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Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a bag to an IV fluid administration device.

The Medline Bag Decanter is a non-pyrogenic, single use, disposable device, which is supplied sterile. The device comprises of a one-piece transfer device with protective flexible caps at either end. The device is an injection molded hollow tube with a spiked end used to access the source container and withdraw fluid. The spike component is designed with a built-in splash guard. The device is designed for use in transferring IV fluids/medication from a bag to an IV fluid administration device.

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To allow multiple needleless accesses to an injection medication vial for the purpose of facilitating the withdrawal or addition of drugs/solutions from or to the vial.

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Microtek decanters are intended for the aseptic transfer of solutions (eg. IV fluids and medications) from IV containers

• Bag decanters are for use in transferring IV fluids and medication from a bag to an IV fluid administration device.
• Vial decanters are for use in transferring IV fluids and medications from a vial to an IV fluid administration device.
• Transfer devices are for use in transferring IV fluids and medications from a vial or medication container to an IV fluid administration device.

Microtek decanters are suitable for adult and pediatric patients. The use of decanters is at the discretion of the healthcare professional.

Microtek decanters and transfer devices are provided sterile and for use in a single procedure only. They consist of a hollow tube with protective removable caps at either end. The injection molded hollow tube has at least one spiked end used to access the source container to initiate fluid transfer. The vial decanter includes a built-in splash guard.

Decanters and transfer devices are designed to transfer medical fluids (e.g.: medications and solutions) between various containers.

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HYHUB™ and HYHUB™ Duo vial access devices are indicated for patients 17 years of age or older to allow a drug to be transferred from vials without using a needle, as prescribed, in a home environment or clinical setting.

The HYHUB™ and HYHUB™ DUO vial access devices (VAD) are a stand-alone, single-use, disposable, non-pyrogenic, gamma sterilized device, which are intended to support the infusion of two medicinal liquids, as prescribed, in a home environment or clinical setting. The VAD is designed to accommodate up to two (2) or four (4) dual vial units (DVU) to be docked onto the VAD infusion tray which allows the transfer of medicinal liquids in a sequential, needleless manner using standard connections for syringes, applicable pumps, and infusion sets.

The FDA 510(k) clearance letter for the HyHub™ and HyHub™ Duo Vial Access Devices (K243404) does not contain the level of detail typically found in a clinical study report or a summary of clinical performance for AI/ML-based devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device through bench testing, biocompatibility testing, and a comparison of technological characteristics.

Therefore, many of the requested categories relating to acceptance criteria for AI inference, dedicated test sets, expert adjudication, MRMC studies, standalone algorithm performance, and detailed training data are not applicable or cannot be extracted from this document. The document describes a medical device, not an AI/ML algorithm.

However, I can extract the information relevant to the performance testing that was conducted to demonstrate this device meets its requirements for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For a traditional medical device like the HyHub, "acceptance criteria" are generally tied to meeting specific performance standards based on recognized test methods or internal protocols. The document does not explicitly state numerical acceptance criteria for each test alongside performance data in a single table, but it lists the tests performed and implies successful completion for substantial equivalence.

Since the document does not provide specific numerical acceptance criteria and reported performance results for each test (e.g., maximum allowable leak rate vs. measured leak rate), I can only present the categories of tests performed.

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

This information is not provided in the FDA 510(k) letter. The document mentions "bench tests" and "biocompatibility evaluation," implying a set of physical devices were tested rather than a "test set" of data in the AI/ML context. No details on the number of units tested per bench test are given, nor is information on geographical origin or retrospective/prospective nature of data for this type of hardware device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable for this type of device and submission. The "ground truth" for a vial access device is its physical performance against established engineering and biocompatibility standards, not expert interpretation of medical images or data.

4. Adjudication Method

Not applicable for this device type. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or labeling of data, typically for AI/ML device validation.

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

No. An MRMC study is not mentioned because this device is a physical vial access device, not an AI/ML diagnostic or assistive tool for human readers.

6. Standalone Performance Study (Algorithm Only)

No. This is a physical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on established engineering and biocompatibility standards, and physical performance measurements.

• Bench Testing: Objective measurements against documented specifications for leak rates, particulate generation, flow rates, residual volumes, connector compatibility, and package integrity.
• Biocompatibility Testing: Results from established in-vitro and in-vivo tests (e.g., cytotoxicity, sensitization, systemic toxicity, hemolysis) against defined biological safety endpoints as per ISO 10993-1.
• Sterility Validation: Demonstration of a Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11137 (for gamma radiation) or ISO 11135 (for ethylene oxide).
• Pyrogenicity: Testing to confirm the device is non-pyrogenic.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.

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

Not applicable, as there is no "training set" for this device.

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The Arisure® Closed Male Luer with Spike Adapter serves as a connector between an IV container and a standard IV set.

The Arisure Closed Male Luer with Spike Adapter, also referred to as Arisure CML with Spike Adapter or CML with Spike Adapter, is an extension of the predicate device, i.e., Closed Male Luer. The primary components of the CML with Spike Adapter include: a Closed Male Luer, a Male Luer Lock Connector, and an Extended Spike Adapter.

The subject device allows for administration set preservation when administering multiple drug therapies to the same patient. It provides a needle-free, drip-free connection between an IV bag or a rigid container and an IV administration set. The CML side provides a luer lock connection to a Bag Spike with Neutral Valve. It also gives the user a drip-free disconnect when needing to use multiple bags or bottles for the infusion. The Spike Adapter side allows for a secure connection to any ISO standard IV spike. An IV administration set can be connected safely and securely to the device through a pierceable septum.

The CML with Spike Adapter is designed to comply with ISO 8536-4:2019 as appropriate.

The Arisure® Closed Male Luer with Spike Adapter (YM060) is an extravascular administration set.
The device's performance was evaluated through a series of non-clinical tests.

Acceptance Criteria and Device Performance:

Study Details:

1. Sample Size and Data Provenance for Test Set:

   • The document does not explicitly state the specific sample sizes used for each individual performance test (e.g., leakage, flow rate). It generally indicates that "Aged, packaged parts underwent the appropriate testing" for shelf-life, and "The following tests were completed with passing results."
   • The data provenance is not specified (e.g., country of origin). The studies appear to be non-clinical performance and laboratory tests conducted by the manufacturer, Yukon Medical, LLC. These are retrospective data in the sense that they were collected and analyzed to support the 510(k) submission.

2. Number of Experts and Qualifications for Ground Truth:

   • This information is not applicable. The device is a medical accessory, and its performance criteria are objective, based on engineering, material, and biological standards (e.g., ISO, ASTM). The "ground truth" for these tests is established by the specifications of these standards, not expert consensus in diagnostic interpretation.

3. Adjudication Method for Test Set:

   • This information is not applicable as the evaluation involves objective performance metrics against established standards, not interpretation by human experts.

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

   • No MRMC comparative effectiveness study was done. This type of study is typically performed for diagnostic or imaging devices where human interpretation is involved. The Arisure® Closed Male Luer with Spike Adapter is a medical accessory with objective performance characteristics.

5. Standalone Performance Study:

   • Yes, a standalone performance study was done in the sense that the device's performance was evaluated independently against engineering, material, and biological standards. This involved testing various mechanical, chemical, and biological attributes of the device without human-in-the-loop performance measurement related to its primary function as a connector.

6. Type of Ground Truth Used:

   • The ground truth used for performance evaluation was based on established international and national standards for medical devices, infusion equipment, and material biocompatibility. These include, but are not limited to, ISO 8536-4, ISO 80369-7, IEC 62366-1, ISO 22413, ISO 15747, ISO 10993 series, ASTM standards (e.g., D4169, F1980), and EN/SS-EN standards for sterilization. The "ground truth" is defined by the measurable parameters and acceptance limits specified within these standards.

7. Sample Size for Training Set:

   • The document describes performance testing for a medical device accessory and does not involve AI or machine learning algorithms that would typically require a "training set." Therefore, this information is not applicable.

8. How Ground Truth for Training Set Was Established:

   • As there is no AI/machine learning component described for this device, a training set and its associated ground truth establishment are not relevant to this submission.

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Rio™ Drug Reconstitution Transfer Device is indicated for single-use reconstituting or mixing of liquid or lyophilized drug in a vial, and the aseptic transfer of the reconstituted drug into the multi-port LifeCare IV container system (IV bag) for patient infusion administration.

The Rio™ Drug Reconstitution Transfer Device (Rio) is a single use, sterile, two-way, drug transfer device that is designed to connect an ICU Medical LifeCare IV container system (IV bag)(up to 500 mL) via the drug additive port, to a drug vial having either a 13mm or 20mm stopper closure for reconstituting or mixing and aseptic transfer of the drug from the vial into the solution of the IV bag. Once connected, Rio is not separated from the IV bag or vial and should be disposed of with the IV bag when administration is complete. Rio is intended to be used in a pharmacy setting or patient care area, by trained clinicians.
The Rio design consists of a needle-free port spike that connects to the compatible IV bag on one end, and a vial spike on the other end to connect a standard liquid or lyophilized/powdered drug vial. The bag spike and vial spike contain protective caps that maintain the sterility of the device until the caps are removed prior to use. Rio also includes a flow director (rotating handle) that will isolate the fluid between the vial and bag until manipulated by the pharmacist or clinician to allow two-way fluid transfer between the vial and bag.

The provided text is a 510(k) summary for the Rio™ Drug Reconstitution Transfer Device. This document focuses on demonstrating substantial equivalence to a predicate device (K192154), rather than providing detailed acceptance criteria and study results for de novo device performance validation.

Therefore, the document does not contain the specific information required to answer most of your questions about:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their provenance.
• Number of experts, their qualifications, or adjudication methods for ground truth.
• MRMC or standalone comparative effectiveness studies.
• Types of ground truth used.
• Sample size or methods for establishing ground truth for training sets.

The document indicates that clinical data was not needed to support the substantial equivalence determination, which means there are no clinical studies of the type you're asking about (e.g., MRMC studies).

However, I can extract the information that is present regarding non-clinical testing and how it supports the device's conformance:

Summary of Non-Clinical Testing and Conformance:

The manufacturer states that "Non-clinical verification has been conducted to evaluate the safety, performance and functionality. The results of these test have demonstrated the overall safety of the subject device and ultimately supports a substantial equivalence device."

The document generally states that "Test results from the performance testing conducted demonstrate the subject device met all acceptance criteria requirements." However, it does not explicitly list the quantitative acceptance criteria or the specific numerical results obtained for each test.

Here's what can be gleaned about the non-clinical testing performed:

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

• Acceptance Criteria: While specific numerical criteria are not provided, the testing aimed to meet various ISO and USP standards. For example, for particulates, the device had to "meet USP <788> requirements." For sterility, it had to meet a "SAL 1x 10-6."
• Reported Device Performance: The summary states that the device "met all acceptance criteria requirements" for the listed tests. No specific numerical performance values are given.

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

• Not specified in the provided text.

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

• Not applicable/Not specified. This is not a study involving expert readers or ground truth establishment in the context of diagnostic AI.

4. Adjudication method for the test set:

• Not applicable/Not specified.

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. The document explicitly states: "Clinical data was not needed to support a substantial equivalence determination." This is not an AI device or a diagnostic device.

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

• No. This is a physical, mechanical device, not an algorithm.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" is established by adherence to recognized standards (ISO, USP) and engineering specifications for mechanical and material performance. For example, for particulate testing, the USP <788> limits define the "ground truth" for acceptable particulate levels. For sterility, the SAL 1x10^-6 is the "ground truth" for validated sterility.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable.

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The 20mm SmartSite ™ Vented Vial Access Device is intended for use by healthcare professionals, patients, and/or caregivers in a wide variety of healthcare and home use environments for reconstitution or dispensing of medication. The SmartSite Vented Vial Access Device is indicated for use with standard 20 mm rubber-stopper medication vials for reconstitution or dispensing of medications.

The 20mm SmartSite™ Vented Vial Access Device is a stand-alone, sterile, single-use, disposable device which permits access to a medication vial without the use of a needle. It consists of a vial spike, the vial retention shroud, a hydrophobic filter assembly and a SmartSite™ needle-free valve.

The SmartSite™ Vented Vial Access Device is microbiologically closed. When used in a USP<797> compliant pharmaceutical compounding and storage environment, the SmartSite™ Vented Vial Access Device is capable of maintaining the sterility of vial medications for up to 7 days.

The provided text is a 510(k) summary for the "SmartSite™ Vented Vial Access Device" and does not contain any information about a study proving the device meets specific acceptance criteria using a test set of medical images or other data that would involve ground truth established by experts.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (SmartSite® Vented Vial Access Device, K151963) through comparisons of intended use, design, technology, materials, and performance characteristics.

The "testing" mentioned in the document refers to engineering and biocompatibility tests for the physical device, not an AI/algorithm-based performance study. For example:

• Human Factors Engineering/Usability Engineering Study: This relates to how users interact with the physical device, not an algorithm's performance on data.
• Particulate Contamination Testing, Fragmentation Testing, Attachment force, Flow rate, Shelf life, etc.: These are physical performance tests of the device itself.
• Chemical Characterization Testing: Relates to the material properties of the device.
• Biocompatibility Testing: Relates to the device's interaction with the body (e.g., cytotoxicity, irritation).

Therefore, I cannot provide the requested information regarding acceptance criteria and study details as they pertain to an AI/algorithm-based device and its performance metrics against a ground truth. The document does not describe such a study.

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The nextaro® va. 15mm, 5um is indicated for the transfer and mixing of drugs contained in vials.

The nextaro® va, 15mm, 5μm is a sterile packaged vial adapter for single withdrawal of drug solutions with a single-use syringe via Luer adapter from drug vials or for one-time injection of a low-particle and sterile solution with immediate withdrawal of the prepared drug solution with a single-use syringe via Luer adapter from drug vials.

The provided text describes a 510(k) premarket notification for a medical device called nextaro® va, 15mm, 5µm. This document is a regulatory submission to the FDA, asserting that the new device is substantially equivalent to a legally marketed predicate device (nextaro® va, K183187).

This type of submission focuses on demonstrating substantial equivalence rather than proving device performance against specific clinical acceptance criteria in the way an AI-powered diagnostic device would. Therefore, the information typically requested in your prompt regarding AI/machine learning device studies (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, etc.) is not applicable to this document. This document describes a physical medical device (an intravascular administration set) and changes to its physical characteristics, not an AI or software device.

However, I can extract the information that is relevant to the "acceptance criteria" and "proof" provided within this regulatory context.

Acceptance Criteria and Study for nextaro® va, 15mm, 5µm

The "acceptance criteria" in this context refer to the performance standards and regulatory requirements that the modified device must meet to demonstrate its substantial equivalence to the predicate device and ensure its safety and effectiveness for its intended use. The "study that proves" the device meets these criteria is the performance testing conducted.

1. Table of Acceptance Criteria and Reported Device Performance

Instead of a typical AI performance table (e.g., sensitivity, specificity), the "acceptance criteria" here are defined by various testing standards and the "reported device performance" is a general statement of compliance with those standards.

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

• Sample Size: The document does not specify the exact sample sizes (N) for each of the performance tests. Regulatory submissions often report that tests were conducted according to the relevant standards, which themselves may define minimum sample sizes for specific tests.
• Data Provenance: The tests were conducted by the manufacturer, SFM Medical Devices GmbH, located in Waechtersbach, Hessen, Germany. The data is prospective, as it was generated specifically for this 510(k) submission to demonstrate the performance of the new device.

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

• This is not applicable. For a physical medical device like an intravascular administration set, "ground truth" is established by adherence to recognized international and national standards (e.g., ISO, ASTM, DIN, USP) and by direct physical and chemical testing, not by expert human interpretation of data in the way a diagnostic AI device would require (e.g., radiologists reviewing images). The acceptance criteria are objective measurements against these standards.

4. Adjudication Method for the Test Set:

• This is not applicable as the tests are objective physical and chemical analyses based on established standards, not subjective interpretations requiring adjudication.

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

• This is not applicable. MRMC studies are relevant for diagnostic devices where human readers interpret data, often with or without AI assistance, to assess diagnostic performance. This device is an intravenous fluid transfer set, not a diagnostic tool requiring human interpretation.

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

• This is not applicable. This is not an AI/software algorithm. Its "performance" is determined by its physical and chemical properties and functionality, not by an algorithm's output.

7. The Type of Ground Truth Used:

• For this device, the "ground truth" is established through objective measurements and analyses against pre-defined engineering, chemical, and biological performance specifications derived from international and national standards (e.g., ISO 10993 for biocompatibility, ISO 8536-4 for infusions sets, ISO 22413 for vial adapters, ISO 80369-7 for Luer connectors, ISO 11607 for packaging). These standards represent the accepted scientific and engineering consensus for safe and effective device performance.

8. The Sample Size for the Training Set:

• This is not applicable. This is a physical device, not an AI/machine learning model that undergoes "training" on a dataset. The device design and manufacturing processes are developed through engineering and quality management systems, not through machine learning.

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

• This is not applicable for the reasons stated above.

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To allow multiple needleless accesses to an injection vial for the purpose of facilitating the withdrawal or addition of drugs/solutions from or to the vial.

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The provided text is an FDA 510(k) clearance letter for the "FlowArt® Valve for Vial Access". This document does not contain any information about acceptance criteria for an AI/ML device, nor does it describe a study proving such a device meets acceptance criteria.

The 510(k) is for a physical medical device (a valve for vial access), not an AI/ML software device. Therefore, it does not discuss topics such as sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

To answer your request, I would need a different document that pertains to the clearance of an AI/ML driven medical device. The current document is irrelevant to the specific questions asked as it focuses on the substantial equivalence of a physical medical device to a predicate device, and the general regulatory requirements for marketing such a device.

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