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The 20mm SmartSite ™ Vented Vial Access Device is intended for use by healthcare professionals, patients, and/or caregivers in a wide variety of healthcare and home use environments for reconstitution or dispensing of medication. The SmartSite Vented Vial Access Device is indicated for use with standard 20 mm rubber-stopper medication vials for reconstitution or dispensing of medications.

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 vial spike, the vial retention shroud, a hydrophobic filter assembly and a SmartSite™ needle-free valve.

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 to 7 days.

The provided text is a 510(k) summary for the "SmartSite™ Vented Vial Access Device" and does not contain any information about a study proving the device meets specific acceptance criteria using a test set of medical images or other data that would involve ground truth established by experts.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (SmartSite® Vented Vial Access Device, K151963) through comparisons of intended use, design, technology, materials, and performance characteristics.

The "testing" mentioned in the document refers to engineering and biocompatibility tests for the physical device, not an AI/algorithm-based performance study. For example:

• Human Factors Engineering/Usability Engineering Study: This relates to how users interact with the physical device, not an algorithm's performance on data.
• Particulate Contamination Testing, Fragmentation Testing, Attachment force, Flow rate, Shelf life, etc.: These are physical performance tests of the device itself.
• Chemical Characterization Testing: Relates to the material properties of the device.
• Biocompatibility Testing: Relates to the device's interaction with the body (e.g., cytotoxicity, irritation).

Therefore, I cannot provide the requested information regarding acceptance criteria and study details as they pertain to an AI/algorithm-based device and its performance metrics against a ground truth. The document does not describe such a study.

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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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Churchill Medical Systems Mini Transfer Device is used for transferring and or dispensing medications, diluents and additives from rubber stoppered multi dose vials.

The Churchill Medical Systems Mini Transfer Device is a standard vented access device. It contains a universal piercing spike with female luer lock and .22 micron hydrophobic filter. The purpose of the filter within the spike body is to provide air-venting.

The provided text describes a 510(k) premarket notification for a medical device called the "Vented Vial Access Device" (also referred to as "Mini Transfer Device"). The document outlines the device's description, intended use, and a performance summary. However, it does not detail specific acceptance criteria or a comprehensive study report with quantitative results in the way a modern clinical trial or AI/software validation study would.

Instead, the performance summary focuses on compliance with established standards and comparison to a predicate device for the purpose of demonstrating "substantial equivalence" to obtain market clearance.

Here's an attempt to structure the information based on your request, highlighting what is available and what is not:

Acceptance Criteria and Study for the Churchill Medical Systems Mini Transfer Device (K013950)

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a typical clinical trial format (e.g., specific sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly defined by compliance with recognized standards and demonstration of substantial equivalence to a predicate device. The study described is a series of tests to ensure this compliance and equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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

The 510(k) summary does not specify the sample sizes used for the various tests (physical, chemical, biological, or functional comparison). It also does not mention the data provenance (e.g., country of origin, retrospective/prospective). The implication is that standard manufacturing and testing batches were used as per the mentioned ISO and USP standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable and therefore not provided in the 510(k) summary. For a device like a vial access device, "ground truth" is typically established by objective measurement against engineering specifications and validated test methods, rather than expert consensus on diagnostic images or clinical outcomes. The "experts" involved would be quality engineers, microbiologists, and other technical professionals conducting the tests, ensuring compliance with standards.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective measurements against established standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices or AI-driven systems where human interpretation is a key component and the goal is to show improvement with AI assistance. The Mini Transfer Device is a mechanical access device.

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

This concept is not applicable to this medical device. The device is a physical product, not a software algorithm that operates without human interaction.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• Compliance with international and national standards (e.g., ISO 10993-1, USP 24, ISO 11607-1, ISO 11135).
• Adherence to internal company specifications for physical and chemical properties.
• Performance comparison to a legally marketed predicate device (Baxter Healthcare Chemo-Aide Dispensing Pin), demonstrating "similar technical characteristics" and performance.

These are objective, measurable criteria related to the device's physical properties, biocompatibility, sterility, and functional operation (transferring/dispensing fluids) as designed.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or an "algorithm" in the sense that would require a training set.

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

Not applicable, as there is no training set for this device.

Summary Takeaway:

The K013950 510(k) summary demonstrates compliance and substantial equivalence through a series of tests against established industry standards and comparison to a predicate device. It does not provide detailed quantitative performance metrics or studies akin to those for AI/software devices or complex diagnostic tools. The focus is on ensuring the device meets safety and effectiveness requirements through adherence to manufacturing and testing protocols relevant to its classification as an IV administration set accessory.

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