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The Vented Vial Adapter Transfer Device is intended for the transfer and mixing of drugs contained in a vial.

The proposed device, Vented Vial Adapter Transfer Device - 13mm, is intended for use in healthcare facilities or in home environment by the patient or care-giver to aid and support prescribed treatment and therapy. The proposed device consists of two integrated parts, the 13mm vial adapter body intended to be attached to a standard 13 mm drug vial. The other end is intended to be connected to a Female Luer connection. The vial adapter body contains the dual lumen piercing spike and the second part of the device is an assembled 0.2um hydrophobic air path filter (100% expanded PTFE membrane over Non-woven polyester membrane support). This enables keeping an equilibrium pressure between the drug vial and the ambient pressure, filtering the inserted/ released air through 0.2um air filter. The proposed device does not contain any medicinal substances.

The provided text describes a 510(k) premarket notification for a medical device called the "Vented Vial Adapter Transfer Device - 13mm". The document focuses on demonstrating substantial equivalence to a predicate device (Vented Vial Adapter Transfer Device, K062482) through design comparisons and performance testing.

Here's an analysis of the acceptance criteria and the study as described in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that all testing met the required acceptance criteria, but it does not explicitly list specific numerical or qualitative acceptance criteria for each test. Instead, it lists the types of tests performed and generally states that the results met internal performance standards.

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

The document does not specify the sample sizes used for any of the performance tests. It also does not provide information on the data provenance (e.g., country of origin of the data, retrospective or prospective); it's implied the testing was conducted internally by Medimop Medical Projects Ltd. as part of their design control.

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

This information is not applicable to this type of device and study. The testing described is strictly focused on the physical and functional performance of a medical device (vial adapter), not on clinical diagnostic accuracy or interpretation by experts. Ground truth, in this context, refers to objective measurements and adherence to engineering and biocompatibility standards.

4. Adjudication Method for the Test Set

This information is not applicable to this type of device and study. Adjudication methods (like 2+1, 3+1) are typically used in studies involving expert reviews or clinical outcomes where there might be disagreements in interpretation. The performance tests for this device involve objective measurements against predefined standards.

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

No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers evaluating cases, often with and without AI assistance, to assess diagnostic performance. The device here is a physical product for drug transfer, not an AI-powered diagnostic tool.

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

This information is not applicable as the device is a physical, mechanical medical device and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used for the performance testing is based on internal performance standards and harmonized international standards (e.g., ISO 10993-1 for biocompatibility). For physical and functional tests, the ground truth would be precise measurements and observations confirming adherence to specified design parameters and functional requirements. For biocompatibility, the ground truth is conformance to the criteria outlined in ISO 10993-1.

8. The Sample Size for the Training Set

This information is not applicable. The device is not an AI/ML algorithm that requires training data.

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

This information is not applicable. As stated above, the device does not involve a training set.

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The Vented Vial Adapter Transfer Device is intended for the transfer and mixing of drugs contained in vials.

The Vented Vial Adapter Transfer Device is designed for the purpose of allowing safe and easy transfer of liquid drugs from and into vials while keeping the process in pressure equilibrium with the ambient pressure. The product allows quick transfer of the contents of a syringe, typically containing diluents, into a drug (in the form of powder) vial and easy aspiration of the dissolved drug back into a syringe, or any other standard accessory.

The Vented Vial Adapter Transfer Device is an assembly of three components. A Hydrophobic medium (optional) is attached to the "body" with the double lumen spike (penetrating the rubber stopper) and a cap (with a lucr connection) is attached to the subassembly.

The provided text describes a 510(k) submission for a medical device called the "Vented Vial Adapter Transfer Device." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study related to strict acceptance criteria and performance metrics in the way one might for a diagnostic AI device.

Therefore, many of the requested categories for AI device studies (e.g., sample size, expert qualifications, adjudication, MRMC studies, standalone performance) are not applicable to this type of medical device submission.

Here's an adaptation of the requested information based on the provided document:

Acceptance Criteria and Device Performance for the Vented Vial Adapter Transfer Device

The "acceptance criteria" for this device, within the context of a 510(k) submission, are primarily focused on demonstrating substantial equivalence to already cleared predicate devices regarding its intended use, technological characteristics, and safety and effectiveness. The "study" proving this largely relies on comparisons, material testing, and manufacturing quality controls.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable (N/A): This submission is for a medical device, not an AI/diagnostic software. There isn't a "test set" in the sense of a dataset for algorithm evaluation. Instead, the "testing" refers to manufacturing quality control and material biocompatibility.
• Data Provenance: The device is manufactured by Medimop Medical Projects Ltd. in Ra'anana, Israel. The material testing (ISO 10993-1 and USP V1) would generate data, but specific details on the provenance of these material tests beyond the standards themselves are not provided. The comparison is retrospective to existing predicate devices.

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

• N/A: Not relevant for this type of device submission. Ground truth as typically understood for AI models is not established.

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

• N/A: Not relevant for this type of device submission.

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

• N/A: Not relevant for this type of device submission. This is a physical medical device.

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

• N/A: Not relevant for this type of device submission.

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

• N/A (Indirectly): The "ground truth" for this type of device is implicitly the established safety and effectiveness of its predicate devices, as well as adherence to recognized material and manufacturing standards (ISO 10993-1, USP V1, internal release specifications). The FDA's substantial equivalence determination acts as the validation.

8. The sample size for the training set

• N/A: Not relevant for this type of device submission.

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

• N/A: Not relevant for this type of device submission.

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