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The NEXUS™ MIDLINE CT CATHETER is indicated for short term (less than 30 days) peripheral access to the peripheral venous system for infusion, intravenous therapy and blood sampling. The NEXUS™ MIDLINE CT CATHETER is suitable for use with power injectors.

The NEXUS™ MIDLINE CT Catheter is a family of peripherally inserted central catheters made from specially formulated biocompatible medical grade materials. Catheters are packaged in a tray with accessories necessary for a percutaneous microintroducer introduction (Modified Seldinger or Seldinger technique). The device is intended for short term (less than 30days) vascular access. The NEXUS™ MIDLINE CT Catheter is indicated for dwell times shorter than 30 days. The NEXUS™ MIDLINE CT Catheter product line will have catheters in 3Fr, 4 Fr and 5 Fr single lumen, and 4 Fr and 5 Fr dual lumen. The NEXUS™ MIDLINE CT Catheters are supplied in two lengths, approximately 10 and 20 cm long. All catheters are attached to an injectionmolded polyurethane hub that has extension legs with Luer lock fittings for access attachment.

The provided text describes the Nexus Midline CT Catheter and its substantial equivalence to predicate devices, but it does not contain details of a clinical study or a multi-reader multi-case (MRMC) comparative effectiveness study. The information focuses on non-clinical bench testing to demonstrate performance and substantial equivalence.

Here's an analysis based on the provided text, addressing the points where information is available and indicating where it is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that various bench tests "met predefined acceptance criteria" and "demonstrated equivalence." However, it does not provide the specific numerical acceptance criteria or the numerical reported device performance for each test. It only lists the tests performed and states they were successful.

A qualitative summary of the performance claims based on the text:

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

• Sample Size for Test Set: The document does not specify the sample size for any of the bench tests (e.g., number of catheters tested for tensile strength, burst pressure, etc.).
• Data Provenance: The data is described as "Nonclinical tests" and "bench test data" performed for "design verification testing." This suggests it's laboratory-based testing of the device itself, not data from human subjects or clinical settings. There is no mention of country of origin as it pertains to clinical data, as this is bench testing. The data is not described as retrospective or prospective clinical data.

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

This question is not applicable as the document describes non-clinical bench testing. There is no mention of human experts being involved in establishing "ground truth" for these engineering and material performance tests. The "ground truth" for such tests would typically be defined by engineering specifications and direct physical measurements.

4. Adjudication method for the test set

This question is not applicable as the document describes non-clinical bench testing. Adjudication methods like 2+1 or 3+1 typically refer to expert consensus in interpreting images or clinical outcomes, which is not relevant here.

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

No MRMC comparative effectiveness study was done or mentioned. The submission describes non-clinical bench testing for a physical medical device (catheter), not an AI algorithm or a diagnostic tool that would involve human readers.

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

No standalone algorithm performance study was done or mentioned. The device is a physical catheter, not a software algorithm.

7. The type of ground truth used

For the non-clinical bench testing, the "ground truth" refers to engineering specifications, direct physical measurements, and adherence to relevant international standards (e.g., ISO 11135:2007 for sterilization, ISO-10993 for biocompatibility). The document states that testing was performed "according to protocols based on the above-referenced guidance document recommendations and additional standards."

8. The sample size for the training set

This question is not applicable as the document describes non-clinical bench testing for a physical medical device. There is no mention of a "training set" in the context of an algorithm.

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

This question is not applicable for the same reason as point 8.

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