Search Results

The Vaccess TM PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

The Vaccess™ PTA Balloon Dilatation Catheter is a coaxial lumen catheter with a balloon mounted on its distal tip. One lumen accommodates the insertion of the guidewire and the second provides a channel for balloon inflation/deflation. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature.

The provided document is a 510(k) summary for the Vaccess™ PTA Balloon Dilatation Catheter. It outlines the device's description, indications for use, and a comparison to a predicate device. However, it does not contain detailed information about specific acceptance criteria or the study that proves the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or reader improvement.

The document states:
"The Vaccess™ PTA Balloon Dilatation Catheter met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

This is a general statement of compliance, but it does not provide the specific data requested in the prompt. The 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device based on technological characteristics and intended use, rather than presenting a detailed performance study with quantitative acceptance criteria typically seen for diagnostic AI/ML devices.

Therefore, I cannot provide the requested information from the given text. The document does not include:

1. A table of acceptance criteria and the reported device performance: No such table is present. The document focuses on "design verification and validation" and "substantial equivalence."
2. Sample size used for the test set and the data provenance: No information on test set sample size or data provenance is provided.
3. Number of experts used to establish the ground truth... and their qualifications: Not mentioned.
4. Adjudication method: Not mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned and typically not required for this type of device (a balloon dilatation catheter is an interventional device, not a diagnostic AI/ML device).
6. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable for this device type.
7. Type of ground truth used: Not mentioned.
8. Sample size for the training set: Not applicable for this device type.
9. How the ground truth for the training set was established: Not applicable for this device type.

Ask a specific question about this device