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The Venture 0.014" catheters are indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature. The OTW version (Model 5821) may also be used for manual delivery of saline solution or diagnostic contrast agents.

The Venture 0.014" catheters are single lumen catheters with a radiopaque deflectable distal tip designed to provide guidewire support during interventional procedures in the coronary and peripheral vasculature. The Venture 0.014" catheters are compatible with 0.014" guidewires and are available in two configurations. The rapid exchange configuration consists of a hypotube shaft with a rapid exchange (RX) lumen and deflectable tip on the distal segment. The over the wire configuration consists of an over-the-wire (OTW) lumen that runs the entire length of the catheter with a deflectable tip. The Venture 0.014" catheter tips are deflectable 90° by rotating a deflection knob on the control handle of the proximal end and a hydrophilic coating on the distal end of the catheter enhances deliverability to the target vasculature. The Venture 0.014" catheters are sterilized with ethylene oxide.

This is a 510(k) summary for a medical device (Venture 0.014" Catheter), not an AI/ML device study. Therefore, many of the requested categories for AI/ML device studies are not applicable or cannot be extracted from this document.

However, I can extract the acceptance criteria and performance data for the device's functional integrity as described in the document.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify exact sample sizes for each bench test. It generically states "The results of the verification tests met the specified acceptance criteria."
• Data provenance is not explicitly stated, but these are bench tests performed by the manufacturer, Vascular Solutions, LLC. This is not a study on patient data.

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

• Not applicable. This is not an AI/ML study involving expert ground truth for medical images or clinical outcomes. These are engineering bench tests.

4. Adjudication method for the test set:

• Not applicable. This is not an AI/ML study involving expert interpretation or adjudication.

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. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the bench tests, the "ground truth" is established by engineering specifications and standards for device performance (e.g., specific force, angle, integrity measurements).
• For biocompatibility, the ground truth is established by the results of standardized biological tests according to ISO 10993-1.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no training set in the AI sense.

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

• Not applicable.

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