Search Results

The VSI StraitSet micro-introducer kit is intended for use in percutaneous introduction and placement of catheters and guidewires.

The VSI StraitSet is a 6F x 20cm triaxial introducer comprised of a sheath (with hydrophilic or silicone coating), dilator and a stiffening cannula. The VSI StraitSet is packaged as a kit with the following components:

• (1) 0.018" x 60 cm guidewire
• (1) 21 G x 7 cm echogenic access needle or (1) 21 G 15 cm echogenic trocar needle with depth markings and locking stylet
• Optional: (1) 0.038" x 145 cm. 3 mm "J"/straight guidewire

The provided document is a 510(k) summary for the VSI StraitSet micro-introducer kit. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, it does not include the detailed information requested regarding acceptance criteria and a specific study proving the device meets those criteria in the context of AI/ML performance.

The document discusses device verification tests such as kink radius, fluoroscopy visualization, friction force, simulated use, and various biocompatibility tests. It states that "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues." However, it does not explicitly list those acceptance criteria or detailed results in the format of "reported device performance." Moreover, this document describes a traditional medical device (micro-introducer kit) and not an AI/ML-driven device.

Therefore, I cannot provide the requested information because:

1. No Acceptance Criteria Table: The document states that verification tests "met the specified acceptance criteria" but does not explicitly list these criteria in a table or otherwise.
2. No Reported Device Performance Table: While the document implies successful performance, it does not provide quantitative "reported device performance" against specific criteria.
3. Not an AI/ML Device: The questions about sample size, data provenance, expert ground truth, adjudication method, MRMC studies, standalone performance, and training set details are specifically relevant to AI/ML devices. This document describes a physical medical device (micro-introducer kit) and its mechanical and biocompatibility testing. These questions are, therefore, not applicable to the content provided.

Ask a specific question about this device