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The device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal, arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

The Armada 35/Armada 35 LL Percutaneous Transluminal Angioplasty (PTA) Catheter is a standard over-the-wire (OTW) balloon catheter to be used for percutaneous transluminal angioplasty (PTA). The dual-layer balloon (outer layer: Pebax L25, inner layer Pebax 7233D) will be available in lengths 20, 40, 60, 80, 100, 120, 150, 200 and 250 mm, with nominal diameters of 3, 4, 5, 6, 7, 8, 9, 10, 12 and 14mm. The balloon has a nominal diameter inflation pressure of 4, 6 and 8atm (depending on diameter) and a rated burst pressure between 7 to 28atm (depending on balloon size). Two swaged metal marker bands (PT/ IR) mark the working length of the balloons. The dual-lumen catheter shaft (Grilamid L25) has working lengths of 80 or 135 cm. The catheter shaft differs in outer diameter between 1.73 and 1.90 mm (depending on balloon size). One lumen is used for inflating the balloon and the second lumen allows access to the distal tip of the catheter for guide wire insertion. The inner member, which is constructed either of Grilamid L25 or ELG 6260 (depending on balloon size) will accept a 0.035" guide wire. The balloon, outer shaft of the catheter and the entire inner member is coated with silicone coating. The outer shaft has a polycarbonate y-arm luer adhesively bonded to the proximal end to allow for entry to the guide wire lumen and to allow for connection of the inflation device to the inflation/deflation lumen.

The provided text describes a 510(k) summary for the Armada 35/Armada 35 LL PTA Catheter. This document details the device's characteristics, intended use, and performance data used to demonstrate substantial equivalence to predicate devices. However, it does not provide acceptance criteria in a structured, quantitative table, nor does it detail a study that explicitly proves the device meets such criteria with numerical performance metrics.

Instead, the document lists a series of performance tests that were "successfully completed" to support the claim of substantial equivalence. It is implied that the device's performance in these tests met internal (unspecified) acceptance criteria or demonstrated equivalence to the predicate devices.

Therefore, for the requested information, I will synthesize what is available and note where specific details are missing.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format, nor does it provide specific numerical performance metrics for the Armada 35/35 LL PTA Catheter to contrast against such criteria. The performance data section broadly indicates that various tests were "successfully completed."

Below is a table summarizing the tests, and where possible, general outcomes as implied by the submission:

Additional Information

1. Sample sizes used for the test set and the data provenance:
   The document does not specify the sample sizes used for each of the performance tests. The data provenance is not explicitly stated in terms of country of origin; however, the tests appear to be laboratory-based engineering and biocompatibility tests, not clinical studies. Therefore, terms like "retrospective" or "prospective" are not applicable in the typical clinical study sense.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not applicable. The performance testing described consists of laboratory and bench testing, not assessments requiring expert "ground truth" establishment in a clinical or imaging context.

3. Adjudication method for the test set:
   This information is not applicable, as the tests are not clinical assessments requiring adjudication.

4. 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. The device is a physical medical device (PTA Catheter), not an AI diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   This information is not applicable, as the device is a physical medical device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   This information is not applicable in the clinical sense. The "ground truth" for the engineering and biocompatibility tests would be the established scientific and engineering principles, material specifications, and regulatory standards against which the device's physical and functional properties are measured/tested.

7. The sample size for the training set:
   This information is not applicable, as the device is a physical medical device and does not involve AI algorithms that require training sets.

8. How the ground truth for the training set was established:
   This information is not applicable, as the device is a physical medical device and does not involve AI algorithms.

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