Search Results

The Mix2Vial® Transfer Device is intended for transferring drugs contained in two vials.

The subject device, Mix2Vial® Transfer Device (M2V), is a single-use, gamma sterilized, nonpyrogenic device intended for the transfer of drugs contained in two vials. The M2V consists of two vial adapter bodies with piercing spike and wings, connected back-to-back via a Luer connection, with an in-line filter.

The female vial adapter (clear) connects to the drug vial and the male vial adapter (blue) connects to the diluent vial. The vacuum present in the lyophilized drug vial draws in the contents of the diluent vial.

The female Luer connection interfaces to a syringe and has an in-line 5um filter that strains the drug or solution when aspirated out of the vial. The male connection has a "Tight Grip" that provides a secure connection to the diluent vial having a 20mm neck diameter.

Puncturing the elastomeric closure or "stopper" of a drug or diluent vial is achieved by means of an integral polycarbonate cannulated spike located in the center of each Vial Adapter (VA) body of the M2V. Each side of the device (diluent vial side and drug vial side) is a polycarbonate molded part containing a Luer port.

After reconstitution, the drug can be administered by disconnecting the diluent vial and connecting a needleless syringe to the female Luer Lock of the female Vial Adapter. The device does not contain any medicinal substances and can be used with drug vials/diluent vials with a neck diameter of 20mm.

I am sorry, but the provided text describes a 510(k) premarket notification for a medical device (Mix2Vial® Transfer Device) and does not contain any information about a study involving an AI/Machine Learning device or its acceptance criteria within the context of AI performance metrics like sensitivity, specificity, or AUC.

The document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for non-AI medical devices. The performance data discussed relates to physical and chemical properties of the device (e.g., fragmentation, particulate, Luer stability, sterility, biocompatibility, force measurements), not the performance of an AI algorithm.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to AI.
2. Sample sizes used for a test set (in the context of AI).
3. Data provenance for an AI test set.
4. Number of experts establishing ground truth for AI.
5. Adjudication method for an AI test set.
6. MRMC comparative effectiveness study results.
7. Standalone AI performance.
8. Type of ground truth (for AI).
9. Training set sample size (for AI).
10. Ground truth establishment for a training set (for AI).

The document explicitly states: "Clinical trials were not performed for the Mix2Vial® Transfer Device." This further confirms that there are no clinical performance studies, let alone AI performance studies, described in this regulatory submission.

Ask a specific question about this device

The Vial Adapter is indicated for the transfer of drugs contained in a vial.

The Vial Adapter (VA) 20mm is a single-use device that allows for the transfer of drugs contained in a vial. The device is a one-piece polycarbonate molded part with a standard female Luer port for the connection of a syringe. Puncturing the elastomeric closure of a drug vial is achieved by means of an integral plastic cannulated spike located in the center of the Vial Adapter component. The VA 20mm device is supplied with or without an inline filter, based on catalog number. The VA is sterilized utilizing gamma irradiation and is packaged in a Polyethylene Terephthalate Glycol (PETG) blister enclosure. The VA 20mm is packaged in either a Vial First (VF) or a Syringe First (SF) orientation. The device does not contain any medicinal substances or moving parts and is intended for use with standard drug vials having a neck diameter of 20mm.

The provided text describes a 510(k) premarket notification for a medical device called "Vial Adapter 20mm". This is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study designed to prove the device meets acceptance criteria in the typical academic or clinical trial sense.

Therefore, many of the requested categories (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable in this context, as they pertain to clinical or AI/algorithm performance studies. This document focuses on bench testing and regulatory comparisons.

Here's a breakdown of the information that can be extracted:

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

The document lists various performance tests conducted. For each test, the acceptance criteria are implicitly defined by the referenced standard or the success of the "in-house test method." The reported device performance is indicated by statements like "meets all applicable design and performance requirements," "conforms to applicable external and internal standards," and "successfully conducted." Specific numerical performance data or detailed results are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the provided text.
• Data Provenance: The tests are "non-clinical performance data" and "bench performance tests." The manufacturing facility is in Ra'anana, Israel. The data would be prospective for the purpose of this submission (i.e., new testing done for this device).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This is not a study relying on expert interpretation for ground truth. It's an engineering and regulatory compliance submission based on physical and chemical testing.

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

• Not Applicable. No human adjudication of results is described for these bench tests; results are objective measurements against standards.

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 passive, non-electrical, non-software-enabled mechanical component (Vial Adapter), not an AI or imaging device that would involve human readers or AI assistance.

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

• Not Applicable. As mentioned above, this is a mechanical medical device, not an algorithm.

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

• The "ground truth" for the performance tests outlined is defined by the specified international and in-house standards (e.g., ISO, USP, ASTM) that the device must comply with. For biocompatibility and sterilization, it's compliance with safety thresholds and validation standards.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning study, so there is no training set.

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

• Not Applicable. As there is no training set, this question is irrelevant.

Ask a specific question about this device

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.

Ask a specific question about this device

The device is intended for the transfer and injection of drugs contained in a vial.

The subject device, MixJect® Transfer Device (MXJ), is a single-use, gamma sterilized, nonpyrogenic device intended for the transfer and injection of drugs contained in a vial. The MXJ device is intended for use by Healthcare Professionals (HCPs) in a clinical, hospital, or other healthcare environment. The subject device is available by prescription use only and has no known contraindications. The MXJ device does not contain any medicinal substances and is only intended for use with drug vials having a neck diameter of 13mm. The subject device has a 3-year shelf life. The MXJ device configuration consists of four main components inclusive of a 30-gauge needle, a vial adapter including integral cannulated spike, MXJ Body, and MXJ Core. The subject device interfaces with a syringe (not supplied) that connects to the female Luer lock port located in the main body of the MXJ device. The MXJ Vial Adapter component connects to a drug vial having a neck diameter of 13mm. The Vial Adapter component contains a piercing spike and a female Luer lock connector. Puncturing of the drug vial stopper membrane is achieved by means of an integral spike located in the center of the MXJ Vial Adapter component. Once the drug vial stopper membrane is breached by the cannulated spike, fluid can travel from the drug vial into the MXJ device main body. A prefilled diluent syringe (not supplied) is then connected to MXJ female Luer lock port. The diluent is injected from the syringe into the drug vial. The reconstituted medicament is then aspirated back into the syringe. The MXJ device is then twisted in a counterclockwise direction, changing the fluid path from the syringe-vial to the syringe-needle. After reconstitution and aspiration, the drug is ready to be administered through the attached MXJ needle. The MXJ primary device package consists of a polyethylene terephthalate glycol (PETG) blister sealed with a Tyvek® lid sealed on top of the blister pack.

The provided FDA 510(k) summary for the MixJect® Transfer Device (K230464) describes performance testing, but it does not specify explicit acceptance criteria in a quantitative manner or provide specific performance data points in a table as requested. Instead, it states that testing "confirm[s] the MixJect® Transfer Device meets all applicable design and performance requirements throughout its defined shelf life and verify conformity to the applicable external and internal standards and demonstrate substantial equivalence to the predicate device."

Therefore, I cannot generate a table of acceptance criteria and reported device performance with specific numerical values based on this document. However, I can infer the types of performance metrics and the general conclusion of the study.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, specific quantitative acceptance criteria and reported performance values are not provided in this document. The document primarily lists the types of performance tests conducted and generally states that the device meets requirements and standards.

Inferred Performance Metrics (from "Performance Testing" section):

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets its requirements is a series of non-clinical bench performance tests and biocompatibility tests as detailed in the "Performance Data" section of the 510(k) submission.

2. Sample Size and Data Provenance:

• Sample Size for Test Set: The document does not specify the sample size (number of devices) used for each individual performance test or biocompatibility test.
• Data Provenance: The document does not explicitly state the country of origin of the data for the performance or biocompatibility tests. It indicates the manufacturer, West Pharma. Services IL, Ltd., is located in Ra'anana, Israel. The studies are retrospective in the sense that they are laboratory and bench studies conducted on the device, not ongoing clinical observations.

3. Number of Experts and Qualifications:

• Not Applicable. For non-clinical bench testing and biocompatibility assessments, the ground truth is established by objective measurements against recognized international and internal standards, rather than expert consensus on medical images or diagnoses. These tests are typically performed by qualified laboratory technicians and overseen by engineers or scientists with expertise in material science, mechanical testing, and biocompatibility, who interpret the results against established regulatory requirements and standards.

4. Adjudication Method:

• Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is required for ground truth labeling, often for diagnostic accuracy studies. This document reports on bench and biocompatibility testing.

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

• No. The document explicitly states: "Clinical trials were not performed for the MixJect® Transfer Device." Therefore, no MRMC comparative effectiveness study was conducted, and no effect size for human reader improvement with AI assistance is applicable or reported.

6. Standalone Performance Study:

• Yes, in the context of a medical device. The entire "Performance Data" section describes standalone performance of the device itself through a variety of engineering, material, and biological safety tests (bench tests, biocompatibility tests). These tests establish the device's inherent properties and functionality without a human-in-the-loop performance assessment (which would be a clinical trial).

7. Type of Ground Truth Used:

• The ground truth for the performance tests and biocompatibility tests is based on:
  • International Standards: e.g., ISO 8536-2, USP , ISO 80369-7, ISO 10993 series, BS EN ISO 11137 series.
  • In-house test methods: Developed and validated by the manufacturer to assess specific device functions.
  • Established biological principles and safety thresholds: For biocompatibility and sterility.

8. Sample Size for Training Set:

• Not Applicable. This device is a physical medical device (an intravascular administration set), not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device design and manufacturing processes are likely informed by engineering principles, material science knowledge, and previous device iterations.

9. How Ground Truth for Training Set Was Established:

• Not Applicable. As there is no AI/ML algorithm or training set, this question is not relevant.

Ask a specific question about this device

Transfer of drugs contained in a vial.

The Vented Vial Adapter HU, is a single use, sterile, non-pyrogenic medical device intended for the transfer of drugs contained in a vial. The device is intended for use in the preparation of drugs for home use, in hospitals, or outpatient nursing units as used/administered by the patient, caregiver, or Healthcare Professionals (HPCs). The subject device is by prescription use only and does not have contraindications. The device does not contain any medicinal substances and there are no additional accessories provided for use with the product. The device has a 3-year shelf life.

The Vented Vial Adapter HU allows for the connection of a standard accessory with a female Luer lock to be connected to a vial. The vial adapter body with tight grip hold ("wings") is intended to be attached to a standard drug vial with a neck diameter of 20mm. The device contains a piercing spike, cap with air filter, vent and a female Luer lock connector for attachment to a standard accessory. This dual lumen spike design facilitates rapid withdrawal of the drug/solution without pressurizing the vial by allowing inbound air aspiration through the air filter.

The materials of construction of the VVA HU body and cap are polycarbonate, with a 0.2um hydrophobic air filter comprised of 100% expanded PTFE membrane over non-woven polyester membrane support.

The provided document is a 510(k) premarket notification for a medical device called the "Vented Vial Adapter 20mm". This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than requiring a full clinical trial for safety and efficacy. Therefore, the information typically found in a study proving acceptance criteria for AI/ML devices, such as sample sizes for test sets, expert consensus, and comparative effectiveness studies, is not present here.

Instead, the document focuses on non-clinical performance data and biocompatibility testing to demonstrate that the new device meets relevant standards and is substantially equivalent to a previously cleared predicate device.

Here's an analysis of the provided information within the context of your request:

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

The document does not explicitly provide a table of acceptance criteria alongside reported device performance in the typical sense of a clinical study measuring a specific outcome (e.g., sensitivity, specificity for an AI diagnostic). Instead, it lists various performance tests conducted and indicates that the device "met the applicable design and performance requirements" and that "all product design requirements are verified."

Below is a table summarizing the types of tests conducted, which implicitly serve as criteria for performance, and the general statement of their success:

Regarding the other requested information:

• 2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

  • The document does not specify sample sizes for each non-clinical performance test. It mentions that an "in-house test method" was often used.
  • The data provenance is not explicitly stated in terms of country of origin for the non-clinical tests. The manufacturer is West Pharma. Services IL, Ltd. in Ra'anana, Israel. The tests are non-clinical bench tests, not involving human data.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

  • This question is not applicable to a device submission of this nature. The "ground truth" for these tests are objective measurements against defined standards or specified functional parameters, not subjective expert interpretations.

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

  • This is not applicable. The performance testing is based on objective measurements against engineering and biological standards, not on human adjudication of subjective findings.

• 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:

  • No MRMC or comparative effectiveness study was done. This device is a passive medical device (a vial adapter), not an AI/ML diagnostic or assistive technology.

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

  • Not applicable, as this is not an AI/ML algorithm or software device.

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

  • For performance testing, the "ground truth" refers to the established specifications, international standards (e.g., ISO, BS EN ISO), or in-house defined criteria for mechanical properties, fluid dynamics, and biological safety. For biocompatibility and sterilization, the ground truth is defined by specific ISO standards and their associated pass/fail criteria (e.g., for cytotoxicity, sensitization, sterility assurance level).

• 8. The sample size for the training set:

  • Not applicable, as this is not an AI/ML device that requires training data.

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

  • Not applicable, as this is not an AI/ML device that requires a training set or associated ground truth.

Ask a specific question about this device