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The Armada 18 is indicated to dilate stenosis in femoral, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, the device is also indicated for post-dilatation of balloon-expandable and self-expanding stents.

The Armada 18 is indicated to dilate stenosis in femoral, popliteal, infra-popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, the device is also indicated for post-dilatation of balloonexpandable and self-expanding stents.

The Armada 18 is a 0.018" guide wire compatible and Over-the-Wire catheter used for Percutaneous Transluminal Angioplasty (PTA) procedures. The single-laver balloon is available in lengths of 20 to 200 mm with nominal diameters of 2.0 to 6.0 mm. The catheter shaft has working lengths of 90 or 150 cm.

There are two radiopaque marker bands for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating section of the balloon and help in balloon placement.

An adaption arm is provided on the proximal end of the dilatation catheter to provide access to the inflation lumen and the guide wire lumen. It is designed with a luer-lock fitting for connection with an inflation device. The balloon is inflated using the side port, at which point the balloon expands to a known diameter at specific pressures. The working pressure range for the balloon is between the nominal pressure and the rated burst pressure. All balloons distend to diameters above the nominal diameter when inflated to pressures greater than the nominal pressure.

The Armada 18 PTA Catheter is sterilized with ethylene oxide (EO) and is intended for single use.

This document is a 510(k) summary for the Armada 18 PTA Catheter, a medical device used for percutaneous transluminal angioplasty (PTA) procedures. It describes the device, its intended use, and the performance testing conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis based on your request, highlighting what information is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists the types of performance tests conducted and states that the device "met all acceptance criteria." However, it does not provide a specific table detailing the acceptance criteria for each test or the exact performance values achieved against those criteria. It's a high-level summary confirming compliance.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for any of the performance tests. It only lists the types of tests conducted.

The provenance of the data is in vitro bench testing, meaning tests conducted in a controlled laboratory environment on the device itself. It is not patient data, so there is no country of origin or retrospective/prospective distinction in this context.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document describes bench testing of a physical medical device, not a diagnostic algorithm that requires expert-established ground truth from patient data.

4. Adjudication Method for the Test Set

This is not applicable for the same reason as point 3. Bench testing results are typically based on predefined physical and material science metrics, not expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This is not applicable. The document describes in vitro bench testing of a physical device, not an AI/medical imaging algorithm requiring an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable. The document describes in vitro bench testing of a physical device. There is no algorithm involved in the performance testing described.

7. The Type of Ground Truth Used

For the performance tests described, the "ground truth" would be the predefined engineering specifications, international standards, and internal quality control metrics for the physical characteristics and performance of the catheter. For example, a burst pressure test would have a "ground truth" of a minimum pressure the balloon must withstand. Biocompatibility testing compares results against established biological safety standards.

8. The Sample Size for the Training Set

This is not applicable. The document describes in vitro bench testing of a physical device. There is no "training set" in the context of device performance testing; rather, it refers to the batches/samples of the manufactured device tested. The number of units tested per batch or for validation is not provided.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as point 8.

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