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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, and J) 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

• 0.016 in (0.41 mm) diameter; 140 or 180 cm lengths
  Transend 14/18 Steerable Guidewires
• 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.

This document is a 510(k) summary for the Direxion and Direxion HI-FLO Torqueable Microcatheters. It describes the device, its intended use, and performance data used to demonstrate substantial equivalence to a predicate device. However, it does not contain a study that proves the device meets specific acceptance criteria in the way typically expected for a medical device efficacy or performance study with quantified clinical outcomes or statistical analysis.

Instead, this document outlines an equivalence claim based on engineering and performance testing against predetermined acceptance criteria to show that modifications do not introduce new safety or performance issues compared to a legally marketed predicate device.

Here's an analysis based on the provided text, addressing your questions where possible:

Acceptance Criteria and Device Performance Study (as presented in this document)

The document lists various performance characteristics for which testing was conducted. It states that "The Direxion Microcatheters met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device." However, it does not provide a table with specific acceptance criteria values or detailed reported device performance values. It only states that the criteria were met.

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

A table cannot be fully constructed from the provided text as specific numerical acceptance criteria and reported performance values are not detailed. The document only lists the categories of tests performed and a general statement that the device "met the predetermined acceptance criteria."

Implicit acceptance criteria categories based on the text:

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

• Sample Size: The document does not specify the sample sizes used for any of the performance tests.
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. These are typically engineering tests performed in a lab setting, not clinical studies.

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

This information is not applicable to the type of testing described. The "ground truth" for these engineering and performance tests would be based on design specifications, industry standards, and predicate device characteristics, not expert clinical interpretation.

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

This information is not applicable to the type of testing described (engineering/performance tests). Adjudication methods are typically used in clinical studies involving interpretation of data by multiple human experts.

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

An MRMC comparative effectiveness study was not done. This document is for a medical device (microcatheter), not an AI/software device. Therefore, the concept of human readers improving with or without AI assistance is not relevant here.

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

This information is not applicable. The device is a physical microcatheter, not an algorithm or AI system.

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

As mentioned, the "ground truth" for these engineering and performance tests would be based on design specifications, industry standards, and equivalence to the predicate device's established performance. It is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is a physical medical device, not an AI or machine learning model.

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

This information is not applicable for the same reasons as #8.

In summary: This 510(k) document demonstrates substantial equivalence through a series of engineering and performance tests against predetermined acceptance criteria (which are not specifically detailed in the provided text). It is not a clinical study or an AI/MML device submission, so many of the requested categories (expert ground truth, sample sizes for training/test sets, MRMC studies) are not pertinent to this type of regulatory submission. The key takeaway is that the device met internal performance specifications designed to ensure it is as safe and effective as its predicate.

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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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