(27 days)
The Bard® ConquestTM PTA Balloon Dilatation Catheter is recommended 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 Bard® Conquest™ PTA Balloon Dilatation Catheter is a coaxial lumen catheter with a balloon mounted on its distal tip. One lumen accommodates the insertion guidewire and the second provides a channel for inflation/deflation of the balloon. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature.
This document describes the Bard® Conquest™ PTA Balloon Dilatation Catheter, a medical device. The information provided is a 510(k) summary for the purpose of demonstrating substantial equivalence to a predicate device, not a study evaluating acceptance criteria for an AI/ML-driven medical device. Therefore, much of the requested information regarding acceptance criteria, study methodologies, and AI-specific performance metrics is not present in the provided text.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria. Instead, it relies on demonstrating "substantial equivalence" to a predicate device through "bench testing."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantially equivalent to predicate device | Bench testing shows that the modified catheter is substantially equivalent to the predicate device, the Opti-Plast Centurion™ 5.5 Fr PTA Catheter. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided. The document mentions "bench testing" but does not detail the sample size or the nature of the test set beyond that.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable and not provided. "Bench testing" typically refers to engineering tests performed in a lab setting, not clinical studies requiring expert ground truth for interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable and not provided.
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
This information is not applicable and not provided. This is a medical device, not an AI-driven diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For "bench testing," the "ground truth" would be the established engineering specifications and performance standards for the predicate device. The document does not explicitly state the specific parameters or their "ground truth" values against which the new device's performance was measured, but it implies comparison to the predicate's known characteristics.
8. The sample size for the training set
This information is not applicable and not provided. There is no mention of a training set as this is not an AI/ML-based device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. There is no mention of a training set.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).