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The Atlas® Gold PTA Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the peripheral vasculature, including the iliac arteries and iliac and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.

The Atlas® Gold PTA Dilatation Catheter is a high performance balloon catheter consisting of an over-the-wire catheter with a balloon fixed at the distal tip. The proprietary non-compliant, low profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes a tapered atraumatic tip to facilitate advancement of the catheter to and through the stenosis. The proximal portion of the catheter includes a female luer lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. The over-the-wire catheter is compatible with .035" guidewire and is available in 80 cm and 120 cm working lengths. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A rewrapping tool is also provided on the catheter shaft to aid in re-wrap/refolding of the balloon. This product is not manufactured with any natural rubber latex.

This document describes the premarket notification (510(k)) for the Atlas® Gold PTA Dilatation Catheter (K181323). The information provided is sufficient to answer some but not all of the requested categories, as this is a medical device clearance document rather than a detailed clinical study report for an AI/software as a medical device (SaMD). The core of this submission is to demonstrate substantial equivalence to a predicate device, with an expanded indication for use.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance (for the expanded indication - venous system use):

The primary acceptance criterion mentioned is related to safety for the expanded indication in the venous system.

Study Proving the Device Meets Acceptance Criteria:

1. Sample Size and Data Provenance:

   • Sample Size: 61 patients for post-stent dilatation and 20 patients for pre-dilatation. (Total 81 patient procedures where the device was used).
   • Data Provenance: Retrospective, investigator-sponsored clinical study. Location of data origin (country) is not explicitly stated, but it's part of a US FDA submission. The study covered data between September 1, 2013, and May 30, 2017.

2. Number of Experts and Qualifications for Ground Truth:

   • This document describes a clinical study of a physical medical device (catheter), not an AI/SaMD. Therefore, the concept of "experts establishing ground truth for a test set" in the context of image interpretation or algorithm performance is not applicable here. The "ground truth" implicitly relies on standard clinical assessment during the procedures and follow-up, observed by the investigators.

3. Adjudication Method for the Test Set:

   • Not specified, as this is a device performance study, not an AI/SaMD study involving human reader variability in interpretation.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Not applicable. This study is for a physical medical device, not an AI/SaMD requiring assessment of human reader improvement with AI assistance.

5. Standalone (Algorithm Only) Performance:

   • Not applicable. This study is for a physical medical device; there is no standalone algorithm to evaluate.

6. Type of Ground Truth Used:

   • The "ground truth" for this study is based on clinical outcomes and observations during the procedure. Specifically, it's defined by the occurrence (or absence) of major adverse events (acute thrombosis, perforation, device-related complications) and measurements of luminal area.

7. Sample Size for the Training Set:

   • Not applicable. This is a clinical validation study for a physical device, not an AI model that requires a training set. The device itself was developed and manufactured based on established engineering and quality system processes.

8. How Ground Truth for the Training Set Was Established:

   • Not applicable for the same reason as above. The "training" for such a device comes from engineering design, materials science, and in-vitro/in-vivo testing during the development phase, not from a "training set" of data in the AI sense.

Additional Information from the Document:

• Identicality to Predicate: The key argument for substantial equivalence is that the subject device (Atlas® Gold PTA Dilatation Catheter) is identical to its predicate device (Atlas® Gold PTA Dilatation Catheter, K122984) in manufacturing and design.
• Only Differences: The only differences are an expanded indications for use to include the venous system and the inclusion of the retrospective clinical study results in the labeling.
• Clinical Literature Review: The submission also included reviews of 46 published clinical articles involving over 4000 patients, demonstrating that PTA catheters are generally safe for use in the venous system, with known and low rates of adverse events.

In summary, this submission relies on demonstrating the safety and effectiveness of using an already cleared and identical physical device for an expanded indication based on a retrospective clinical study showing favorable outcomes against defined safety benchmarks, supplemented by existing literature. It's not a study designed to evaluate an AI/software component.

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