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For use in neonatal population only. To be used with an indwelling catheter for the administration or withdrawal of fluids. This device may aid in the prevention of needlestick injuries.

The Interlink T-Connector Extension Set consists of an Interlink injection site integrated into a T-Housing on one end of the extension set with a female adapter connected to the other end. A slide clamp is also included on the tubing. This extension set is connected to an indwelling catheter in order to administer or withdraw fluids. The injection site is accessed by a blunt plastic cannula; this allows fluid flow while aiding in the prevention of needlestick injuries.

The provided text describes a 510(k) premarket notification for a medical device, the Interlink T-Connector Extension Set. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable metrics.

Therefore, many of the requested sections (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, etc.) cannot be definitively answered based on the provided document. The document states that testing was performed and met acceptance criteria, but it does not elaborate on the specifics of those criteria or the study methodology.

Below is an attempt to extract and present the information that is available, with clear indications where the requested information is absent from the provided text.

Acceptance Criteria and Device Performance Study Summary

The provided document describes a 510(k) premarket notification for the Interlink T-Connector Extension Set. The primary goal of this submission is to demonstrate substantial equivalence to a legally marketed predicate device (Baxter Interlink T-Connector Extension Set cleared under K921899).

The document does not provide a specific table of acceptance criteria with reported numerical device performance values or a detailed study report that quantitatively proves the device meets those criteria. Instead, it makes a general statement that:

"All test results met the acceptance criteria."

The "Discussion of Nonclinical Tests" section broadly outlines the types of testing performed:

• Risk Analysis: Conducted using procedures based on ISO 14971 (2000) "Medical Devices - Application of Risk Management to Medical Devices." The method used was Failure Modes and Effects Analysis (FMEA).
• Design Verification Tests: Performed based on the results of risk analysis and design input.
• Specific Tests Included: Mechanical, biocompatibility, and microbial ingress testing.

The acceptance criteria for these tests are not detailed, nor are the specific numerical results. The document concludes that "The Interlink T-Connector Extension Set is substantially equivalent to the currently cleared Interlink T-Connector Extension Set."

1. Table of Acceptance Criteria and the Reported Device Performance

Note: The document states "All test results met the acceptance criteria" but does not provide the specific quantitative acceptance criteria or detailed numerical performance results for each test. This table summarizes the categories of testing mentioned.

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

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: The testing was conducted by Baxter Healthcare Corporation. The location (e.g., country of origin) of the testing is not explicitly stated, but the company is based in Deerfield, Illinois, USA. The study design is not detailed enough to determine if it was retrospective or prospective, but typically design verification testing done for a 510(k) submission is prospective.

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

• Not Applicable. This device is an IV administration set, not an AI/imaging diagnostic device that would typically involve experts establishing ground truth for a test set. The efficacy and safety are determined through physical, chemical, and biological testing, not expert interpretation of outputs.

4. Adjudication method for the test set

• Not Applicable. As this is not a diagnostic device requiring expert interpretation or consensus, there is no adjudication method described.

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. This is not an AI-assisted diagnostic device, so an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

• Not Applicable. This is a physical medical device (IV administration set), not a software algorithm. Therefore, "standalone algorithm performance" as typically understood in AI/software domains is not relevant.

7. The type of ground truth used

• The "ground truth" for the non-clinical tests (mechanical, biocompatibility, microbial ingress) would be established by validated laboratory test methods and established standards (e.g., ISO standards for biocompatibility, sterility testing protocols, or internal material specifications for mechanical properties). The document mentions ISO 14971 for risk management.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not a machine learning model, 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, this question is not relevant.

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