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The Flash PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty in the peripheral vasculature at aorto-ostial locations, including iliac, renal and carotid arteries. This catheter is not intended for use in coronary arteries.

The Flash PTA Balloon Dilatation Catheter is a 0.014" guidewire-compatible, rapid exchange (RX) angioplasty balloon catheter with proximal anchoring. The device uses a dual balloon design featuring a compliant anchoring balloon, which enables the operator to precisely position the catheter at aorto-ostial anatomies and prevent distal migration of the balloon during angioplasty. The second semi-compliant high pressure balloon allows for luminal dilatation.

The provided text describes a 510(k) premarket notification for the Flash PTA Balloon Dilatation Catheter. It focuses on demonstrating substantial equivalence to a previously cleared device (K102482) and reports on bench testing for product line extensions.

The document does not contain information on acceptance criteria or a study proving the device meets those criteria in a clinical setting. The performance data section exclusively mentions "Bench testing."

Therefore, most of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or directly stated based on the given document:

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

Explanation: The document states, "All test results demonstrate that the materials, manufacturing process, and design of the Flash PTA Balloon Dilatation Catheter meet the established specifications necessary for consistent performance according to its intended use." This indicates that for each bench test listed, there were pre-defined acceptance criteria (specifications) that the device successfully met. However, the exact numerical or qualitative specifications themselves are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample size: Not specified. The document only mentions "Bench testing performed."
• Data provenance: Not specified. This was bench testing, not human or animal study data.

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

• Not applicable. This document describes bench testing of a physical medical device, not a diagnostic algorithm that requires expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. This document describes bench testing of a physical medical device.

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:

• No. This document is for a physical balloon catheter, not an AI or diagnostic imaging device.

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

• No. This document is for a physical balloon catheter.

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

• Not applicable. For physical device bench testing, "ground truth" refers to the established engineering specifications and physical measurements.

8. The sample size for the training set:

• Not applicable. There is no mention of a training set as this is not an algorithm being developed.

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

• Not applicable. There is no mention of a training set.

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