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The MED-RX® Patient Delivery Set is to be used in the injection of contrast agents and flushing solutions for the purpose of enhancing diagnostic images.

The MED-RX® Patient Delivery Sets each consist of a male luer lock, two female luer locks, 3 tubing pieces, and either a dual check valve, a single check valve, or a Y-connector. The tube is made of polyvinyl chloride (PVC). The total length of the sets varies from 18″ to 86″ and is also available in a coiled configuration. The MED-RX® Patient Delivery Sets are provided sterile and are not to be resterilized.

This document describes the design and testing of a medical device, the MED-RX® Patient Delivery Set, but does not describe an AI/ML device. The information requested, particularly regarding acceptance criteria and studies proving the device meets those criteria, is typically provided for AI/ML devices to demonstrate their performance against defined metrics and ground truth.

Therefore, I cannot provide the requested information in the format of acceptance criteria and a study that proves the device meets those criteria from the provided text, as it pertains to a physical medical device and not an AI/ML system.

However, I can extract the non-clinical test summary which details performance tests:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Test Summary)

Regarding the specific questions about AI/ML device studies:

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

• This is not an AI/ML device; therefore, no test set of data (e.g., images, patient records) is described. The "samples" referred to in the non-clinical tests are physical units of the device.

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)

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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 as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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

• For the physical device, the "ground truth" is established by compliance with the specified international and internal standards (e.g., ISO, ASTM, USP) for physical and biological characteristics.

8. The sample size for the training set

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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The MED-RX Extension Set with T-Connector is intended to be used for administration or withdrawal of fluids to or from a neonatal patient as directed by a physician.

The MED-RX Extension Set with T-Connector is offered in two configurations, identical except for the tubing length. The proximal end of the MED-RX Extension Set with T-Connector features a T-Connector with an injection port and an integral rotating male luer lock. The distal end has a female luer lock fitting. The inner and outer diameter of both devices is consistent at 0.040" and 0.095" respectively, while the lengths available are either 4" or 38". Each of the luer fittings (distal female luer lock and proximal rotating male luer lock) are provided with protective caps. The MED-RX Extension Set with T-Connector is provided sterile and is single use.

This document describes the premarket notification for the "MED-RX Extension Set with T-Connector." The provided text focuses on demonstrating substantial equivalence to a predicate device and does not involve AI or algorithms, human readers, or image analysis. Therefore, many of the requested categories related to AI performance are not applicable.

Here's an analysis of the provided information based on the request:

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 exact sample sizes (number of units) used for each non-clinical test. The data provenance is internal testing performed by Benlan Inc., as part of their 510(k) submission to the FDA. This is likely retrospective testing for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a medical device in vitro testing, not an AI or diagnostic tool requiring expert ground truth for interpretation.

4. Adjudication method for the test set
Not applicable. This is not a study involving human interpretation or AI output that would require 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 a medical device (extension set) that does not involve AI or human readers for diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (extension set) and does not involve an algorithm.

7. The type of ground truth used
The "ground truth" for the performance tests is established by the specified ISO, ANSI/AAMI, ASTM, and USP standards. These standards define the acceptable physical, chemical, and biological properties of the device.

8. The sample size for the training set
Not applicable. This is not an AI/machine learning study, so there is no training set.

9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/machine learning model, no ground truth was established for it.

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