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The ADMIRAL XTREME™ (PTA) Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The ADMIRAL XTREME™ PTA Catheter is an OTW PTA catheter with a semi-compliant inflatable balloon mounted at the distal tip. It is a dual lumen catheter with a guidewire lumen and a balloon inflation lumen. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Two radiopaque marker bands are placed under the balloon segment of the catheter shaft to provide visual reference points for balloon positioning within the vessel. The distal catheter shaft and balloon cones are hydrophilic coated (balloon excluded). The maximum recommended guidewire diameter is 0.035". The device is available in balloon diameters of 3-12mm, balloon lengths of 20, 40, 60, 80 and 120mm and catheter lengths of 80 and 130cm.

The provided text describes a 510(k) summary for the ADMIRAL XTREME™ Percutaneous Transluminal Angioplasty (PTA) Catheter. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study with acceptance criteria for a novel device's performance.

Therefore, many of the requested details about acceptance criteria, clinical studies, sample sizes, and expert validation are not applicable as this submission is for a medical device cleared via the 510(k) pathway, which relies on demonstrating equivalence to an already approved device rather than proving clinical efficacy or diagnostic accuracy through a standalone study.

However, I can extract the relevant information regarding the performance data provided to establish equivalence.

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

Since this is a 510(k) submission for a non-diagnostic device, the "acceptance criteria" are related to in vitro engineering performance equivalence rather than clinical outcomes or diagnostic metrics. The document states that the testing "met the specified requirements" and were "comparable with the predicate device." Specific numerical acceptance values are not provided in this summary.

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

• Sample Size: Not specified for any of the in vitro tests.
• Data Provenance: The testing was "in vitro," implying laboratory testing rather than human subject data. Country of origin not specified, but the manufacturer is Invatec Innovative Technologies in Roncadelle (BS) Italy, and the submitter is ev3 Inc. in Plymouth, MN, USA.
• Retrospective or Prospective: Not applicable for in vitro laboratory testing.

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)

Not applicable. This device's performance was evaluated through engineering in vitro testing; it does not involve expert-established ground truth like in a diagnostic AI study.

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

Not applicable. There was no human expert adjudication of test results in the context of diagnostic accuracy.

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

Not applicable. This is a physical medical device (catheter), not an AI diagnostic tool. No MRMC study was conducted.

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

Not applicable. This is a physical medical device (catheter), not an algorithm.

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

Not applicable. The "ground truth" for the performance evaluation of this catheter was based on established engineering specifications and benchmarks to demonstrate equivalence to the predicate device. For example, balloon burst pressure would have a specified engineering tolerance rather than an expert consensus.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; therefore, there is no "training set."

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

Not applicable. As there is no training set.

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