(32 days)
For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The Advance® 14Rx Rapid Exchange PTA Balloon Dilatation Catheter is a rapid exchange catheter indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device with 4.0 French nylon tubing compatible with a 0.014-inch guidewire. It will be supplied sterile, intended for one-time use.
The provided document describes the Advance® 14Rx Rapid Exchange PTA Balloon Dilatation Catheter, a medical device used for percutaneous transluminal angioplasty (PTA). This submission is a 510(k) Premarket Notification, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.
The document does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of AI/machine learning performance. Instead, it details the safety and performance testing of a physical medical device. Therefore, many of the requested bullet points, which are relevant to AI/ML device studies, cannot be answered from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Performance Tests | The device was subjected to the following tests: |
| Tensile strength | Results provide reasonable assurance of conformance for use as a PTA dilatation balloon catheter. |
| Balloon inflation/deflation reliability | Results provide reasonable assurance of conformance for use as a PTA dilatation balloon catheter. |
| Balloon burst pressure | Results provide reasonable assurance of conformance for use as a PTA dilatation balloon catheter. |
| Balloon compliance | Results provide reasonable assurance of conformance for use as a PTA dilatation balloon catheter. |
| Balloon fatigue resistance | Results provide reasonable assurance of conformance for use as a PTA dilatation balloon catheter. |
| Bond strength | Results provide reasonable assurance of conformance for use as a PTA dilatation balloon catheter. |
| Biological/Sterility Tests | |
| Biocompatibility | Results provide reasonable assurance of conformance for use as a PTA dilatation balloon catheter. |
| Sterility | Results provide reasonable assurance of conformance for use as a PTA dilatation balloon catheter. |
| Durability/Stability Tests | |
| Shelf life | Results provide reasonable assurance of conformance for use as a PTA dilatation balloon catheter. |
| In Vivo Testing | |
| Animal test (performance in biological system) | Results provide reasonable assurance of conformance for use as a PTA dilatation balloon 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 in the document. The tests performed are engineering, material, and biological tests for a physical device, not an AI model.
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 as the document describes the testing of a physical medical device, not an AI/ML diagnostic or prognostic system requiring expert-established ground truth from medical images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as point 3.
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 as the document describes the testing of a physical medical device, not an AI assistance system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the document describes the testing of a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the physical device, the "ground truth" would be the engineering specifications and performance standards established for such devices (e.g., specific tensile strength values, burst pressures, biocompatibility standards). The document states that the tests provide "reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a PTA dilatation balloon catheter," implying compliance with these established standards. However, the specific quantitative "ground truth" values are not explicitly listed.
8. The sample size for the training set
This information is not applicable as there is no mention of an AI/ML training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reasons as point 8.
§ 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).