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The Vial2Bag Advanced® 20mm Admixture Device is indicated to serve as a connection between a 50, 100 or 250mL IV bag, vial with 20mm closure, and an external IV administration set. The integrated Vial Adapter makes it possible to reconstitute and/or admix drugs prior to administration to the patient. Indicated for adolescent and adult patients only.

The Vial2Bag Advanced® 20mm Admixture Device is a single-use, sterile, needle-less, nonpyrogenic, fluid transfer device that allows for reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution, through the IV bag administration port. The device consists of the body, Protector, IV Port, and an integrated vial adapter. The device is intended to be used with standard drug vials with a 20mm closure and an elastomeric stopper. The Vial2Bag Advanced® 20mm device is designed to work with a standard 50, 100, or 250mL IV bag and an external IV infusion set.

The provided text describes a medical device, the Vial2Bag Advanced® 20mm Admixture Device, and its comparison to a predicate device for substantial equivalence. It is not an AI/ML device, therefore, many of the requested fields are not applicable.

Here's an analysis based on the information provided:

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

The document outlines performance testing, but the explicit acceptance criteria are not tabulated with specific performance results. Instead, it states that testing was conducted to ensure the device "met the applicable design and performance requirements." For some tests, it mentions the basis for acceptance criteria or sample size, but not the actual criteria set.

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

• Sample Size for Fragmentation Test: "sample size based on EN ISO 7864, Annex B, Section B.4." (Specific number not provided, but the standard is cited.)
• Sample Size for other tests: Not explicitly stated.
• Data Provenance: The tests are in-house, suggesting they were conducted by the manufacturer, West Pharma. Services IL, Ltd., in Ra'anana, Israel. There is no mention of retrospective or prospective data in the context of performance testing on the device itself.

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

This is not applicable as the device is a physical medical device (fluid transfer device) and not an AI/ML diagnostic or predictive tool that requires expert-established ground truth on a test set. The performance testing is based on engineering and material standards.

4. Adjudication method for the test set:

Not applicable for a physical device's performance testing. The outcomes of the tests are objective measurements against established standards or in-house criteria.

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 is not an AI/ML device, and no MRMC study was conducted or is relevant.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

The performance criteria are established through:

• In-house test methods (presumably based on engineering principles and intended function).
• International standards (e.g., EN ISO 8536-2 for Fragmentation, ISO 10993-1 for Biocompatibility).
• Comparison to a predicate device to demonstrate "substantial equivalence."

8. The 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 Advanced® 13mm Admixture Device is indicated to serve as a connection between a 50, 100 or 250mL V bag, vial with 13mm closure, and an external IV administration set. The integrated Vial Adapter makes it possible to reconstitute and/or admix drugs prior to administration to the patient. Indicated for adolescent and adult patients only.

The Vial2Bag Advanced® 13mm Admixture Device is a single use, fluid transfer device that allows for reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution, through the IV bag administration port. The device consists of the body, Protector, IV Port, and an integrated vial adapter. The device is provided as a sterile, nonpyrogenic product. The device is intended to be used with standard drug vials with a seal diameter of 13mm and an elastomeric stopper. The Vial2Bag Advanced® 13mm device is designed to work with a standard 50, 100, or 250mL IV bag and an external IV infusion set. Users should not attach a Vial2Bag Advanced device to another Vial2Bag Advanced Device. The device does not contain any medicinal substances and there are no additional accessories needed or provided with the Vial2Bag Advanced 13mm Device for the device to meet its intended purpose.

This document is a 510(k) Premarket Notification for a medical device (Vial2Bag Advanced® 13mm Admixture Device) and does not describe an AI/ML powered device. Therefore, many of the requested criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," and "standalone (algorithm only) performance," are not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing, chemical tests, biocompatibility testing, sterilization validation, and a human factors study.

Here's the breakdown of the information provided in the document based on your request, with a clear indication of what is not applicable due to the nature of the device:

Device Reviewed: Vial2Bag Advanced® 13mm Admixture Device

Overall Conclusion: The device is deemed substantially equivalent to a predicate device (Vial2Bag Advanced 20mm Admixture Device, K201415), based on non-clinical performance data, chemical tests, biocompatibility tests, sterilization, and human factors study results. It is not an AI/ML device, thus direct AI-specific performance metrics are not available.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a direct "acceptance criteria" table with performance results in a single, concise format for each test. Instead, it lists the types of tests performed and states that the device "met the applicable design and performance requirements." For each test, the acceptance criteria are implicitly those defined by the referenced standards (e.g., ISO-8536-4, USP , EN ISO 8536-2, ISO 10993 series) or the in-house test methods mentioned. The performance is reported as meeting these requirements.

Here's a summary of the types of tests and the general reported performance:

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

• Sample Size for Test Set: The document explicitly mentions:
  • For Fragmentation and Coring tests: "sample size based on EN ISO 7864, Annex B. Section B.4." (Specific number not provided in this document, but directed to the standard).
  • For other performance tests, chemical tests, and biocompatibility, specific sample sizes are not detailed in this summary, but would be part of the underlying test reports.
  • For the Human Factors Validation Study: "recruited nurses, physicians, and pharmacists". The specific number of participants is not provided in this summary.
• Data Provenance: The studies are conducted by West Pharma. Services IL, Ltd. (Israel-based manufacturer). These are prospective tests performed on the manufactured device, not retrospective data analysis. The data is generated from laboratory testing and simulated use, not from clinical patient data from specific countries.

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

• Not Applicable (N/A) for AI/ML device ground truth. This device is a mechanical fluid transfer device. Ground truth is established through adherence to recognized international standards and in-house validated test methods, rather than expert annotation of data.
• For the Human Factors Validation Study, the "experts" are the intended users of the device (nurses, physicians, and pharmacists). Their "qualification" is their professional role and ability to use the device safely and effectively in a simulated environment. The number of such participants is not specified.

4. Adjudication Method for the Test Set

• N/A for AI/ML device adjudication. There is no "adjudication" in the context of human expert review of AI outputs for this type of device. The verification processes involve engineering testing and quality control.

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. This is not an AI-powered diagnostic/assistance device, so no MRMC study or AI assistance evaluation was performed.

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

• N/A. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• N/A in the AI/ML sense. For this device, "ground truth" equates to:
  • Validated engineering specifications and performance benchmarks: Established by international standards (e.g., ISO, USP, EN ISO) and the manufacturer's own design control processes.
  • Biocompatibility standards: ISO 10993 series.
  • Sterility standards: ISO 11135.
  • Human Factors validation: Demonstrated safe and effective use by intended users in a simulated setting.

8. The Sample Size for the Training Set

• N/A. There is no "training set" as this is not an AI/ML device.

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

• N/A. There is no "training set" and thus no ground truth establishment for such a set.

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The Vial2Bag Advanced™ 20mm Admixture Device is indicated to serve as a connection between a 50, 100 or 250mL IV bag, vial with 20mm closure, and an external IV administration set. The integrated Vial Adapter makes it possible to reconstitute and/or admix drugs prior to administration to the patient.

The Vial2Bag Advanced [M 20mm Admixture Device is a single use, fluid transfer device that allows for the reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution, through the IV bag administration port. The device consists of the body, Protector, IV Port, and an integrated vial adapter. The device is provided as a sterile, non-pyrogenic product. The device is intended to be used with standard drug vials with a seal diameter of 20mm and an elastomeric stopper. The Vial2Bag Advanced1™ 20mm Admixture Device is designed to work with a standard 50, 100, or 250mL IV bag and an external IV administration set. The device is limited to a single device configuration. Users should not attach a Vial2Bag Advanced™ 20 mm Admixture Device to another Vial2Bag Advanced™ 20mm Admixture Device. The device does not contain any medicinal substances and there are no additional accessories needed or provided with the Vial2Bag Advanced™ 20mm Admixture Device for the device to meet its intended purpose.

The provided text is a 510(k) summary for a medical device (Vial2Bag Advanced™ 20mm Admixture Device) and does not describe a study involving an AI/Machine Learning diagnostic device. Therefore, I cannot extract information related to acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, or training set details as these concepts are not applicable to the information provided.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Indications for Use: The device is indicated to serve as a connection between an IV bag, vial, and an external IV administration set for reconstituting and/or admixing drugs.
• Performance Testing: Bench tests were conducted to ensure the device met design and performance requirements, conformity to standards (ISO 8536-42010/ Amd.1:2013), and internal specifications (e.g., tensile detachment force, leakage).
• Biocompatibility Testing: Tests were performed according to ISO 10993-1, including cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, material mediated pyrogenicity, systemic (subacute) toxicity, ASTM hemolysis, and particulate testing.
• Sterilization: The device relies on Ethylene Oxide sterilization, validated to ISO 11135:2014, achieving a sterility assurance level (SAL) of 10-6.
• No Clinical Data: The document explicitly states, "No clinical trial was performed for Vial2Bag Advanced™ 20mm Admixture Device."

The acceptance criteria for this type of device would primarily be related to its physical performance, safety (biocompatibility), and sterility, rather than diagnostic accuracy or human reader improvement, as it is a fluid transfer device, not an AI-powered diagnostic tool.

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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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The Vial2Bag is indicated to serve as a cornecting part between the IV bag and an external IV Line. The Vial2Bag has a built in connector which makes it possible to admix drugs into the infusion solution using a Swabable Valve.

The Vial2Bag is designed to serve as a connecting part between the IV bag and an external IV Line while allowing safe and easy transfer of drugs/diluents from and into an IV bag. The product allows quick transfer of the contents of a syringe or vial into an IV bag. The Vial2Bag is an assembly of three components a spike, a Swabable valve and a twist-off.

The provided text describes the "Vial2Bag" device and its 510(k) submission, confirming its substantial equivalence to predicate devices. However, the document does not contain a detailed study demonstrating quantitative acceptance criteria or specific performance metrics.

Here's an breakdown of the information that can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text.

The document states: "All finished products are tested and must meet all required release specifications prior to distribution. The array of testing required for release include but are not limited to; Physical testing and visual examination (in-process and finished product)." However, it does not specify what these "required release specifications" or "acceptance criteria" are, nor does it report any quantitative performance data (e.g., flow rate, leak rates, durability metrics, etc.) for the Vial2Bag or the predicate devices.

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

Not available in the provided text.

The document mentions "testing" but does not specify sample sizes for any tests, nor does it describe the origin of any data (e.g., country of origin, retrospective or prospective nature).

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

Not applicable.

This information is relevant for studies involving the interpretation of data where a medical expert's judgment forms the ground truth (e.g., image analysis, diagnosis). The Vial2Bag is a medical device for fluid transfer, and its evaluation would typically involve engineering and functional testing rather than expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable.

As expertise-based ground truth is not relevant for this device, adjudication methods are also not applicable.

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

No, a MRMC comparative effectiveness study was not done.

The document focuses on substantial equivalence based on indications for use, design, material, sterility, and packaging compared to predicate devices. It does not describe any study involving human readers or an AI component, nor does it discuss human performance improvement with or without AI assistance.

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

No, a standalone study was not done.

This device does not have an algorithm or AI component, so a standalone performance study in that context is not relevant.

7. Type of Ground Truth Used

Functional and Safety Testing.

While not explicitly called "ground truth" in the AI/data science sense, the "ground truth" for this device would be established through:

• Physical testing and visual examination: Ensuring the device meets its design specifications, is free from defects, and functions as intended (e.g., no leaks, proper connection, sterile).
• Material compatibility testing: Adherence to ISO 10993-1 and/or USP VI requirements.
• Sterility testing: Ensuring the product is sterile.

These are established standards and laboratory test results, not expert consensus, pathology, or outcomes data in the typical clinical study sense.

8. Sample Size for the Training Set

Not applicable.

A training set is relevant for machine learning algorithms. This device does not involve such algorithms.

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

Not applicable.

As there is no training set for an algorithm, this question is not relevant.

In summary, the provided submission focuses on establishing substantial equivalence to previously cleared predicate devices for regulatory approval, rather than demonstrating performance against specific quantitative acceptance criteria through a detailed clinical or performance study with reported metrics.

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