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The addEASE 20 mm Binary Connector with 17 Ga. Needle is a double ended transfer device intended for use in a pharmacy setting to connect a B. Braun 250mL Excel® IV solution bag to a 20 mm drug vial for reconstituting or mixing the drug in the vial with the solution in the bag.

The addEASE 20 mm Binary Connector with 17 Ga. needle is a double ended transfer device intended to connect a B. Braun 250 mL Excel® IV solution bag to a 20 mm drug vial. The device contains a bag spike on one end and a vial spike on the other end. The vial spike is composed of polycarbonate and the bag spike is composed of a 17 Ga. stainless steel needle. The device contains a plunger which keeps the contents of the connected containers separate until the plunger is purposely deployed and the contents of the bag and vial are mixed. The bag spike and vial spike are protected with caps that maintain the sterility of the device until the caps are removed prior to use.

The provided documentation is a 510(k) Premarket Notification for the addEASE 20mm Binary Connector with 17 Ga. Needle. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical trial data or detailed performance metrics against specific acceptance criteria.

Therefore, the information required to fully answer your questions regarding acceptance criteria, study details, and ground truth establishment is not available within this document. This submission primarily focuses on the device's design, intended use, and its similarities to a previously cleared predicate device.

However, I can extract the available information and highlight what is missing:

1. Table of acceptance criteria and the reported device performance

The document states: "Design verification testing has been completed and all specifications have been met." However, the specific acceptance criteria and the detailed performance results are not provided in this summary.

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

The document mentions "Design verification testing," but does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information is not available in the provided text.

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

This information is not applicable as the document describes a device for transferring fluids, not an AI/diagnostic device that would typically involve expert-established ground truth. No experts for ground truth establishment are mentioned.

4. Adjudication method for the test set

This information is not applicable as the document describes a device for transferring fluids, not an AI/diagnostic device that would typically involve adjudication for ground truth.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

This information is not applicable as the document describes a device for transferring fluids, not an AI/diagnostic device that would typically involve MRMC studies.

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

This information is not applicable as the document describes a physical medical device, not an algorithm or AI system.

7. The type of ground truth used

This information is not applicable as the document describes a physical medical device. The "ground truth" for such a device would be based on engineering specifications, material properties, and functional testing rather than expert consensus or pathology.

8. The sample size for the training set

This information is not applicable as the document describes a physical medical device, not an AI/machine learning model that would require a training set.

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

This information is not applicable as the document describes a physical medical device.

Summary of the study conducted (as per the document):

The only study mentioned is "Design verification testing." The purpose of this testing was to demonstrate that the modified device (with the 17 Ga. needle) did not introduce new safety or effectiveness issues compared to the predicate device.

• Study Objective: To demonstrate that the addition of a 17 Ga. needle to the addEASE 20mm Binary Connector does not significantly impact the fundamental technology and does not raise new issues of safety or effectiveness compared to the predicate device (Add-A-Vial II, K900865).
• Methodology: "Design verification testing has been completed." The specific tests performed are not detailed, but would typically include tests related to mechanical integrity, sterility, leakage, function (e.g., successful transfer of fluids), and material compatibility.
• Results: "all specifications have been met." It further states that "The testing demonstrated that there are no differences between the predicate and the proposed device that raise new issues of safety or effectiveness."

In conclusion, this 510(k) summary provides evidence of design verification testing to support substantial equivalence but does not offer the detailed performance metrics, sample sizes, or ground truth methodologies that would be typical for an AI/ML-based device submission.

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