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These pre-assembled stopcock gangs provide multiple access sites into a common fluid path for the administration of drugs and solutions. The luer connectors on either end of the stopcock gang allow connection to an IV set for fluid administration through an indwelling intravascular catheter.

Stopcock manifold gangs consist of individual stopcocks assembled in series through common luer fittings to form a manifold or stopcock gang. These pre-assembled stopcock gangs provide multiple access sites into a common fluid path for the administration of drugs and solutions. The luer connectors on either end of the stopcock gang allow connection to an IV set for fluid administration through an indwelling intravascular catheter.

Baxter will purchase stopcocks from Medex, Inc. and will assemble individual stopcocks into ganged configurations containing 2, 3 or 5 stopcock units. Baxter will use Medex stopcocks which vary in the number of flow paths (3 or 4 way), internal lumen diameter (large bore or standard bore) and type of luer connection (male luer slip, rotating male luer lock, and female luer lock) may be used to produce the gangs. The stopcock manifold gangs may also be marketed with a pre-attached backing plate which can be used to attach the stopcock gang to an IV pole.

This submission (K962581) is for a Stopcock Manifold Gangs, which is a medical device, not an AI/ML algorithm. Therefore, many of the requested categories related to AI/ML device studies and performance metrics (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set sample size, ground truth establishment) are not applicable.

The submission describes the device, its predicate devices, and the non-clinical tests performed to demonstrate its safety and effectiveness.

Here's a breakdown of the available information based on your request, with a clear indication of not applicable where appropriate for an AI/ML context:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable (N/A) for AI/ML context. This is a hardware medical device.
• For the device itself: The document does not specify exact sample sizes for each of the functional tests (e.g., how many stopcocks were tested for pressure seal). The testing was non-clinical (laboratory testing of the device components/assemblies). The "data provenance" would be internal laboratory testing by Baxter Healthcare Corporation in the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• N/A for AI/ML context. Ground truth in the AI sense is not applicable here.
• For the device itself: The "ground truth" for a physical device's performance is established by objective engineering standards and measurements. There wouldn't be "experts establishing ground truth" in the diagnostic sense, but rather engineers and quality control personnel performing and verifying the tests against established specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• N/A for AI/ML context. Adjudication methods are relevant for subjective interpretations of data, not for objective physical device testing.

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

• N/A. This is a physical medical device, not an AI-assisted diagnostic tool.

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

• N/A. This is a physical medical device, not an algorithm.

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

• N/A for AI/ML context.
• For the device itself: The "ground truth" for this device's performance is based on objective engineering specifications and standards (e.g., ANSI standard MD70.1-1983 for luer conformance, measurable flow rates, pressure resistance, and mechanical stability).

8. The sample size for the training set

• N/A. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

• N/A. This is a physical medical device; there is no training set or associated ground truth in the AI/ML sense.

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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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