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This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. This catheter is not indicated for use in the coronary arteries, stent placement or stent redilation.

The Mullins X™ catheter is an Ultra High Pressure Dilatation catheter recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac and renal arteries. The catheter is a coaxial over the wire catheter with a balloon near the distal tip. One lumen permits guidewire insertion to facilitate advancement of the catheter, while the other lumen is for balloon inflation and deflation.

The balloons of the MULLINS X™ PTA Catheter are made of a non-compliant polymeric material. The two laminate balloon system is designed to inflate to a specific diameter at a given pressure. The change in diameter is minimal over the range of inflation pressures. The balloons are heat bonded to the shaft.

The outer body is made of polymeric tubing, and the inner tubing is comprised of a multi layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The area under the balloon is enhanced with four radiopaque platinum image bands. Two are 5mm on each side of the balloon center and two more under the balloon shoulders.

The catheter is white in color and the balloon material is clear. The catheter balloon diameter and name is stamped onto the Y sleeve and the balloon extension is labeled with balloon diameter x balloon length x introducer size x shaft size x usable length x guidewire size and the catheter lot number. The catheter is packaged in a polyethylene sheath and is double packed in two heat sealed Tyvek pouches.

This document is a 510(k) Pre-market Notification for a medical device, specifically a PTA catheter. It is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission relies on comparisons to existing devices and bench testing, rather than extensive clinical studies with human subjects or AI algorithms as would be required for the information requested.

Therefore, many of the requested categories related to clinical studies, AI algorithms, and ground truth establishment are not applicable to this particular document.

Here's a breakdown of what can be extracted and what cannot:

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

The document does not explicitly state formal "acceptance criteria" with numerical targets for clinical performance in the way an AI study would. Instead, it demonstrates performance through bench testing and comparison to a predicate device.

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. This document refers to bench testing and comparison to a predicate device. It does not involve a "test set" of patient data for evaluating an AI algorithm.
• Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. "Ground truth" in the context of expert consensus is not relevant for this type of device submission. The "ground truth" for a medical device in this context would be its physical and mechanical properties, and its safety and efficacy, demonstrated through bench testing and clinical equivalence to a known predicate.

4. Adjudication method for the test set

Not applicable. There is no "test set" of data requiring expert adjudication.

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 medical device approval for a physical catheter, not an AI algorithm.

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

Not applicable. This is a medical device approval for a physical catheter, not an AI algorithm.

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

The closest concept to "ground truth" here would be:

• Bench Test Results: Objective measurements of the catheter's physical and mechanical properties (e.g., inflation diameter at a given pressure, material strength, radiopacity). These results, which are "on file at NuMED, Inc.", serve as the factual basis for its performance claims.
• Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (NuMED Mullins-X PTA Catheter, K041093, and Z-MED Catheter, K931009) provides the "ground truth" for comparison to establish substantial equivalence.

8. The sample size for the training set

Not applicable. This is a medical device approval for a physical catheter, not an AI algorithm.

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

Not applicable. This is a medical device approval for a physical catheter, not an AI algorithm.

Summary of what the document focuses on:

This 510(k) summary focuses on demonstrating the substantial equivalence of the new Mullins-X PTA Catheter to previously cleared predicate devices by:

• Stating identical materials for biocompatibility.
• Indicating that bench testing was performed according to GMPs, with results on file (though specifics are not in this summary).
• Directly comparing the device's characteristics (indications, size, materials, construction) to a predicate device, showing minimal differences, with the primary difference being an additional balloon diameter.

The content is typical for a 510(k) submission for a non-AI medical device and does not contain the information requested about AI performance or clinical study details.

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