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MAHURKAR® Triple Lumen Catheter is intended for short-term central venous access for hemodialysis, apheresis, and infusion.

The MAHURKAR® Triple Lumen Catheter features three lumens. The catheter has a 12 Fr radiopaque polyurethane catheter shaft with two large lumens and one smaller medial lumen running longitudinally along the length of the catheter shaft. The lumina can be distinguished by the color-coded luer-lock adapters on the clear silicone rubber extensions. The two large lumens have curved extensions, and the smaller medial lumen has straight extension tubing. The catheter is available in various implantable lengths.

MAHURKAR® Triple Lumen Catheter is available in singles, kit or tray configuration which contains the sterile catheter as well as accessory items needed for insertion.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document implies the predicate device's infection rate is the benchmark for acceptability.

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

• Sample Size (Evaluable Patients): 393 patients
• Total Patients in Study: 485 patients
• Data Provenance: Multi-centered, prospective, randomized clinical study. The country of origin is not explicitly stated, but the FDA approval letter suggests it's within the US regulatory framework.

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

This information is not provided in the document. The study assessed "catheter related blood stream infection" as the primary outcome, which would typically be diagnosed by clinicians, but the specific number or qualifications of these diagnosticians are not mentioned.

4. Adjudication Method for the Test Set

This information is not explicitly stated in the document. The study design mentions "evaluable patients" and a "comparison" between two catheters, but doesn't detail how the primary outcome (infection) was adjudicated if there were discrepancies.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done in the context of comparing human readers with and without AI assistance. This study is a clinical comparison of two medical devices (catheters) based on infection rates.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not done. This study is a clinical trial comparing the performance of a new catheter with a predicate catheter.

7. Type of Ground Truth Used

The ground truth used was clinical outcome data, specifically "catheter related blood stream infection for each patient at the time of catheter removal." This implies a definitive clinical diagnosis based on established medical criteria for infection.

8. Sample Size for the Training Set

The document describes a clinical study to evaluate the device's performance, not a study to train an algorithm. Therefore, there is no training set in the context of this document.

9. How the Ground Truth for the Training Set Was Established

Since there was no training set for an algorithm, this question is not applicable. The ground truth for the clinical study was established through the diagnosis of catheter-related blood stream infections in patients.

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