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The Lotus Introducer Set is intended to provide femoral access to the vascular system.

The Lotus™ Introducer Set is a sterile, single-use introducer catheter that provides percutaneous access to the femoral artery for introduction of catheter-based devices into the vascular system. The Lotus Introducer Set will be inserted into the femoral artery using conventional minimally invasive catheterization techniques. The Lotus Introducer Set is composed of a dilator and an introducer sheath with a flush port. The design features a PTFE liner on the ID of the introducer sheath and an external coating on both the introducer sheath and the dilator. When activated, the external hydrophilic coating increases the lubricity of the surface to aid in delivery.

This document is a 510(k) summary for the Creganna-Tactx Lotus Introducer Set. It provides information about the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or details of a study demonstrating the device meets those criteria, as one would expect for an AI/ML medical device.

The information provided (K140338) describes a mechanical medical device (Introducer Catheter), not an AI/ML-driven device. The "Testing" section details a series of in-vitro physical and biocompatibility tests, which are standard for such medical devices, but these are not related to AI/ML performance.

Therefore, for an AI/ML device, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable for a mechanical device. The listed tests are not AI performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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. The document explicitly states "Clinical studies were not deemed necessary since in vivo testing and a literature review were sufficient to demonstrate safety and effectiveness by way of comparison to a legally marketed predicate device."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes the regulatory clearance for a mechanical medical device and does not contain any information relevant to the acceptance criteria or study details for an AI/ML-driven device.

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