) and Astato XS40 (K153443/K163426).

All sizes are available with a straight and a pre-shaped design.

This document is a 510(k) Premarket Notification for a medical device (CROSSLEAD 0.014inch guide wire) and does not describe a study involving an AI/Machine Learning enabled device. Therefore, it does not contain the information requested in the prompt regarding acceptance criteria and performance studies for such devices, including details on test sets, expert ground truth, MRMC studies, or training sets.

The document discusses non-clinical bench testing to demonstrate substantial equivalence to predicate devices, but this is for a physical medical device, not an AI algorithm.

Therefore, I cannot fulfill the request as the provided text does not contain information related to AI/ML device testing and acceptance criteria.

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This product is designed to direct a catheter to the desired anatomical location in the peripheral vasculature during diagnostic or interventional procedures. Do not use the guide wire in neurovascular.

The CROSSLEAD Tracker is steerable quide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 100cm, 200cm, 235cm and 300cm length. This Guide Wire consists of a hybrid Ni-Ti and stainless-steel core wire with a Pt-Ni inner coil and Pt-Ni and stainless-steel outer coil is soldered to the core wire with Ag-Sn solder. The coil has radiopacity 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. A hydrophobic coating is applied to proximal portion. The basic structure, construction, and material of the CROSSLEAD Tracker are similar to that previously described in the predicate Regalia XS 1.0 (K083146/K163426) and reference devices MINAMO (K190176), ASAHI Gaia Next(K192599) and ASAHI Gladius (K150445/K163426).

The provided text is a 510(k) Summary for a medical device (CROSSLEAD Tracker, a guide wire) and does not contain information about a study proving the device meets acceptance criteria related to AI/ML performance or human reader improvement.

The document details non-clinical laboratory testing performed to demonstrate substantial equivalence to predicate and reference devices, focusing on physical and material properties of the guide wire. These tests are standard for medical devices and are not related to AI/ML or a comparative effectiveness study involving human readers.

Therefore, I cannot provide the requested table and information as it pertains to AI/ML performance and human reader studies because this information is not present in the provided document.

The "Non-clinical testing/performance data" section (Page 8) lists various physical tests:

• Tensile Strength
• Torque Strength
• Torqueability
• Tip Flexibility
• Coating Integrity
• Catheter Compatibility
• Visual Inspection
• Corrosion Resistance
• Kink Resistance
• Radio-Detectability
• Dimensional Verification
• Coating Integrity / Acute Particulate Characterization

And "Biocompatibility" tests:

• Cytotoxicity
• Sensitization
• Intracutaneous Irritation
• Systemic Toxicity
• USP Rabbit Pyrogen, Material Mediated
• Hemolysis
• Partial Thromboplastin Time
• In Vivo Thromboresistance
• Sc5b-9 Complement Activation

The document states: "The in vitro bench tests demonstrated the CROSSLEAD Tracker met all acceptance criteria and performed similarly to the predicate and reference devices." However, it does not provide the specific numerical acceptance criteria or the reported performance for each of these physical and biocompatibility tests. It also does not discuss any computational or AI-driven aspects, nor does it mention a study involving human readers, sample sizes for test/training sets, or expert ground truth establishment for such studies.

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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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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 VASSALLO GT 018 Peripheral Guide Wire in this submission is a steerable guide wire with a maximum diameter of 0.018" (0.45mm) and available in lengths of 190cm and 300cm. The device has a solid core with a hydrophilic coated coil-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. A detachable extension wire (hereafter "extension wire") is available to connect with the proximal end of the quide wire with a length of less than 300 cm. A Torque device is included in the same package.

The provided document describes the VASSALLO GT 018 Floppy peripheral guide wire. It does not describe an AI/ML powered device, but rather a medical device that facilitates the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. Therefore, many of the requested elements for AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this submission.

However, I can provide information based on the non-clinical testing performed for the device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The in vitro bench tests demonstrated that the VASSALLO GT 018 met all acceptance criteria and performed similarly to the predicate and reference devices." However, specific quantitative acceptance criteria and their corresponding reported device performance values are not detailed in this document. The document only lists the types of tests performed.

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

The document does not specify the sample sizes used for each non-clinical bench test. The data provenance is not explicitly stated in terms of country of origin for the testing, but the applicant company, FILMECC CO., LTD., is based in Japan. These would be considered prospective tests conducted specifically for this submission.

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

Not applicable. This is a medical device and the tests are non-clinical bench tests (e.g., tensile strength, corrosion resistance). "Ground truth" in the context of expert consensus is not relevant here; the tests have objective physical or chemical measurements.

4. Adjudication method for the test set

Not applicable, as this refers to expert review processes for complex diagnostic outputs, not physical device performance tests.

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 not an AI/ML diagnostic tool.

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

Not applicable. This device is not an AI/ML algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is established by standard engineering and biocompatibility testing protocols and specifications. For example, for "Tensile Strength," the ground truth would be a pre-defined range of acceptable tensile forces according to relevant standards for guide wires. For biocompatibility, the ground truth is the absence of cytotoxicity, irritation, etc., according to recognized international standards (e.g., ISO 10993).

8. The sample size for the training set

Not applicable. This device does not involve machine learning and therefore has no "training set."

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

Not applicable. There is no training set for this device.

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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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