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The Vial2Bag™ Direct Connect is indicated to serve as a connecting part between the IV bag and an external IV line. The integrated vial adapter makes it possible to reconstitute and admix drugs from a vial into the infusion solution.

The proposed device, Vial2Bag Direct Connect, 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. Vial2Bag Direct Connect is available with 13mm Vial Adapter or 20mm Vial Adapter. The device consists of the Vial2Bag piercing spike and cover, the twist-off connector and an integrated Vial Adapter (13mm or 20mm) for access to the drug/solution vial.

Up to 3 Vial2Bag Direct Connect can be consecutively connected by inserting the spike of one device into the twist off connector of the previous device.

The device does not contain any medicinal substances, and can be used with standard drug vials.

This is a 510(k) premarket notification for a medical device (Vial2Bag™ Direct Connect), not an AI/ML device. Therefore, the requested information regarding AI/ML device acceptance criteria and study details is not applicable to this document. The document describes modifications to an existing device and the performance testing conducted to ensure substantial equivalence to a predicate device.

However, I can extract information related to the device's performance testing and general characteristics from the provided text.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests conducted, but it does not explicitly define specific numerical acceptance criteria for each test. Instead, it states for all tests: "All testing met the required acceptance criteria." This implies that internal, pre-defined acceptance criteria were used and successfully achieved.

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

The document does not specify the exact sample sizes used for each performance test. It only states that "The modifications to the proposed device were evaluated within the Medimop design control system." The data provenance is internal to Medimop Medical Project Ltd., based in Israel. The studies are prospective in the sense that they were conducted specifically for this 510(k) submission to evaluate the modified device.

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

This information is not applicable. The device is a physical medical device, not an AI/ML product that requires expert-established ground truth for performance evaluation in the context of image interpretation or diagnosis. The "ground truth" for the performance tests would be defined by engineering specifications and relevant regulatory standards.

4. Adjudication Method for the Test Set:

Not applicable for a physical device's performance testing. The tests are typically objective measurements against predefined criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is a physical device, not an AI/ML diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This is a physical device, not an AI/ML algorithm.

7. Type of Ground Truth Used:

For the performance tests, the "ground truth" is a combination of:

• Internal performance standards: Defined by the manufacturer (Medimop) for functionality, penetration force, detachment forces, torque, ductility, and air leakage.
• International Standards: e.g., ISO 11607-1 for packaging, ISO 11135-1:2007 for sterilization, ISO 10993-7:2008 for ETO and ECH residuals, ISO 10993-1 and G95-1 for biocompatibility assessment, and specific ISO 10993 sub-standards, ASTM F756, and USP 151 for various biocompatibility tests.
• Regulatory requirements: e.g., acceptable Endotoxin levels.

8. Sample Size for the Training Set:

Not applicable. This is a physical device, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

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The Vial2Bag™ Direct Connect is indicated to serve as a connecting part between the IV line. The integrated vial adapter makes it possible to reconstitute and admix drugs from a vial into the infusion solution.

The proposed device, Vial2Bag" Direct Connect, consists of the Vial2Bag" piercing spike and cover, the twist-off connector and an integrated Vial Adapter for access to the drug/solution vial. It does not contain any medicinal substances and can be used with standard drug vials. It is intended for use in healthcare facilities or in home environment by a care-giver to aid and support prescribed treatment and therapy.

The provided text describes the 510(k) summary for the Vial2Bag™ Direct Connect device, focusing on its substantial equivalence to predicate devices based on performance testing and biocompatibility assessments. Here's a breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All bench testing was performed following double EtO sterilization to ensure that the sterilization process does not have a detrimental effect on the proposed device, Vial2Bag™ Direct Connect performance. The following tests were completed and all of them passed the established acceptance criteria." However, it does not explicitly list the specific quantitative acceptance criteria for each test. It simply states that they "passed."

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

The document does not specify the sample sizes used for each of the performance and biocompatibility tests. It also does not explicitly state the provenance of the data (e.g., country of origin, retrospective or prospective), but it can be inferred that the testing was conducted by or on behalf of Medimop Medical Projects Ltd. in Israel, as they are the company proposing the device. These tests are typically prospective, meaning they are designed and executed specifically for regulatory submission.

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

This information is not applicable and not provided in the context of device performance and biocompatibility testing for this type of medical device (IV administration set). "Ground truth" and expert consensus typically apply to diagnostic or AI-driven devices where human interpretation or a gold standard diagnosis is compared against the device's output. Here, the tests are objective, laboratory-based measurements against pre-defined engineering and biological safety standards.

4. Adjudication Method for the Test Set

This information is not applicable for this type of device testing. Adjudication methods like 2+1 or 3+1 typically relate to conflicting expert opinions in diagnostic studies, which is not relevant here. The evaluation of test results against acceptance criteria is usually a straightforward pass/fail assessment.

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

An MRMC study is not applicable and was not performed or mentioned for the Vial2Bag™ Direct Connect device. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of medical images or data, often in conjunction with AI. The Vial2Bag™ Direct Connect is an IV administration set and does not involve "readers" or AI assistance in this context.

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

This is not applicable. The Vial2Bag™ Direct Connect is a physical medical device, not an algorithm or software. Therefore, there is no "standalone algorithm" performance to report.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the performance tests, the "ground truth" is defined by established engineering specifications and physical properties that the device must meet, often based on recognized standards (e.g., ISO for biocompatibility). For biocompatibility, the ground truth is the biological response observed in standardized in vitro and in vivo animal models compared against internationally recognized safety thresholds. There is no expert consensus, pathology, or outcomes data used as "ground truth" in the way it would be for a diagnostic tool.

8. The Sample Size for the Training Set

This is not applicable. The Vial2Bag™ Direct Connect is a physical medical device. It does not employ machine learning or AI, and therefore does not have a "training set" in the computational sense.

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

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

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