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The ProSeal™ Closed System drug Transfer Device (CSTD) mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.

This FDA Submission is to include an authorization to legally market the ProSeal" Vented Universal Vial Adaptor to the existing ProSeal™ CSTD devices system of eleven (11) devices that were cleared for sales in the US, the most recent being the ToxiSeal™ Vial Adaptor (K241823).

The ProSeal™ Vented Universal Vial Adaptor is a component of the ProSeal™ CSTD system intended for connection with the interface membranes between any standard vials and ProSeal™ CSTD component devices for close system fluid transfer. When connected to a standard vial and engaged with a ProSeal™ Injector (Syringe Adaptor), fluid can be transferred to and from the connecting component device in a closed system. The ProSeal™ Vented Universal Vial Adaptor and its corresponding interface membranes exhibit a dry connection with the communicating surfaces in a fluid transfer. The use of this component and its appropriate ProSeal™ CSTD component device reduces the risk of microbial ingress for up to 168 hours (or 7 days). when used as intended.

The closed transfer of liquid that takes place with the use of the ProSeal™ CSTD system as follows:

• A double membrane septum design utilizing self-sealing elastomeric membranes tightly fits . together when the system components engage. A cannula within the ProSeal™ Injector housing perforates the double membrane for the transfer of liquid. When the cannula is retracted, the membranes seal off the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols, and also minimizing the risk of microbial contamination.

The provided text is a 510(k) summary for the ProSeal™ Vented Universal Vial Adaptor. It outlines the device description, indications for use, comparison to a predicate device, and performance data supporting substantial equivalence. However, it does not describe acceptance criteria for an AI/ML-enabled medical device performance study, nor does it provide details on the specific study that would prove such a device meets acceptance criteria.

The document pertains to a physical medical device (a vial adaptor) and its mechanical, material, and sterility performance, not a software-based AI/ML device for which metrics like sensitivity, specificity, or AUC would be relevant. Therefore, most of the requested information (sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance, training set details) is not applicable to this 510(k) submission.

The closest analogous information in this document relates to functional performance testing and biocompatibility testing for the physical device.

Here's how to interpret the available information in the context of the prompt, acknowledging the mismatch:

The document effectively describes the "acceptance criteria" and "study" for a physical medical device based on regulatory standards and comparison to a predicate, not an AI/ML device.

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

The document doesn't present a table of quantitative acceptance criteria in the typical AI/ML sense (e.g., target AUC, sensitivity). Instead, it states that the device was tested and demonstrated to be in conformance with recognized ISO and FDA standards, and that "Performance testing demonstrates that this difference [in air-vent size] does not raise new questions regarding safety and effectiveness." The acceptance criteria for this physical device are the successful completion and conformance to these standards and the demonstration of substantial equivalence to the predicate.

Here's a reinterpretation of their "acceptance criteria" based on the provided text, focusing on the functional performance tests listed:

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The ProSeal™ Closed System drug Transfer Device (CSTD) mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.

The ProSeal™ CSTD is a sterile, single-use, pyrogen-free CSTD for the preparation, reconstitution, compounding, and administration of antineoplastic and hazardous drugs, intended for use in clinical settings by trained health care professionals and/or pharmacists.

The ProSeal™ Closed System Bag Access is a component of the ProSeal™ CSTD system which is intended for connection to a standard I.V. bag and appropriate ProSeal™ CSTD component devices for the injection and infusion of I.V. infusion fluids. It is an adaptor between IV bags and ProSeal™ CSTD components for closed system fluid transfer into and out of the I.V. bag. The Subject bag access is compatible with the ProSeal™ Injector or the ProSeal™ Injector Plus (cleared K240171) and other ProSeal™ component devices, e.g. ProSeal™ Closed System Administration Set (for infusion from the I.V. bag). The ProSeal™ Closed System Bag Access and all its corresponding interface membranes exhibit a dry connection with the communicating surfaces in a fluid transfer. The use of this component device and its appropriate ProSeal CSTD connecting component device reduces the risk of microbial ingress for up to 168 hours or 7 days, when used as intended.

The closed transfer of liquid that takes place with the use of the ProSeal™ CSTD system as follows:

• A double membrane septum design utilizing self-sealing elastomeric membranes tightly fits . together when the system components engage. A cannula within the ProSeal™ Injector Plus housing perforates the double membranes for the transfer of liquid. When the cannula is retracted, the membranes seal off the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols, and spills, and also minimizing the risk of microbial contamination, when used as intended.

Based on the provided FDA 510(k) summary for the ProSeal™ Closed System Bag Access (K241988), here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Disclaimer: This document is a 510(k) summary, which provides an overview of the substantial equivalence determination. It does not contain the full details of all the studies performed. Therefore, specific quantitative performance metrics beyond what is explicitly stated for acceptance and observed results are not available in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes functional performance, biocompatibility, sterility, shipping, and shelf-life testing. While specific quantitative acceptance criteria are not explicitly listed in a single table with corresponding numerical results, the document states conformance to various ISO and FDA recognized standards. The "Comment/Discussion" column in the comparison table indicates "Same" or "Similar" for many characteristics, implying that the acceptance criteria are met by demonstrating equivalence to the predicate device and adherence to standards.

For functional performance, the document lists the following tests and their corresponding standards, implying that meeting these standards constitutes the acceptance criteria. The performance data "supporting substantial equivalence" suggests that the device met these criteria.

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

The document does not explicitly state the specific sample sizes used for each of the functional performance, biocompatibility, or sterility tests. It refers to various ISO and ASTM standards, which typically prescribe minimum sample sizes for such tests.

• Data Provenance: The document states "Bench performance verifications and validations referred-to and performed" and "testing data on devices cleared under K222929." This indicates that the testing was primarily benchtop testing (laboratory-based) and retrospective, leveraging data from previously cleared devices within the ProSeal™ CSTD system (specifically K222929). There is no mention of data provenance by country of origin or specific patient data since the studies are physical/chemical rather than clinical.

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

This section is Not Applicable to this 510(k) submission. The device is a physical medical device (intravascular administration set component), not an AI/ML diagnostic or image analysis device that requires expert human interpretation to establish ground truth from medical images or clinical data. Its performance is evaluated through physical, mechanical, and biological testing against established standards.

4. Adjudication Method for the Test Set

This section is Not Applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies involving human interpretation or subjective assessments, especially for AI/ML devices where ground truth might be derived from multiple expert opinions. For a physical device undergoing performance and safety testing against objective engineering and biological standards, such adjudication is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of how much Human Readers Improve with AI vs. without AI Assistance

This section is Not Applicable. An MRMC study is relevant for diagnostic or AI-assisted diagnostic devices that evaluate human reader performance. The ProSeal™ Closed System Bag Access is a hardware component for drug transfer and does not involve human readers interpreting medical cases.

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

This section is Not Applicable. This concept applies to AI/ML software. The ProSeal™ Closed System Bag Access is a physical device component.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by conformance to internationally recognized performance standards (e.g., ISO, ASTM, USP, ANSI/AAMI) for medical devices, specifically for intravascular administration sets and closed system transfer devices. This includes:

• Engineering/Physical Standards: Defining acceptable ranges for leak integrity, tensile strength, penetration force, package integrity, etc.
• Biological Standards: Defining acceptable levels for biocompatibility (cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity) and sterility.
• Functional Claim Validation: Demonstration of preventing microbial ingress and vapor containment as defined by specific test protocols (e.g., microbial ingress test, vapor containment test).

8. The Sample Size for the Training Set

This section is Not Applicable. The product is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the machine learning sense. The design and manufacturing processes are validated through engineering principles and compliance with quality systems (e.g., 21 CFR Part 820).

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

This section is Not Applicable for the same reason as point 8.

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The ProSeal™ Closed System drug Transfer Device (CSTD) mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days, when used as intended.

The ProSeal™ CSTD devices are single-use, sterile, non-pyrogenic CSTD component devices that are fitted to each other. They are used as sterile interfaces for the closed injections and withdrawals of liquids into and from the ProSeal™ CSTD component devices and external transfer devices. The ProSeal™ In Line Pump Set is a closed system in-line IV infusate/drug transfer adapter/ connector for providing closed system protection during hazardous drug administration when connected to a standard IV set at its distal end, with the proximal end attached to a mating ProSeal™ Injection Site (K240433) of a ProSeal™ CSTD component device such as the eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (K241442).

This document does not contain the information required to populate a table of acceptance criteria and reported device performance for a medical device that would involve AI or machine learning. The provided text is a 510(k) summary for a physical medical device (ProSeal™ In Line Pump Set), which is an intravascular administration set, and does not mention any AI components, software, or algorithms.

Therefore, questions related to:

1. Acceptance criteria and reported device performance (with AI metrics)
2. Sample size for the test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study and effect size
6. Standalone (algorithm only) performance
7. Type of ground truth used (for AI)
8. Sample size for the training set
9. How ground truth was established for the training set

cannot be answered from the provided text.

The document focuses on the substantial equivalence of the ProSeal™ In Line Pump Set to a predicate device (ProSeal™ Injector Plus) based on:

• Intended use and indications for use
• Technological characteristics (materials, design, sterilization, shelf-life)
• Performance data from bench testing demonstrating compliance with ISO standards for mechanical, fluidic, and safety aspects.
• Biocompatibility testing (per ISO 10993)
• Sterility, shipping, and shelf-life testing.

The performance data listed pertains to physical device attributes such as leak integrity, flow rate, Luer lock connection tests, sharps injury protection, needle bonding strength, resistance to temperature/pressure/dropping, water vapor impermeability, spiking port ability and adhesion, particulate non-contamination, and impermeability to microorganisms. These are standard engineering and biomedical tests for physical medical devices, not performance metrics for AI algorithms.

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