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This catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, and renal arteries. These catheters are not designed to be used in the coronary arteries.

The NuMED, Inc. MULLINS™ PTA Catheter is a co-axial over-the-wire catheter with a balloon near the distal tip. It is available in sizes of 12-20mm diameter and 3-4cm in length. 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 NuMED, Inc. MULLINS™ PTA Catheter is made of a noncompliant polymeric material and are the same balloons that are used on the approved Z-MED Catheter (K931009, K991977, and K011557). 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 and inner body tubing are made of polymeric tubing. The area under the balloon is enhanced with five radiopaque platinum image bands. Two that are 5mm on each side of the balloon center and two more under the balloon shoulders. An additional image band is imbedded into the tip of the catheter as an additional safety measure.

This document is a 510(k) premarket notification for the NuMED Mullins PTA Catheter. It claims substantial equivalence to the NuMED Z-MED PTA Catheter. The information provided is primarily focused on the device description, biocompatibility, and bench testing, rather than explicit acceptance criteria and a detailed study report with performance metrics.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the document, direct, quantifiable acceptance criteria with corresponding performance results are not explicitly stated in a table format. The submission relies on demonstrating substantial equivalence to a predicate device by comparing design, materials, and intended use. The "acceptance criteria" can be inferred as meeting the standards and performance of the predicate device and relevant biocompatibility/bench testing.

Missing specific quantifiable acceptance criteria and performance data. The document states that test results are "on file at NuMED, Inc.", indicating that the detailed data was submitted to the FDA but is not included in this summary.

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

• Sample Size: Not specified. The document only mentions "Biocompatibility Testing" and "Laboratory (Bench) Testing" without indicating the number of devices or components tested.
• Data Provenance: The tests were conducted internally by NuMED, Inc. ("on file at NuMED, Inc."). The document does not specify the country of origin of the data beyond "NuMED, Inc.", which is based in Hopkinton, NY, USA. The testing appears to be retrospective in the sense that the results were submitted for a premarket notification for a device that has undergone testing.

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

This type of information is not applicable to this submission. The device is a medical catheter, and its evaluation relies on physical and material properties, mechanical testing, and biocompatibility, not on expert interpretation of medical images or clinical data to establish a ground truth for a diagnostic output.

4. Adjudication Method for the Test Set

This is not applicable for the reasons stated above. There's no "ground truth" established by experts or adjudication involved in the type of testing described (biocompatibility, bench testing).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. The device is a medical catheter, not an AI-powered diagnostic tool requiring human readability or interpretation. Therefore, there's no comparison of human readers with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable. The device is a physical medical instrument, not an algorithm or AI system.

7. Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness relies on:

• Biocompatibility Standards: Compliance with the "Tripartite Biocompatibility Guidance for Medical Devices."
• Engineering Standards: Meeting the device's design specifications for dimensions, material integrity, and functionality (e.g., balloon inflation properties).
• Good Manufacturing Practices (GMPs): Adherence to quality system requirements during testing.

There is no "ground truth" derived from expert consensus, pathology, or outcomes data in the context of diagnostic interpretation, as this is an interventional device.

8. Sample Size for the Training Set

This is not applicable. The device is a physical medical instrument, not an AI algorithm that requires a training set.

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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