Search Results

The ReCross Dual Lumen guide wire support catheter with hydrophilic coating is intended to support a guide wire during access of coronary and/or peripheral vasculature and allows for exchange of guide wires and provides a conduit for the delivery of diagnostic contrast agents. The catheter is not intended for use in the neurovasculature.

The ReCross is a dual lumen catheter intended to use in the coronary and/or peripheral vasculature. The ReCross is a 0.014" Over The Wire (OTW) guide wire support catheter. The ReCross has two over the wire OTW lumens that runs the length of the catheter. The ReCross has two depth markings located at 95 cm and 105 cm from the distal tip. The ReCross has a radiopaque marker identifying the distal end of the catheter, a second radiopaque marker in the stylet lumen located 8 mm from the distal tip identifies the distal end of the OTW lumen and a third radiopaque marker in the tip lumen located at 12 mm from the distal tip indentifying the side port. To reduce friction in the guide catheter and vasculature, the distal shaft is fitted with a hydrophilic coating. To reduce friction of the guide wire in the lumens of the ReCross are coated with MDX (silicone) coating. To ease catheter loading into the hemostasis device and the guiding catheter a removable stylet is placed in the stylet lumen

The provided text is a 510(k) summary for the ReCross Dual Lumen guide wire support catheter. It discusses the device's technical characteristics and studies performed to demonstrate its substantial equivalence to a predicate device. However, it does not contain information about an AI/ML-based device, nor does it detail acceptance criteria related to algorithmic performance metrics (like accuracy, sensitivity, specificity, etc.) or clinical study designs involving human readers or standalone AI performance.

Therefore, many of the requested details, such as the number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information, are not present in this document. This document focuses on the mechanical and material performance of a medical device (a catheter), not a diagnostic algorithm.

Based on the provided text, here's what can be extracted regarding acceptance criteria and performance:

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

The document lists various performance tests and states that "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues." However, the specific numerical acceptance criteria for each test are not explicitly provided in this summary, nor are the numerical results for each test. Instead, it indicates that the device passed these tests.

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

• Sample Size: Not specified in the summary. The tests performed are engineering and material verification tests, which typically involve a specified number of samples for each test (e.g., n=3, n=5, n=10 per batch), but this detail isn't included here.
• Data Provenance: Not applicable in the context of clinical data for an AI/ML device. These are laboratory verification tests on the physical catheter device, likely performed at the manufacturer's facility (IMDS Operations B.V., Roden, The Netherlands) or by a qualified testing lab. The data would be prospective in the sense that the tests were conducted specifically for this submission.

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

This is not applicable to this document. The "ground truth" here is meeting engineering specifications and biocompatibility standards, not clinical diagnostic labels established by medical experts for image interpretation or similar tasks.

4. Adjudication method for the test set:

This is not applicable. There's no clinical imaging data or human interpretation involved that would require an adjudication method. The verification tests have objective pass/fail criteria.

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:

This is not applicable. This document describes a physical medical device (catheter), not an AI/ML diagnostic or assistive tool.

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

This is not applicable. There is no algorithm being evaluated here.

7. The type of ground truth used:

The "ground truth" for these tests are established engineering specifications, material standards (like ISO 10993-1 for biocompatibility), and internal quality control criteria for the device's physical and functional properties.

8. The sample size for the training set:

This is not applicable. This is a physical device, not an AI/ML model that requires training data.

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

This is not applicable.

Ask a specific question about this device