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The HLIC Needle-Less Valve is intended to allow access to IV administration sets, medication vials, blood donor collection bags, and solution bags with one convenient device without the use of needles or blunt cannulas.

The HLIC Needle-Less Valve is a needle free valve that allows the user to add medication into IV sets without the use of a needle. When the valve is in the closed position, it has a flat, smooth surface for cleaning. When the male connector of a syringe or secondary line is pushed into the valve, the silicone stem opens in the middle creating a fluid path. When the male connector is removed from the valve, the body of the valve forces the stem shut and maintains a sealed fluid path. A cap is not required to seal the valve or to maintain sterility.

The provided text describes a 510(k) Premarket Notification for the HLIC Needle-Less Valve, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical studies to establish diagnostic performance against specific acceptance criteria like those common for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not directly applicable to this SSEA (Summary of Safety and Effectiveness Analysis) for a non-diagnostic, non-AI medical device.

However, I can extract the relevant information pertaining to the device's performance testing and the conclusion regarding its safety and effectiveness.

Here's a breakdown based on the provided text, indicating where information is not available or not applicable for this type of device submission:

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

The document states that the device "met all established acceptance criteria for performance testing and design verification testing." While the specific acceptance criteria are not detailed in this public summary, the device passed them.

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

• Sample Size for Test Set: Not specified in the provided summary. Performance and design verification testing typically involve various sample sizes depending on the specific test (e.g., flow rates, pressure resistance, sterility, biocompatibility).
• Data Provenance: The testing was conducted by Health Line International Corporation, located in Centerville, Utah, USA. The summary does not specify whether the data was retrospective or prospective, but performance verification testing is inherently prospective, as it involves newly manufactured devices undergoing specific tests.

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 to this type of device. The HLIC Needle-Less Valve is a physical medical device (an intravascular administration set component), not a diagnostic tool where "ground truth" is established by expert interpretation of medical images or data. Performance is assessed through engineering and biocompatibility tests against predefined metrics.

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

This question is not applicable to this type of device. Adjudication methods like 2+1 or 3+1 are used in studies where there is subjective interpretation (e.g., by human readers of medical images) that requires resolution in case of disagreement. The performance tests for this device involve objective measurements.

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

This question is not applicable to this type of device. MRMC studies, especially those involving AI assistance, are relevant for diagnostic devices that impact human interpretation. The HLIC Needle-Less Valve is a mechanical component, not an AI/ML diagnostic tool.

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

This question is not applicable to this type of device. Standalone algorithm performance is relevant for AI/ML devices. The HLIC Needle-Less Valve does not have an algorithm. Its performance is assessed through its physical characteristics and functionality.

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

This question is not applicable in the traditional sense for this device. The "ground truth" for this device's performance is established by engineering specifications, regulatory standards (e.g., ISO-10993), and industry best practices for mechanical and material properties (e.g., flow rates, leak integrity, pressure resistance, biocompatibility). It is an objective standard rather than an expert interpretation.

8. The sample size for the training set

This question is not applicable to this type of device. "Training sets" are used for AI/ML models. This device is a physical medical component, not an AI model.

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

This question is not applicable to this type of device, as there is no "training set" in the context of an AI/ML model for this product.

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