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The Vented Single Vial Access Device is a stand-alone, singleuse, disposable device which permits access to a medication vial without the use of a needle. The device is intended for use by healthcare professionals in a wide variety of healthcare environments, including hospitals, healthcare facilities, and pharmacies.

The Vented Single Vial Access Device is indicated for use with standard medication vials and mating luer access devices for withdrawal and/or injection of fluid.

The Vented Single Vial Access Device (ViaLokTM / Universal) is a sterile, stand-alone, single-use, disposable device which permits access to a medication vial without the use of a needle. These devices are inserted into a stopper of a medication vial. The healthcare provider uses the Vented Single Vial Access Device to transfer and mix drugs contained in standard medication vials. The Vented Single Vial Access Device includes three product configurations in this submission:

• ViaLok™ 20 mm Single Vial Access Device, Vented, Female Luer .
• . ViaLok™ 13 mm Single Vial Access Device, Vented, Female Luer
• . Universal Single Vial Access Device, Vented, Female Luer

The 20mm and 13mm product configurations are intended to mate with standard medication vial enclosure sizes (20mm and 13mm, respectively). The Universal device does not contain a shroud and can be used independent of enclosure size. Each Vented Single Vial Access Device configuration is offered with a female luer.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" with pass/fail values. Instead, it lists various performance tests conducted to demonstrate equivalency to predicate devices. The reported device performance for each test is generally stated as "meets all specified requirements" or "is as safe and effective as the legally marketed devices."

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each performance test. It only mentions that "samples of the predicate device were tested along with the Vented Single Vial Access Device" where performance data for a predicate was unavailable.

The data provenance is from Yukon Medical, LLC's internal testing as part of their 510(k) submission. It is a prospective study in the sense that the new device was manufactured and then subjected to these performance tests. The country of origin of the data is not specified, but the submission is to the US FDA, implying US regulatory standards and potentially US-based testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the device is a physical medical device (Vented Single Vial Access Device), not an AI/software-based diagnostic tool. Ground truth in this context refers to objective physical and chemical properties and performance, not expert interpretation of data. The "ground truth" is established by the specifications and standards for medical device performance.

4. Adjudication Method for the Test Set

This is not applicable for a physical medical device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human interpretation (e.g., of medical images) needs consensus. For device performance, the results are objectively measured against established standards.

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 is not applicable. An MRMC study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) use the AI to improve their performance. The Vented Single Vial Access Device is a physical, non-AI medical device.

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

This is not applicable. This question refers to the performance of an AI algorithm in isolation. The Vented Single Vial Access Device is a physical device.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests conducted on the Vented Single Vial Access Device is primarily based on:

• Established industry standards: Such as ISO 594-2 for luer connections and ISO 10993 series for biocompatibility.
• Performance characteristics of legally marketed predicate devices: The new device's performance is compared to that of existing, cleared predicate devices (Yukon Medical's ViaLok™ Non-vented and Medimop Medical Projects' Vented Vial Adapter Transfer Device). The implicit ground truth is that the predicate devices are safe and effective.
• Engineering specifications and design requirements: While not explicitly detailed in the summary, underlying the tests are specific engineering targets for flow rates, leak resistance, etc., which define acceptable performance.

8. The Sample Size for the Training Set

This is not applicable. A "training set" refers to data used to train an AI algorithm. The Vented Single Vial Access Device is a physical medical device and does not involve AI.

9. How the Ground Truth for the Training Set was Established

This is not applicable for the reasons stated in point 8.

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