Search Results

The CROSSWALK™ Peripheral Support Catheter is intended to provide support to facilitate the placement of guide wires in the peripheral vasculature, and can be used to exchange one guide wire for another. The CROSSWALK™ Peripheral Support Catheter is also intended to assist in the delivery of contrast media into the peripheral vasculature.

Device Description

The ASAHI CROSSWALK™ Peripheral Support Catheters (PSC) are a single lumen catheter with a three layer construction that is composed of a braid reinforced polymer shaft over a PTFE liner. The catheter also has a proximal female hub, a distal radiopaque atraumatic tip, hydrophilic coating and tungsten loaded radiopaque markers on the distal outer surface of the catheter.

There are three sizes in the family, a 0.035", 0.018" and 0.014" quidewire compatible models, whereas the 0.018" and 0.014" models are designed to fit into the 0.035" model for additional proximal support.

AI/ML Overview

The provided text describes the regulatory submission for the ASAHI CROSSWALK™ Peripheral Support Catheter and details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device, the ASAHI Corsair Armet.

It does not describe a study involving an AI-powered device or a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss ground truth established by experts or a training set. The device in question is a physical medical catheter, not a software device that would require AI-specific performance criteria.

Therefore, I cannot fulfill most of the requested information regarding acceptance criteria and study proving an AI device's performance (points 2 through 9 in your prompt).

However, I can extract the acceptance criteria and performance data for the physical catheter.

Study Proving Device Meets Acceptance Criteria for ASAHI CROSSWALK™ Peripheral Support Catheter

This document describes the non-clinical bench testing conducted for the ASAHI CROSSWALK™ Peripheral Support Catheter to demonstrate substantial equivalence to its predicate device, ASAHI Corsair Armet. This is a physical medical device, not an AI-powered software.

1. Table of Acceptance Criteria and Reported Device Performance

The general statement provided is that the device met all acceptance criteria for the listed tests and performed similarly to the predicate devices. Specific quantitative acceptance criteria or detailed numerical performance results for each test are not provided in this summary.

Test Performed	Acceptance Criteria Source / General Outcome
Visual Inspection	Met acceptance criteria; performed similarly to predicate.
Corrosion Resistance	Met acceptance criteria; performed similarly to predicate.
Force Break	Met acceptance criteria; performed similarly to predicate.
Liquid Leak	Met acceptance criteria; performed similarly to predicate.
Air Leak	Met acceptance criteria; performed similarly to predicate.
Radio-Detectability	Met acceptance criteria; performed similarly to predicate.
Torque Transmission	Met acceptance criteria; performed similarly to predicate.
Torque Durability	Met acceptance criteria; performed similarly to predicate.
Slide Durability	Met acceptance criteria; performed similarly to predicate.
Kink Resistance	Met acceptance criteria; performed similarly to predicate.
Flow Test	Met acceptance criteria; performed similarly to predicate.
Dimensions	Met acceptance criteria; performed similarly to predicate.
Coating Integrity	Met acceptance criteria; performed similarly to predicate.
Biocompatibility	Verified in accordance with ISO10993-1. Results provide assurance of a safe biocompatibility profile.

Note on Acceptance Criteria:

Acceptance criteria for tests conducted per ISO10555-1 were based on that standard.
Tests not conducted per ISO10555-1 used "in-house validated procedures with internally developed acceptance criteria."
"All ASAHI CROSSWALK™ Peripheral Support Catheter test samples met the acceptance criteria for each of the tests listed in this submission. There were no deviations from the acceptance criteria."

Information Not Applicable (N/A) or Not Provided in the Document:

As the document pertains to a physical medical device and not an AI-powered software, the following points are not relevant or cannot be extracted from the provided text:

Sample size used for the test set and data provenance: The document states "test samples" were used for the non-clinical bench tests but does not specify the exact number of units tested for each test. Data provenance (country of origin, retrospective/prospective) is not applicable to bench testing of physical device properties.
Number of experts used to establish the ground truth for the test set and qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth for physical device performance is established through engineered specifications and recognized standards (e.g., ISO).
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This refers to human expert adjudication in diagnostic studies, not physical device testing.
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 does not involve human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for physical device testing is typically based on engineering specifications, industry standards (e.g., ISO), and validated measurement techniques. It's not clinical "ground truth" derived from patient data or expert consensus.
The sample size for the training set: Not applicable. This device is not an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable. This device is not an AI model.

Ask a Question

Ask a specific question about this device

Page 1 of 1