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A stopcock is a typical element of fluid or drug administration. It is used to control/direct fluid flow and permit fluid access to the patient. A Luer lock plug is used to terminate any open Luer port. The silver antimicrobial additive will enhance performance by minimizing the possibility the devices will be microbially compromised.

The Medex, Inc. antimicrobial stopcock and Luer lock plug are functionally conventional devices, which incorporate antimicrobial properties through the addition of a elemental, metallic silver additive.

This document describes performance testing for Medex, Inc.'s MX531-1LT Antimicrobial IV Set Stopcock and MX491T Antimicrobial Luer Lock Plug.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the study design: to demonstrate a statistically significant reduction in microbial contamination compared to non-antimicrobial counterparts. The specific performance metrics are the percentage reduction in microbial contamination.

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

• Sample Size: 200 units were divided into four groups for the in vitro study. This means 50 units per group. The document doesn't specify if this refers to 200 antimicrobial devices and 200 non-antimicrobial devices, or 200 total devices (100 of each type). Given the comparative nature, it's highly probable it refers to 200 of each type (antimicrobial and non-antimicrobial) or 100 of each type to make up the 200 units. Assuming the "200 units" refers to the entire study, it would be 100 antimicrobial and 100 non-antimicrobial devices for comparison.
• Data Provenance: The study was an in vitro study. No country of origin is specified for the data, but it's likely connected to Medex, Inc. in Dublin, Ohio, USA. Since it's an in vitro study, the concept of "retrospective or prospective" doesn't directly apply in the same way it would to human clinical trials; it's a controlled laboratory experiment.

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

Not applicable. This was an in vitro microbiological study, not a study requiring expert interpretation of medical images or patient data. The "ground truth" was the measured microbial contamination (CFU count).

4. Adjudication Method for the Test Set

Not applicable. As an in vitro study measuring quantifiable microbial counts, there was no need for 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 not an AI/imaging device, but an antimicrobial medical device designed for fluid administration.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm, but a physical medical device. The "standalone" performance here refers to the device's ability to reduce microbial contamination on its own in a controlled environment.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth was direct measurement of microbial contamination in Colony Forming Units (CFUs).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is a physical medical device undergoing performance testing, not a machine learning model.

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

Not applicable. There is no "training set" or corresponding ground truth establishment in the context of this device's performance testing. The "ground truth" related to its antimicrobial efficacy was established through direct empirical measurement of bacterial and fungal growth in a controlled laboratory setting.

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