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The Mahurkar™ Elite Acute Dual Lumen Catheter is indicated for short-term central venous access for hemodialysis, apheresis, and infusion.

The Mahurkar™ Elite Acute Triple Lumen Catheter is indicated for short-term central venous access for hemodialysis, apheresis, infusion, central venous pressure monitoring, and pressure injection of contrast media. The maximum recommended infusion rate is 5 ml/sec for power injection of contrast media.

The Mahurkar™ Elite Acute Dual Lumen Catheter features a two lumen design. The proximal end has color-coded adapters to indicate arterial and venous flow. The adapters are connected to extension tubes which are available in curved or straight configurations. The extension tubes are connected to the hub which is joined to a dual lumen shaft available in pre-curved and straight configurations. The shaft extends to side slots near the distal tip. The dual lumen catheter is available in 12.0 Fr or 13.5 Fr outer diameters and a variety of implant lengths ranging from 13 cm to 30 cm. It is offered as a single device or as convenience kits.

The Mahurkar™ Elite Acute Triple Lumen Catheter features a three lumen design. The proximal end has color-coded adapters to indicate arterial flow, venous flow, and medial infusion. The adapters are connected to extension tubes which are available in curved or straight configurations. The extension tubes are connected to the hub which is joined to a triple lumen shaft that extends to side slots near the distal tip. The triple lumen catheter is available in 12.5 Fr outer diameter and a variety of implant lengths ranging from 13 cm to 30 cm. It is offered as a single device or as convenience kits.

This document describes a 510(k) submission for new catheter devices and not a study for AI/ML device. Therefore, I cannot extract the requested an AI/ML device study information from this document.

However, I can provide available information about the device's performance testing.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document does not specify the sample sizes used for each of the bench-top functional and performance tests.
• The data provenance is from bench-top functional and performance testing and biocompatibility testing, which are laboratory-based tests. There is no information about country of origin in the context of data.

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

• This information is not applicable as the document describes physical device performance tests, not clinical studies involving expert interpretation.

4. Adjudication method for the test set:

• This information is not applicable for the type of testing described (bench-top and biocompatibility).

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:

• This information is not applicable as this document describes a medical device (catheter) and not an AI/ML device.

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

• This information is not applicable as this document describes a medical device (catheter) and not an AI/ML device.

7. The type of ground truth used:

• The ground truth for the performance testing was based on "relevant product specifications". This implies pre-defined engineering and safety standards for catheter performance.
• For biocompatibility, the ground truth was adherence to ISO 10993: Biological Evaluation of Medical Devices.

8. The sample size for the training set:

• This information is not applicable as this document describes a medical device (catheter) and not an AI/ML device that requires a training set.

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

• This information is not applicable as this document describes a medical device (catheter) and not an AI/ML device that requires a training set.

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