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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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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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