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The SmartSite® Vented Vial Access Device is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® Vented Vial Access Device is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.

The 20mm SmartSite® Vented Vial Access Device is a stand alone, sterile, single-use, disposable device which permits access to a medication vial without the use of a needle. It consists of a spike, locking shroud, hydrophobic filter, and SmartSite® needle-free access valve for Luer access.

The SmartSite® Vented Vial Access Device is microbiologically closed. When used in a USP compliant pharmaceutical compounding and storage environment, the SmartSite® Vented Vial Access Device is capable of maintaining the sterility of vial medications for up to7 days.

This document is a 510(k) summary for the SmartSite® Vented Vial Access Device, which is a medical device for accessing medication vials. The summary primarily focuses on demonstrating substantial equivalence to a predicate device and does not involve AI/ML performance evaluation. Therefore, many of the requested categories related to AI/ML studies are not applicable.

Here's the information extracted and categorized based on your request, with "Not Applicable" for sections where the document does not provide the requested AI/ML related details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" against which a device's AI/ML performance is measured, as this is a traditional medical device submission, not an AI/ML one. However, it lists various tests performed to demonstrate the device's functional and safety characteristics, primarily against a predicate device.

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

Not Applicable (This is a traditional medical device; no "test set" in the context of AI/ML data). The document refers to "tests conducted" on the device itself and the predicate device. The specific sample sizes for these engineering and biological tests are not detailed in this summary. Data provenance is not described as it relates to physical device testing rather than clinical data.

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

Not Applicable (No AI/ML system involved in a clinical study to establish ground truth).

4. Adjudication method for the test set

Not Applicable (No AI/ML system involved in a clinical study requiring adjudication).

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 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 (No AI/ML algorithm involved).

7. The type of ground truth used

Not Applicable (No AI/ML system requiring a ground truth in the context of expert consensus, pathology, or outcomes data). The "ground truth" for this device would be its adherence to established engineering, safety, and performance specifications as measured by laboratory testing and previous FDA clearances for its components.

8. The sample size for the training set

Not Applicable (No AI/ML model with a training set).

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

Not Applicable (No AI/ML model with a training set).

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The SmartSite® Vented Vial Access Device is intended for use by healthcarc professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies for reconstitution or dispensing of medication. The SmartSite® Vented Vial Access Device is indicated for use with rubber-stopper medication vials for reconstitution or dispensing of medications, including chemotherapy agents.

The SmartSite® Vented Vial Access Device (Vented VAD) is a stand-alone, single use, multiple-dose device with a SmartSite® Needle Free Valve and a 0.2 micron hydrophobic air-venting filter for use with rubber-stopper vials. The device is intended for use when reconstituting Ivophilized drugs and/or when dispensing medications, particularly hazardous drugs such as chemotherapeuties.

I am sorry, but the provided text does not contain specific acceptance criteria or details of a study that proves the device meets such criteria. The document is a 510(k) summary for the SmartSite® Vented Vial Access Device, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than reporting on specific performance studies with detailed acceptance criteria.

While it mentions "performance data indicate that the SmartSite® Vented Vial Access Device meets specified requirements and is substantially equivalent to the predicate devices," it does not elaborate on what those specific requirements or the performance data entail. Therefore, I cannot extract the information required for your request.

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