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The Headway Duo Microcatheter is intended for general intravascular use, including the peripheral and coronary vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials.

The Headway Duo Microcatheter is intended for neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic agents that have been cleared or approved for use in the neurovasculature and are compatible with the inner diameter of the Headway Duo Microcatheter.

The Headway Duo Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximalsection transitions to a flexible distal tip to facilitate advancement through vessels. Dual racionali markers at the distal end facilitate fluoroscopic visualization. The outer surface f the microcatheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the microcatheter hub is used for the attachment of accessories.

This document describes the Headway Duo Microcatheter, a medical device. The information provided is for regulatory clearance and focuses on engineering and biocompatibility testing, not on clinical performance or AI-related metrics. Therefore, it does not contain the specific information requested in many of the categories you've outlined, which are typically relevant to AI/ML software as a medical device (SaMD) or diagnostic imaging performance studies.

Here's a breakdown of the available information based on your request:

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

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

This document describes bench testing, not clinical studies with human subjects. Therefore, the concept of "test set" and "data provenance" in the context of patient data does not apply here. The "samples" would refer to the number of microcatheters or components tested for each bench test. The specific number of devices/samples tested for each individual bench test (e.g., how many catheters were burst tested) is not specified in this summary.

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 is not applicable as the study involved bench testing and biocompatibility assessments, not a diagnostic judgment by medical experts.

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

Not applicable, as this was not a clinical or diagnostic imaging study requiring expert adjudication.

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 imaging or diagnostic tool.

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

Not applicable. This device is hardware, not an algorithm.

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

The "ground truth" for this device's testing is established by engineering specifications, international standards (e.g., ISO 594-2, ISO 10993 series), and validated test methods to ensure the device performs as intended and is safe for its stated use. For example, the "Pass" result for "Distal tensile strength" means it met a predefined engineering threshold.

8. The sample size for the training set

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

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

Not applicable.

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