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The Willow 18 Guidewire is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Like the predicate device, the Willow 18 Guidewire is a single-use product with a shapeable tip, used to gain intravascular access to facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro and peripheral diagnostic and interventional procedures. The wire can be torqued to facilitate navigation through the vasculature. The Willow 18 Guidewire comes in two stiffness profiles: Soft and Standard.

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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 basic structure of the CHIKAI Nexus petit consists of a hybrid tapered core wire in which Ni-Ti alloy and stainless steel (SUS) is conjoined via Ni-Ti pipe. The distal part of the core wire is surrounded by the Pt-Ni (platinum-nickel) coil, soldered with Au-Sn (gold-tin) alloy. For the proximal coil, the joint section is covered by a tube made of Ni-Ti alloy. Within the tube, the stainless steel and Ni-Ti core wires are connected with ASAHI's proprietary stainless-steel coil, soldered with Au-Sn alloy and silver.

In addition, coatings are applied on the surface of the device. The distal coil section is coated with a polyurethane coating. The hydrophilic coating is applied from the distal tip, on top of the polyurethane coating, to the proximal shaft.

The maximum nominal outer diameter of the CHIKAI Nexus petit is 0.33 mm (0.013"). The diameter is tapered towards the distal tip with the nominal diameter of 0.16mm (0.006"). The CHIKAI Nexus petit's radiopaque distal tip (up to 8cm from the tip) enables the user to view the position of the tip under X-ray fluoroscopy.

The device is available in length of 220cm with tip-shape variations of Straight, Round-curve and J-shape design.

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The 0.014" Willow Guidewire is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Like the predicate device, the 0.014" Willow Guidewire is a single-use product with a shapeable tip available in straight and pre-shaped configurations, used to gain intravascular access to facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro and peripheral diagnostic and interventional procedures. The wire can be torqued to facilitate navigation through the vasculature. The 0.014" Willow Guidewire comes in three stiffness profiles: Soft, Standard and Support.

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The X-Wire Guidewire is indicated for general intravascular use within the peripheral and neuro vasculature to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Imperative Care's X-Wire Guidewires are guidewires with shapeable tips to aid in accessing the peripheral and neuro vasculature. The guidewires are available in 200cm - 300cm lengths, standard (S) and support (T) stiffness profiles, and 0.014", 0.018" and 0.024" diameters. The distal portion of the guidewire tip includes a radiopaque marker to facilitate fluoroscopic visualization. A hydrophilic coating on the distal segment and PTFE coating on the proximal segment serve to reduce friction during manipulation in vessels. The X-Wire Guidewire is supplied with a shaping mandrel, introducer, and torque device.

This document is a 510(k) clearance letter for a medical device and therefore does not contain acceptance criteria and study data in the format typically found in clinical efficacy studies for AI/software devices. The acceptance criteria and "study" described herein relate to the safety and performance of the physical guidewire device (X-Wire Guidewire) based on bench testing, biocompatibility testing, sterilization validation, and shelf-life testing, rather than a clinical study evaluating the performance of an AI algorithm.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document summarizes the performance testing done in Table 2: Summary of Bench Tests and Performance Specifications and Table 3: Biocompatibility Test Summary – X-Wire Guidewire.

Table: Acceptance Criteria and Reported Device Performance (Synthesized from document)

Important Note: This document describes a physical medical device (guidewire), not a software/AI device. Therefore, many of the subsequent questions related to AI studies (test sets, ground truth, experts, MRMC studies, standalone performance, training sets) are not applicable to this 510(k) submission.

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

• Test Set Sample Size: Not explicitly stated as a number of "cases" or "patients" in the typical sense of a clinical study. The testing here refers to physical guidewire samples subjected to bench tests and biological evaluations. The specific number of devices tested for each attribute (e.g., number of guidewires for torqueability, number of animal subjects for biocompatibility) is not detailed in this summary, but would be found in the full test reports.
• Data Provenance: N/A for clinical data. The data is generated from laboratory (bench and biocompatibility) testing of the physical device.

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

• Number of Experts: Not applicable. Ground truth for the physical device performance (e.g., whether a guidewire kinks or corrodes) is established by objective measurements and standardized test protocols, not by expert consensus in a clinical diagnostic sense. However, for the biocompatibility testing, an "expert evaluation" is mentioned as confirming that the device met biological safety requirements. The number and qualifications of this expert(s) are not specified.

4. Adjudication Method (for the test set)

• Adjudication Method: Not applicable in the context of an AI study. For the bench and biocompatibility tests, "adjudication" would refer to the interpretation of raw test data against predefined acceptance criteria by qualified laboratory personnel, which is inherent in the "Pass" results reported.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

• MRMC Study: No. This is a physical guidewire device, not an AI or software device that would typically involve human reader performance evaluation.

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

• Standalone Performance: Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used

• Ground Truth Type:
  • Bench Testing: Objective physical measurements, engineering specifications, and performance defined by established standards (e.g., ability to transmit torque, resistance to kinking, coating integrity). Performance is compared against similar predicate devices and general industry standards.
  • Biocompatibility Testing: Established by standardized biological assays (e.g., ISO 10993 series) that measure cellular response, material-mediated effects, and systemic reactions in vitro/in vivo, compared to predefined safety thresholds.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is a physical device, not an AI or machine learning model that requires a training set.

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

• Training Set Ground Truth Establishment: Not applicable, as there is no training set for an AI model.

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The 0.014" Willow Guidewire is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Like the predicate device, the 0.014" Willow Guidewire is a single-use product with a shapeable tip available in straight and pre-shaped configurations, used to gain intravascular access to facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro and peripheral diagnostic and interventional procedures. The wire can be torqued to facilitate navigation through the vasculature. The 0.014" Willow Guidewire comes in three stiffness profiles: Soft, Standard and Support.

The provided FDA 510(k) clearance letter and summary for the 0.014" Willow Guidewire do not describe a study involving an AI/Machine Learning device.

Instead, this document describes a traditional medical device (a guidewire) and its clearance process through substantial equivalence to a legally marketed predicate device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biocompatibility bench testing, not clinical performance studies for an AI algorithm.

Therefore, many of the questions related to AI/ML device performance (like sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, effect size of AI assistance) are not applicable to this document.

However, I can extract the relevant information regarding the acceptance criteria and the engineering study (bench performance testing) for the 0.014" Willow Guidewire.

Acceptance Criteria and Study for the 0.014" Willow Guidewire

The 0.014" Willow Guidewire is a traditional medical device, not an AI/ML device. Therefore, the "acceptance criteria" and "study" refer to engineering specifications and bench performance testing, along with biocompatibility testing, to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by "Acceptance criteria were met" or "considered acceptable" for each test. The reported device performance is that these criteria were successfully achieved.

Information Not Applicable (NA) to this Device/Submission:

The following questions are specifically targeted at AI/ML medical devices and are not relevant to the 0.014" Willow Guidewire, which is a traditional physical medical device.

2. Sample size used for the test set and the data provenance: NA (This is a physical device, not an AI/ML algorithm requiring a data test set.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: NA (No "ground truth" in the AI/ML sense is established for this type of device.)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: NA (No adjudication method described for physical device testing.)
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: NA (No MRMC study or AI assistance involved.)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: NA (Not an algorithm.)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): NA (Ground truth is not a concept applied in this context; performance is measured against engineering specifications and predicate characteristics.)
8. The sample size for the training set: NA (No training set for a physical device.)
9. How the ground truth for the training set was established: NA (No training set or ground truth in this context.)

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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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The Aristotle 14 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Aristotle 18 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Aristotle 24 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Zoom Wire 14 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Aristotle Colossus Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional devices. The guidewire is not intended for use in the coronary vasculature.

The Scientia Vascular's Aristotle 14, Aristotle 18, Aristotle 24, Zoom Wire 14, and Aristotle Colossus Guidewires ("the guidewires") are steerable guidewires with a shapeable tip to aid in accessing the neuro and peripheral vasculatures. The guidewires are supplied sterile, for single use only.

The distal portion of each guidewire's tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. All guidewires have a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels.

The guidewires are provided with an accessory kit consisting of an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve), a torque device (to attach to the proximal portion of the guidewire to facilitate gripping and manipulation of the guidewire during use), and a shaping mandrel (to aid in shaping the flexible tip of the guidewire). These accessory devices are included to facilitate use of the guidewires and are not intended to contact the patient's body.

This document describes a 510(k) clearance for several guidewire devices, not an AI/ML medical device. Therefore, the information requested about acceptance criteria and studies related to AI/ML device performance (such as sample sizes for test/training sets, expert ground truth establishment, MRMC studies, etc.) is not applicable and cannot be extracted from this document.

The document primarily focuses on establishing substantial equivalence for physical medical devices—guidewires—by comparing their technological characteristics and performing non-clinical performance tests (biocompatibility, sterilization, bench performance).

Here's a breakdown of why this document does not contain the requested information about an AI/ML device:

• Device Type: The clearance is for "Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire" which are physical catheter guide wires. These are traditional medical devices, not software or AI/ML devices.
• Study Types: The studies described are "Biocompatibility," "Sterilization," and "Bench Performance Testing" (Visual Inspection, Coating Integrity, Corrosion Resistance, Agent Compatibility, Simulated Use, Particulate). These are mechanical and biological tests relevant to physical devices, not algorithmic performance.
• Missing Information: All points you requested regarding AI/ML performance are absent because they are not relevant to this type of device clearance:
  • No acceptance criteria for AI performance metrics (e.g., sensitivity, specificity, AUC).
  • No test or training set sample sizes for AI data.
  • No information about experts establishing ground truth for images or data used by an AI.
  • No adjudication methods.
  • No MRMC comparative effectiveness studies.
  • No standalone algorithm performance.
  • No ground truth type related to AI (e.g., imaging labels, pathology).

The document explicitly states:

• "No animal testing was deemed necessary to support the substantial equivalence of the subject devices."
• "No clinical testing was deemed necessary to support the substantial equivalence of the subject devices."

This indicates that the clearance relies on non-clinical data and comparison to predicate devices, which is common for guidewires, especially when the changes are minor (like a different PTFE coating).

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Synxess Neurovascular Guidewire 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 guidewire is intended for use only in the neuro vasculature.

The Synxess Neurovascular Guidewire is available in diameters of 0.014 inch (0.35 mm) and 0.010 inch (0.25 mm) and has 200 cm length. The device is comprised of a core wire, coils, and coatings, and is supplied with a shaping mandrel and a torque device. The guidewire distal tip is straight and shapeable. The device is provided sterile and is for single use.

The provided text describes a 510(k) premarket notification for a medical device, the Synxess Neurovascular Guidewire, and details the non-clinical testing performed to establish substantial equivalence to predicate devices. It does not describe an AI/ML-driven device or a study involving human readers and AI assistance. Therefore, many of the requested points in the prompt (e.g., AI performance metrics, MRMC study, expert ground truth establishment for AI, training set details) are not applicable to this document.

However, I can provide information based on the provided text regarding the device's acceptance criteria and the study that proves it meets them, focusing on the non-clinical performance testing conducted for a guidewire.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance for Synxess Neurovascular Guidewire

The acceptance criteria for this non-AI device are based on passing various performance bench tests and biocompatibility tests in accordance with relevant international standards and FDA guidance. The study proving the device meets these criteria is the battery of non-clinical tests performed.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test are implicitly "Pass" or "Met acceptance criteria" as defined by the referenced standards and guidance documents. The reported device performance for all listed tests was successful.

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of guidewires) used for each individual performance bench test or biocompatibility test. It only states that the device "passed all performance bench testing." For biocompatibility, some tests specify animal models (e.g., guinea pig, rabbits, mice, dogs), but the specific number of animals is not provided.
• Data Provenance: The document generally indicates that the tests were performed in accordance with "internal requirements, referenced guidance and international standards." The country of origin for the data is implied to be from the manufacturer, Enlight Medical Technologies (Shenzhen) Co., Ltd., located in China. The data would be considered prospective as it was generated specifically for this 510(k) submission.

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

• This question is not applicable as this is a physical medical device (guidewire), not an AI/ML-driven diagnostic device requiring expert clinical interpretation for ground truth. The "ground truth" for these tests is defined by the physical and chemical properties measured against established engineering and biological standards.

4. Adjudication Method for the Test Set

• This question is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human interpretation of medical images or patient data requires consensus, which is not relevant here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study was not performed because this is a physical medical device, not an AI/ML-driven system that assists human readers in diagnostic tasks. The document explicitly states: "No clinical testing was deemed necessary to support the substantial equivalence of the subject device."

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

• Not applicable. This is not an algorithm-only device.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established by engineering standards (e.g., measurements of tensile strength, torqueability, flexibility, dimensions) and biological/chemical standards for biocompatibility (e.g., cytotoxicity assays, pyrogen tests, hemolysis assays). These are objective, quantifiable measures against predefined acceptance criteria from international standards (e.g., ISO 11070, ISO 10993 series) and FDA guidance.

8. The Sample Size for the Training Set

• Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

• Not applicable. This is a physical device, not an AI/ML model.

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