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The Synchro SELECT Guidewire series 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 neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Like the primary Predicate device, the Synchro SELECT 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 Synchro SELECT Guidewire comes in three stiffness profiles: Soft, Standard, and Support.

The provided text describes the regulatory submission for a medical device (Synchro SELECT Guidewire) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing the kind of detailed performance study data against acceptance criteria that would typically be seen for a novel AI/ML-based device.

Therefore, the information required to answer your specific questions about "acceptance criteria and the study that proves the device meets the acceptance criteria" for an AI/ML device (e.g., sample size, expert ground truth, MRMC study, standalone performance, training set details) is not present in the provided document.

This document pertains to a physical medical device (guidewire) and its bench testing to establish equivalency to existing devices. The "acceptance criteria" here refer to standard engineering and material performance specifications for a guidewire, not performance metrics of an AI algorithm.

However, I can extract the acceptance criteria and performance data for the physical device based on the provided "Testing Summary" table (Table 2).

Acceptance Criteria and Reported Device Performance (Physical Device)

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

Since this is a physical medical device, the "acceptance criteria" are implied by the test methods and the "Conclusions" represent the reported performance as meeting those criteria.

Regarding the specific questions tailored for AI/ML devices:

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

• Not applicable / Not provided. The document describes "bench testing" of physical prototypes, not data-driven AI/ML model testing. There is no mention of "data provenance" in the context of patient data for model evaluation.

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 / Not provided. Ground truth, in the AI/ML sense, is not relevant for this physical device testing. The "ground truth" for these tests would be the established engineering specifications and measurement methodologies.

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

• Not applicable / Not provided. This concept is for clinical or human reader studies, not bench testing of a guidewire.

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

• No. The document explicitly states: "No animal or clinical studies were conducted as there is no change to the indications for use or the fundamental scientific technology." Therefore, no MRMC study was performed.

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

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

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

• Not applicable / Not provided. The ground truth for this device is based on engineering specifications, physical measurements, and comparison to predicate devices, as well as adherence to relevant ISO standards.

8. The sample size for the training set

• Not applicable / Not provided. There is no "training set" as this is not an AI/ML device. The testing described is for physical device verification.

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

• Not applicable / Not provided. Consistent with point 8, there is no training set for this type of device.

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The Synchro? Guidewire series 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 neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Like the primary predicate device, the Synchro2 Support Guidewire is a single-use product with a shapeable tip in straight and pre-shape configurations used to gain intravascular access to and 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.

This document describes the testing performed for the Stryker Neurovascular Synchro2 Support Guidewire (K190843) to demonstrate its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes used for each of the confirmatory tests (Tip Stiffness, Fracture, Tip Integrity, Particulate characterization, Coating integrity). The tests are described as "confirmatory testing."

The data provenance is not explicitly stated in terms of country of origin, nor is it specified whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a medical device modification, these are likely laboratory-based, in-vitro performance tests conducted by the manufacturer (Stryker Neurovascular) in a controlled environment.

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

This type of submission (510(k) for a guidewire) relies on engineering and material performance testing rather than clinical expert evaluation of images or patient data to establish ground truth. Therefore, the concept of "experts" as in radiologists or physicians establishing ground truth for a test set is not applicable here. The ground truth for these tests is based on established engineering and material science principles, industry standards, and the performance of the predicate device.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or subjective interpretation where adjudication would be necessary. The tests are objective, quantifiable measurements of physical properties.

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

No, an MRMC comparative effectiveness study was not explicitly mentioned or presented in the provided document. This type of study is typically associated with AI/CAD devices or diagnostic tools where human interpretation plays a significant role. The submission is for a physical medical device (guidewire) and focuses on engineering equivalence.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Not applicable. There is no algorithm or AI component in this device. The testing focuses on the physical performance of the guidewire itself.

7. The Type of Ground Truth Used

The ground truth used for the performance testing is based on:

• Established engineering specifications and design requirements: Each test would have a defined pass/fail criterion based on the device's intended function and safety.
• Performance of the Primary Predicate Device (K053268): The goal is to demonstrate that the modified device performs "as well as" the predicate device. Performance standards are likely derived from the predicate's known characteristics and regulatory clearance.
• Relevant industry standards: Such as ISO standards mentioned for biocompatibility (EN ISO 10993-1:2009) and sterilization (EN ISO 11135: 2014/AC: 2014).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device. The testing describes verification and validation of a physical medical device.

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

Not applicable, as there is no training set.

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The Direxion and Direxion HI-FLO Torqueable Microcatheters are intended for peripheral vascular use. The pre-loaded Fathom and Transend Guidewires can be used to selectively introduce and position the microcatheter in the peripheral vasculature. The microcatheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vessel.

The Direxion Microcatheter is available in small and large lumens. The Direxion Torqueable Microcatheter (Direxion) is a small lumen microcatheter with a distal outside diameter of 2.5F (0.85 mm), and a maximum outside diameter of 2.7F (0.95 mm). It has an inside diameter of 0.021 in (0.5 mm) minimally in the proximal and distal regions. The microcatheter lumen is able to accommodate steerable guidewires with diameters ≤ 0.018 in (0.47 mm).

The Direxion HI-FLO Torqueable Microcatheter (Direxion HI-FLO) is a large lumen microcatheter with a distal outside diameter of 2.9F (1.00 mm), and a maximum outside diameter of 3F (1.05 mm). It has an inside diameter of 0.027 in (0.6 mm) minimally in the proximal and distal regions. The microcatheter lumen is able to accommodate steerable guidewires with diameters ≤ 0.021 in (0.53 mm).

The Direxion and Direxion HI-FLO Microcatheters are available in a variety of tip shapes (Straight, Bern, Swan Neck, and J Shape) to aid with accessing challenging anatomy. The distal outer surface of the microcatheter is coated with a hydrophilic coating. A radiopaque marker is located at the distal tip to facilitate fluoroscopic visualization. Some Direxion Microcatheters have a second marker 3 cm proximal to the first marker. The distal tip of the microcatheter is steam shapeable. The proximal end incorporates a standard luer with rotating hemostatic valve (RHV) or Y-adapter.

The Direxion and Direxion HI-FLO Microcatheters are available with the following preloaded guidewires:

Fathom-16 Steerable Guidewire (K111485)

• 0.016 in (0.41 mm) diameter; 140 or 180 cm lengths

Transend 14/18 Steerable Guidewires (K971254 / K964611)

• 0.014 in (0.37 mm) or 0.018 in (0.47 mm) diameters; 135, 165 or 190 cm lengths

The guidewires have a hydrophilic coating to provide lubricity, which aids in the navigation of distal, tortuous vasculature. The guidewires are radiopaque to allow for visualization under fluoroscopy and the tips are shapeable.

Accessories may include a RHV or Y-adapter, steam shaping mandrel, microcatheter introducer, quidewire introducer and torque device.

The provided text describes a 510(k) premarket notification for microcatheters. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical or AI-centric studies. Therefore, many of the requested categories (e.g., effect size of human readers with AI assistance, algorithm-only performance, training set size, ground truth for training set) are not applicable to this document.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "bench testing was conducted for design elements and performance characteristics." However, it does not specify sample sizes for these tests, nor does it refer to a "test set" in the context of patient data or algorithm evaluation. Data provenance (e.g., country of origin, retrospective/prospective) is not applicable as this concerns bench testing of the physical device.

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

Not applicable. "Ground truth" in this context would refer to a benchmark for a diagnostic or AI device. This submission is for a physical medical device (microcatheter) where performance is evaluated through engineering and biocompatibility testing.

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

Not applicable. This concept belongs to studies where human experts or algorithms are evaluating data, typically for diagnostic accuracy.

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 microcatheter, not an AI-assisted diagnostic or treatment system.

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

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

7. The type of ground truth used

For the performance data listed, the "ground truth" is established through industry standards, engineering specifications, and validated test methods for material properties, functional performance (e.g., ID/OD dimensions, tensile strength, kink resistance, infusion pressure), compatibility, and biological safety.

8. The sample size for the training set

Not applicable. This device is a microcatheter, not an AI algorithm requiring a training set.

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

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

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