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The Vial Adapter is indicated for the transfer of drugs contained in a vial.

The Vial Adapter (VA) 20mm is a single-use device that allows for the transfer of drugs contained in a vial. The device is a one-piece polycarbonate molded part with a standard female Luer port for the connection of a syringe. Puncturing the elastomeric closure of a drug vial is achieved by means of an integral plastic cannulated spike located in the center of the Vial Adapter component. The VA 20mm device is supplied with or without an inline filter, based on catalog number. The VA is sterilized utilizing gamma irradiation and is packaged in a Polyethylene Terephthalate Glycol (PETG) blister enclosure. The VA 20mm is packaged in either a Vial First (VF) or a Syringe First (SF) orientation. The device does not contain any medicinal substances or moving parts and is intended for use with standard drug vials having a neck diameter of 20mm.

The provided text describes a 510(k) premarket notification for a medical device called "Vial Adapter 20mm". This is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study designed to prove the device meets acceptance criteria in the typical academic or clinical trial sense.

Therefore, many of the requested categories (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable in this context, as they pertain to clinical or AI/algorithm performance studies. This document focuses on bench testing and regulatory comparisons.

Here's a breakdown of the information that can be extracted:

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

The document lists various performance tests conducted. For each test, the acceptance criteria are implicitly defined by the referenced standard or the success of the "in-house test method." The reported device performance is indicated by statements like "meets all applicable design and performance requirements," "conforms to applicable external and internal standards," and "successfully conducted." Specific numerical performance data or detailed results are not provided in this summary.

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: Not specified in the provided text.
• Data Provenance: The tests are "non-clinical performance data" and "bench performance tests." The manufacturing facility is in Ra'anana, Israel. The data would be prospective for the purpose of this submission (i.e., new testing done for this device).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This is not a study relying on expert interpretation for ground truth. It's an engineering and regulatory compliance submission based on physical and chemical testing.

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

• Not Applicable. No human adjudication of results is described for these bench tests; results are objective measurements against 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

• Not Applicable. This device is a passive, non-electrical, non-software-enabled mechanical component (Vial Adapter), not an AI or imaging device that would involve human readers or AI assistance.

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

• Not Applicable. As mentioned above, this is a mechanical medical device, not an algorithm.

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

• The "ground truth" for the performance tests outlined is defined by the specified international and in-house standards (e.g., ISO, USP, ASTM) that the device must comply with. For biocompatibility and sterilization, it's compliance with safety thresholds and validation standards.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning study, 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 irrelevant.

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