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The Wingman 14C Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic agents.

The Wingman 14C Crossing Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature.

The device consists of a support catheter, with a concealed radiopaque beveled guide-tip, and activating handle. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.

The provided text is a 510(k) summary for the ReFlow Medical, Inc. Wingman 14C Crossing Catheter. It describes the device, its intended use, and comparison to a predicate device, as well as a list of performance tests conducted.

However, the document does not contain the kind of information requested in the prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, or details about a multi-reader multi-case (MRMC) study for an AI/device. The device described here is a physical medical catheter, not an AI-powered diagnostic device.

Therefore, I cannot fulfill the request using only the provided text. The questions posed are specifically for a study that proves an AI medical device meets acceptance criteria, which this document does not describe.

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The Wingman 14C Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic agents.

The Wingman 14C Crossing Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature. The device consists of a support catheter, with a concealed radiopaque beveled guide-tip, and activating handle. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents. The Wingman 14C Crossing Catheter has an OD of ~ 0.035" with an ID compatible with 0.014" guidewires. The Wingman 14C Crossing Catheter is available in 90cm, 135cm and 150cm lengths.

The provided text describes a 510(k) premarket notification for a medical device called the "Wingman 14C Crossing Catheter." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific performance acceptance criteria in a clinical or analytical setting.

Therefore, the document does not contain the information requested regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set, data provenance, or details about training sets.
3. Number of experts, their qualifications, or adjudication methods for ground truth establishment.
4. Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or an effect size.
5. Whether a standalone (algorithm-only) performance was done.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
7. How the ground truth for training or test sets was established.

The "Performance Data" section (Page 5) lists various types of engineering and materials performance testing conducted (e.g., Sterilization Validation, Biocompatibility Testing, Simulated Use Testing, Component/Assembly Integrity Testing, Corrosion Resistance Testing, Lubricity Testing). It states that the device "met all specified criteria" for these tests, implying that there were pre-defined acceptance criteria for these engineering and material properties. However, the document does not provide the specific numerical acceptance criteria or the reported results for each of these tests.

In summary, this document is a regulatory submission demonstrating substantial equivalence based on technological characteristics and engineering/material testing, not a clinical study report with detailed performance metrics and ground truth establishment as would be common for AI/ML or diagnostic devices.

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