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The Baxter Neutral Luer Activated Device is intended for single patient use with a vascular access device for the administration of drugs and solutions without needles, thus eliminating the potential for needle-stick injuries during use. This device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids. This device may be used with low pressure power injectors having a maximum pressure of 325 psi (2241 kPa) and a maximum flow rate of 10 mL/s.

The Neutral Luer Activated Device (LAD) and Extension Sets with Neutral Luer Activated Device are single use disposable devices intended for use with a vascular access device for continuous or intermittent fluid administration or withdrawal of fluids. The device is an in-line access site and can be connected to male Luer adapters (e.g., syringes or sets) to allow needleless access to the fluid or vascular path and is designed to be easy to swab. A saline flush of 10 mL is able to clear the Neutral LAD of blood after sampling blood through the device. The Neutral LAD is clear and allows the clinician to view the fluid path of the device. The Neutral LAD has a low priming volume (0.08 mL) that allows medication to be flushed from the device with small amounts of fluid and is the maximum amount of medication that could potentially remain in the device when administered to a patient prior to flushing. A LAD with a low priming/residual volume is favored for pediatric patients or patients requiring fluid restriction. The device is a neutral fluid displacement LAD and does not require a specific clamping sequence in order to be used safely. This neutral displacement design has the added benefit of helping to reduce the occurrence of thrombotic catheter occlusions by limiting the reflux of blood into the catheter. The Neutral LAD may be used with low pressure power injectors having a maximum pressure of 325 psi (2241 kPa) and a maximum flow rate of 10 mL/s.

This 510(k) premarket notification describes a medical device, specifically the "Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated Device," not an AI/ML powered device. As such, the requested information regarding AI/ML study components (such as sample size for test/training sets, ground truth methodology, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable and cannot be extracted from the provided text.

The document focuses on demonstrating the substantial equivalence of the new device to existing predicate devices through non-clinical testing.

Here's the relevant information that can be extracted regarding acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable. This is a physical medical device, not an AI/ML algorithm requiring a data test set for performance evaluation in the context of an algorithm's output. The "testing" refers to benchtop or in-vitro tests on the devices themselves.
• The provenance of data refers to the specific non-clinical tests performed (e.g., pressure testing, flow rate testing, biocompatibility testing, microbial ingress testing, etc.). These are typically laboratory-based tests and not patient data.

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

• Not applicable. As this is a physical device, ground truth is established through adherence to engineering specifications, validated test methods, and regulatory standards for device performance, sterility, and biocompatibility. There is no concept of "expert ground truth" in the way it is used for diagnostic AI.

4. Adjudication method for the test set:

• Not applicable. There is no "test set" in the context of human interpretation needing adjudication for an AI algorithm. Device performance is evaluated against predefined pass/fail criteria in laboratory settings.

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 physical medical device, not an AI/ML diagnostic or assistive tool.

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

• Not applicable. This is a physical medical device, not an AI/ML algorithm.

7. The type of ground truth used:

• Engineering specifications and regulatory standards. For example, pressure testing would have a ground truth defined by a specific pressure range (e.g., 325 psi maximum), and the device either meets or fails this. Biocompatibility would be determined by established ISO standards. Microbial ingress would have a ground truth of preventing microbial contamination.

8. The sample size for the training set:

• Not applicable. 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:

• Not applicable. This is a physical medical device, not an AI/ML algorithm.

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