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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)

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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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The Drivewire 24 Guidewire is intended for general intravascular use, including the neuro and peripheral vasculature. The Drivewire 24 Guidewire is intended to facilitate the selective placement of diagnostic catheters. This device is not intended for use in the coronary arteries.

The Drivewire 24 Guidewire is a 0.024" diameter steerable guidewire with a deflectable tip to aid in accessing vasculature. The guidewire is supplied sterile (ETO sterilization) and is for single use only. The Drivewire 24 Guidewire is comprised of a stainless steel hypotube that is cut along its length to provide flexibility and tip deflection ability through control of the handle, an inner Nitinol braided flexible coil, an inner core wire, and a handle. The inner core wire runs inside the hypotube from the distal end to the handle. The distal end of the inner core wire is flattened, looped around and joined to the tip of the distal section of the hypotube, forming a deflectable tip. The hypotube is marked with fluoro-safe markers to provide visual clues to the user to initiate fluoroscopy guided insertion. In order to actuate the tip deflection in two directions, the Drivewire 24 Guidewire handle contains a tube assembly section. The handle is assembled to the proximal end of the core wire and controls the movement of the distal tip by pulling/pushing the inner moveable core wire, allowing the bending of the distal tip in two directions. The handle assembly has neutral landmarks to identify the location where the tip is straight. The Drivewire 24 Guidewire has a hydrophilic coating on its distal segment in order to reduce the friction of the guidewire while navigating. The Drivewire 24 Guidewire is provided with a torque accessory to facilitate use of the guidewire and is not intended to have patient contact.

The information provided does not describe an AI/ML device but rather a medical guidewire. As such, the typical acceptance criteria and study designs for AI/ML devices (e.g., test sets, ground truth, expert adjudication, MRMC studies, standalone performance, training sets) are not applicable here.

This document, K233791, is a 510(k) premarket notification for the Drivewire 24 Guidewire, a physical medical device. The submission demonstrates substantial equivalence to a predicate device (Aristotle 24 Guidewire) through non-clinical testing.

Here's an analysis of the provided information, framed to address the prompt's questions where applicable, but explicitly noting the absence of AI/ML-specific details:

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

The document provides a table of "Non-Clinical Testing" which outlines various bench tests, their methods, and results indicating they met acceptance criteria. While specific numerical acceptance criteria are not always stated, the results confirm successful performance.

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

• Bench Tests: The specific number of devices tested for each bench test is not explicitly stated, but the results refer to "All devices," implying a sufficient sample was used to statistically validate the findings against acceptance criteria. Data provenance for bench tests is typically from the manufacturer's internal labs.
• Biocompatibility Tests: The description mentions "test article extract" or "test articles," indicating samples of the device or its materials were used according to ISO 10993 standards.
• Animal Study: The study was conducted in "domestic swine." The number of animals or devices used per animal is not specified but is implicitly sufficient for a GLP study.

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 question is not applicable as this is a physical medical device, not an AI/ML diagnostic system requiring expert ground truth for interpretation. The "Usability Evaluation" mentioned that "Physicians evaluated the guidewire in clinically relevant simulated use models," implying expert input, but details on their number or qualifications are not provided.

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

Not applicable, as this is not an AI/ML diagnostic study requiring expert adjudication of results.

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. No MRMC study was performed as this is a physical medical device. The efficacy is demonstrated through non-clinical testing and comparison to a predicate device.

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

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

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

For a physical device like a guidewire, the "ground truth" is established through physical and material science measurements, functional performance testing against defined engineering specifications, and biological safety testing against established international standards (e.g., ISO 10993). In the animal study, the "ground truth" for thrombogenicity was the direct examination of devices, renal arteries, and downstream organs for thrombus absence.

8. The sample size for the training set

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

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

Not applicable. No training set for an AI/ML model was involved.

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The Aristotle 18 Guidewire is intended for general vascular use within the neuro and peripheral vasculatures to introduce and position catheters and other interventional device 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 Scientia Vascular's Aristotle 18 Guidewire and Aristotle 24 Guidewire 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, in the following diameters, stiffness profiles, and lengths:

Aristotle 18 Guidewire
Diameter: 0.018"
Stiffness Profiles: Soft, Standard, Support
Length: 200 cm, 300 cm

Aristotle 24 Guidewire
Diameter: 0.024"
Stiffness Profiles: Soft, Standard, Support
Length: 200 cm, 300 cm

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.

The provided text is a 510(k) summary for the Aristotle 18 Guidewire and Aristotle 24 Guidewire. This type of submission to the FDA focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria through a full clinical study with a defined test set and ground truth.

Therefore, many of the requested details about acceptance criteria, test set, expert adjudication, MRMC studies, standalone performance, and ground truth establishment (which are typical for AI/ML device clearances or more complex clinical effectiveness studies) are not applicable to this 510(k) submission.

This submission relies on:

1. Similarities in indications for use, intended use, operating principles, design, materials, packaging, and sterilization processes to predicate devices.
2. Bench testing data from predicate/reference devices to support the performance of the new models, particularly noting that the added length (100 cm) is at the proximal end and does not impact the distal end's features or dimensions.
3. Biocompatibility and sterilization data from reference devices which are deemed applicable due to material and process commonality.
4. A risk assessment (ISO 14971) concluding that no new questions of safety or effectiveness are raised and no additional testing is necessary.

Since this is a guidewire, the "performance" typically refers to physical characteristics rather than diagnostic accuracy like an AI/ML product.

Here's a breakdown based on the information provided, highlighting what is and is not present:

1. Table of acceptance criteria and the reported device performance

No explicit acceptance criteria table is provided as this is a substantial equivalence claim, not a de novo or PMA where specific performance targets might be set and then measured against. The "performance" is implicitly demonstrated through the similarity to predicate devices and the lack of new safety/effectiveness concerns due to the minor modification (increased length at the proximal end).

The document states:

• "The subject devices have the following similarities to the previously cleared predicate devices:
  • The same indications for use,
  • The same intended use,
  • The same operating principle,
  • The same basic guidewire design,
  • The same materials, and
  • The same packaging materials and sterilization processes."
• "The bench performance testing conducted for the reference devices (K222347, K173235) and the predicate 200 cm long models of the subject guidewires cleared under K183608 and K192783, support the performance of the subject devices (300 cm) because they use the same materials, processes, components, and dimensions within the range of the previously cleared predicate and reference devices."
• "Following the risk assessments conducted in accordance with ISO 14971, no additional testing was deemed necessary to support the substantial equivalence of the subject device models."

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

• No specific "test set" in the context of an AI/ML model for diagnostic accuracy is described. The studies referenced are bench performance testing, biocompatibility, and sterilization, which are standard for guidewire manufacturing and safety.
• The provenance of data for the bench testing and biocompatibility is not explicitly stated (e.g., country of origin) but would typically be from the manufacturer's internal testing.
• The studies were retrospective in the sense that they relied on pre-existing data from predicate and reference devices (K222347, K173235, K183608, K192783) and did not generate new clinical data for this specific submission.

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

• Not applicable. This submission does not involve diagnostic interpretation or human reader performance, so there's no "ground truth" establishment by experts in the sense of image annotation or disease diagnosis. The "ground truth" for guidewire performance comes from engineering specifications and bench testing.

4. Adjudication method for the test set

• Not applicable. No human adjudication of results is mentioned or required for this type of device and submission.

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 guidewire, a physical medical instrument, not an AI/ML diagnostic or image-assisted tool for human readers. No MRMC study was performed.

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

• Not applicable. This device is a guidewire, not an algorithm.

7. The type of ground truth used

• For the performance assessment, the "ground truth" for the guidewire's characteristics (e.g., diameter, stiffness, coating, radiopacity) is based on engineering specifications, material science properties, and established bench testing methods to ensure the physical device meets its design intent and functions as expected within the vasculature. This is not a "ground truth" in terms of disease presence or absence like in diagnostic studies.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set" or corresponding ground truth to establish for this type of device.

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SmartGUIDE guidewire is intended for general intravascular and peripheral vascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. SmartGUIDE is intended to be used only by physicians trained in percutaneous, intravascular techniques and procedures.

SmartGUIDE is a deflectable quidewire 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 neurovasculature. The device is available with a nominal outer diameter of 0.014" (0.36 mm) and overall length of 200 cm. The device is available sterile and is for single use only.

The provided text describes the SmartGUIDE deflectable hydrophilic guidewire (K222690), a medical device, and its substantial equivalence to a predicate device. It details various tests conducted to demonstrate its safety and effectiveness, but it does not pertain to an Artificial Intelligence (AI) or machine learning device.

Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test sets and training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training) are not applicable to this document.

However, I can extract and present the acceptance criteria and performance data for the physical medical device as described in the provided text.

Here is the information based on the provided document:

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

For the SmartGUIDE deflectable hydrophilic guidewire, the acceptance criteria are generally implied by conformity to established standards and guidance documents (e.g., FDA Guidewire Guidance, ISO 11070) and comparative equivalence to a predicate device. The "reported device performance" is consistently "Pass" or "Pass / Equivalent," indicating that the device met these criteria.

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

• This document describes a non-AI/ML medical device.
• Sample Size (Pre-Clinical Animal Study): Not explicitly stated, but it was a "controlled good laboratory practice (GLP) study in domestic swine." The number of animals used is not specified.
• Data Provenance: The pre-clinical animal study was conducted as a "controlled good laboratory practice (GLP) study in domestic swine." No country of origin is listed for the study data. It is a prospective study in animals.
• For bench and biocompatibility testing, sample sizes are also not explicitly stated, but these are standard laboratory tests.

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)

• Not applicable as this is not an AI/ML device study requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for the device's performance comes from validated laboratory tests and the observation of physical and physiological responses in animal studies.

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

• Not applicable as this is not an AI/ML device study involving human interpretation with adjudication. The assessment of device performance in bench and animal studies relies on established measurement protocols and scientific observation.

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 as this is not an AI/ML device. No MRMC study was performed.

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

• Not applicable as this is not an AI/ML device.

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

• For bench testing: Established physical and mechanical measurement standards and validated laboratory protocols (e.g., measuring forces, observing fractures, checking coating integrity).
• For biocompatibility: Standardized in vitro and in vivo toxicology tests (e.g., cytotoxicity, sensitization, hemolysis) with predefined acceptance criteria as per ISO 10993.
• For pre-clinical animal testing: Direct physiological observation, macroscopic and microscopic evaluation of tissues and organs (pathology), and assessment of device functionality and complications in vivo.

8. The sample size for the training set

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML 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 Volo 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 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 Scientia Vascular's Aristotle 14, Aristotle 24, Volo 14, and Zoom Wire 14 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, in the following diameters, stiffness profiles, and lengths:

Aristotle 14 Guidewire: Diameter 0.014", Stiffness Profiles Soft, Standard, Lengths 200 cm, 300 cm
Aristotle 18 Guidewire: Diameter 0.018", Stiffness Profiles Soft, Standard, Support, Length 200 cm
Aristotle 24 Guidewire: Diameter 0.024", Stiffness Profiles Soft, Standard, Support, Length 200 cm
Volo 14 Guidewire: Diameter 0.014", Stiffness Profiles Soft, Standard, Lengths 200 cm, 300 cm
Zoom Wire 14 Guidewire: Diameter 0.014", Stiffness Profiles Support, Extra Support, Lengths 200 cm, 300 cm

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 concerns the 510(k) premarket notification for five guidewires: Aristotle 14 Guidewire, Aristotle 18 Guidewire, Aristotle 24 Guidewire, Volo 14 Guidewire, and Zoom Wire 14 Guidewire. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

1. Acceptance Criteria and Reported Device Performance:

The acceptance criteria are not explicitly stated as numerical thresholds for performance metrics. Instead, the document indicates that the devices "met acceptance criteria" or "passed" various tests, implying successful adherence to pre-defined standards for each test. The study's focus is on demonstrating similar performance and safety to predicate devices, particularly given a change in the PTFE coating.

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

• Test Set Sample Size: The document does not explicitly state the numerical sample sizes for each specific test (e.g., number of guidewires tested for coating integrity). It only mentions that "performance testing was performed on the subject devices" and "testing and evaluation... of the subject devices has been performed".
• Data Provenance: The data provenance is internal to the manufacturer (Scientia Vascular, Inc.) and is prospective testing conducted specifically for this 510(k) submission. There is no mention of country of origin for the data other than it being part of an FDA submission from a U.S.-based company.

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

• This submission pertains to a medical device's physical and biological performance, not an AI/software device that requires expert-established ground truth for diagnostic or interpretative tasks. Therefore, these details are not applicable. The "ground truth" for the tests mentioned (biocompatibility, sterilization, bench performance) is based on established, standardized test methods (e.g., ISO standards, FDA guidance documents).

4. Adjudication method for the test set:

• Not applicable, as this is not a diagnostic AI/software study involving human interpretation that requires adjudication of expert opinions. The performance is assessed against objective technical specifications and standards.

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 not an AI/software device that involves human readers or an AI assistance component.

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

• Not applicable. This is a hardware medical device (guidewire) and does not involve an algorithm or AI.

7. The type of ground truth used:

• The "ground truth" for the various tests conducted is based on:
  • Standardized Test Methods: Adherence to defined protocols from ISO 10993 series, ISO 14971:2019, ISO 11070:2014, and FDA guidance documents.
  • Objective Measurements: E.g., cell culture observations for cytotoxicity, temperature rise for pyrogenicity, measurement of physical dimensions, observation of material integrity.
  • "Pass/Fail" Criteria: Compliance with established thresholds or qualitative assessments as defined by the standard test methods (e.g., "Non-cytotoxic," "Non-hemolytic," "Acceptance criteria met").

8. The sample size for the training set:

• Not applicable. As this is not an AI/software device, there is no "training set" in the context of machine learning.

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

• Not applicable, as there is no training set for an AI/software algorithm.

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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.

Scientia Vascular's Aristotle Colossus Guidewire is a modification of Scientia Vascular's Aristotle 24 Guidewire. It is a 0.035" diameter, steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided in a single stiffness profile (standard) and is available in a range of lengths from 150 cm to 300 cm. The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in tortuous vessels.

The guidewire is provided with a shaping mandrel, an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a rotating hemostasis valve (RHV)), and a torque device (to attach to the proximal portion of the guidewire to facilitate gripping and manipulation of the guidewire during use). The shaping mandrel, introducer, and torque device accessories are included to facilitate use of the guidewire and are not intended to contact the patient's body.

The provided text describes a medical device, the Aristotle Colossus Guidewire, and its clearance process with the FDA. It details a comparison to a predicate device and reports on non-clinical performance tests. However, the document does NOT contain information about any study involving human readers, AI assistance, or the establishment of ground truth by experts for such a study. It specifically focuses on the physical and functional characteristics of a guidewire.

Therefore, I cannot provide the detailed information requested regarding acceptance criteria and studies that prove the device meets those criteria in the context of an AI/human-in-the-loop performance evaluation. The document describes a traditional medical device clearance process based on material properties, functional performance, and biocompatibility.

Here's a breakdown of why I cannot fulfill your request based on the provided text, and what is present:

Information NOT present in the document which your request asks for:

• A table of acceptance criteria and reported device performance related to AI/human reader performance.
• Sample size used for a test set in the context of AI/human reader performance.
• Data provenance (country of origin, retrospective/prospective) for AI/human reader performance data.
• Number of experts used to establish ground truth for an AI/human reader test set or their qualifications.
• Adjudication method for an AI/human reader test set.
• Results of a multi-reader multi-case (MRMC) comparative effectiveness study (effect size of human readers with/without AI).
• Results of a standalone (algorithm only) performance study.
• Type of ground truth used (expert consensus, pathology, outcomes data) in the context of AI interpretation.
• Sample size for a training set (for an AI model).
• How ground truth for a training set was established (for an AI model).

Information that IS present in the document (but is for a physical medical device, not an AI/Software as a Medical Device):

The document describes the acceptance criteria and performance study for the Aristotle Colossus Guidewire, which is a physical medical device (a guidewire for vascular procedures). The studies described are non-clinical (laboratory and simulated use) to demonstrate the device's physical and biological safety and effectiveness.

1. Acceptance criteria and reported device performance (for the physical guidewire):

The document states: "Results of tests performed on the Aristotle Colossus Guidewire demonstrate that it met the test acceptance criteria and meets the requirements of relevant standards and FDA guidance documents."

The "Table 3: Summary of Subject Device Functional Testing" lists the tests performed and consistently reports: "The Aristotle Colossus Guidewires met test acceptance criteria."

Here's a summary of the stated "acceptance criteria" through the lens of successful test outcomes for the physical guidewire:

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

• Sample Size: Not specified quantitatively for each test, but it refers to the physical guidewires tested. Standard engineering and biocompatibility testing typically involves a specific number of units per lot or batch, but these numbers are not detailed in this summary.
• Data Provenance: The studies are non-clinical performance tests conducted in a laboratory setting, likely by or for the manufacturer, Scientia Vascular, Inc. (West Valley City, Utah). They are simulations or bench tests rather than data derived from patients. The studies are prospective in the sense that they were designed and executed to evaluate this specific device for regulatory submission.

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 in the context of this device's testing. The "Usability Evaluation" involved "Physicians [who] evaluated subject and predicate guidewires for various performance characteristics in a human cadaver." The number and specific qualifications of these physicians are not provided. This is a usability assessment, not an expert panel for establishing ground truth for diagnostic accuracy.

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

Not applicable. This is for a physical device, and the "usability evaluation" doesn't describe a ground truth adjudication process in the manner seen for diagnostic AI.

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 guidewire, not an AI diagnostic tool.

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

Not applicable. This device is a guidewire, not an AI algorithm.

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

The "ground truth" for this device's performance is established by engineering specifications, material science standards, and in vitro/ex vivo (cadaver) performance. For biocompatibility, it's established via standardized biological assays. There is no "ground truth" in the clinical diagnostic sense with expert consensus or pathology involved.

8. The sample size for the training set:

Not applicable. This device does not use a "training set" in the context of machine learning or AI.

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

Not applicable.

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