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IV Administration Set for the infusion of parenteral fluids and medications from a container into the patient's vascular system through a vascular access device with Agilia VP MC/Volumat MC Agilia pump or gravity only.

Transfusion Set for the infusion of blood derivatives from a container into the patient's vascular system through a vascular access device with Agilia VP MC/Volumat MC Agilia pump or gravity only.

The Volumat 100 Line is available for dedicated use with the Volumat MC Agilia Infusion Pump and the Agilia VP MC Pump, or they can administer parenteral fluids and medications by gravity flow. Both the Volumat MC Agilia Infusion Pump and the Volumat I.V. Administration Sets were cleared under K121613, and the Agilia VP MC Pump was cleared under K210073. The Volumat TM Line components include a spike, drip chamber, roller clamp, upstream/downstream clamp, backcheck valve, pump segment, upstream filter, needle free port, rotating male luer lock, luer lock connector, Yconnector, tubing, and burette.

The provided text is a 510(k) summary for the Fresenius Kabi Volumat™ Line, an Intravascular Administration Set. This document primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing and biocompatibility testing, rather than a clinical study involving human readers or AI algorithms.

Therefore, many of the requested details, such as MRMC studies, human reader improvement with AI, ground truth establishment for training and test sets, number of experts, and adjudication methods, are not applicable to this device submission as it is a physical medical device (IV administration set) and not an AI/ML-driven diagnostic or therapeutic device.

However, I can extract the relevant information regarding acceptance criteria and the studies performed to demonstrate the device meets these criteria.

Device: Volumat™ Line (Intravascular Administration Set)
Submission Type: 510(k) Premarket Notification (K220301)
Predicate Device: Baxter Administration Set (K203609)

The acceptance criteria for this type of device are primarily based on established performance standards for IV administration sets, ensuring safety and effectiveness through physical, chemical, and biological compatibility. The "study" proving the device meets these criteria is a series of bench tests and biocompatibility evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a direct table of "acceptance criteria" with specific pass/fail values for each test. Instead, it lists the types of tests and applicable ISO standards used to demonstrate that the Volumat™ Line performs as intended and is as safe and effective as the predicate device. The implicit acceptance criterion for each test is successful compliance with the respective standard.

General Acceptance Principles (Implied from the document):

• Functional Equivalence: The device must perform its intended function (infusion of fluids/medications/blood products) safely and accurately.
• Physical Integrity: The device components must withstand operational stresses without leakage, cracking, or separation.
• Biocompatibility: The materials used must be safe for patient contact.
• Sterility: The device must be sterile and maintain sterility until use.
• Compatibility: The device must be compatible with its intended use environment (e.g., infusion pumps, gravity flow).

Reported Device Performance:
The document states that all performance testing and design control activities were "conducted and has confirmed that the different technological characteristics of the proposed devices do not raise different questions of safety and effectiveness." It explicitly states that the device was found to be "at least as safe and effective as the legally marketed predicate device" and "substantially equivalent."

While specific numerical performance results are not provided in this public summary, the successful completion of the listed tests implies that the device met the established acceptance criteria for each standard.

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

The document does not specify the exact sample sizes for each bench test. For physical device testing, sample sizes are typically determined by relevant industry standards (e.g., ISO, ASTM) and statistical methods to ensure representativeness and confidence in results.

• Data Provenance: This is bench testing of a physical medical device. The tests were performed to support a 510(k) submission to the FDA. The country of origin for the testing is not specified, but the applicant (Fresenius Kabi) has locations in Germany (address listed) and the USA. The testing would be prospective in the sense that it was conducted specifically to support this regulatory submission for the new device.

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

Not Applicable. This is a physical medical device. The "ground truth" for evaluating its performance is established by validated test methods and international standards (ISO, ASTM, USP), not by human expert opinion (e.g., radiologists interpreting images). The "experts" involved would be engineers, material scientists, and quality assurance professionals performing and reviewing the test results against the specified standards.

4. Adjudication Method for the Test Set

Not Applicable. There is no "adjudication" in the sense of multiple human evaluators reviewing outputs. The objective performance is measured against predefined pass/fail criteria from the standards.

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

No. MRMC studies are typically performed for diagnostic devices (e.g., AI algorithms for image interpretation) to evaluate the impact of the device on human reader performance. This is a physical IV administration set.

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

Not Applicable. This is not an algorithm-based device. "Standalone performance" in this context refers to the device's ability to meet its functional specifications independently, which was assessed through the various bench tests.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is derived from established international standards and validated test methods.

• Functional Performance Standards: ISO 8536-8, ISO 80369-20, ISO 8536-4, ISO 8536-14, USP.
• Biocompatibility Standards: ISO 10993 series.
• Sterilization Standards: ISO 11135.
• Packaging Standards: ISO 11607-1, ASTM D4169.

These standards define the expected performance thresholds (e.g., maximum leakage, acceptable tensile strength, no cytotoxicity) against which the device's measured performance is compared.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device that requires a "training set" in the computational sense. The device's design and manufacturing processes are developed based on engineering principles and regulatory requirements.

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

Not Applicable. As there is no "training set" for an AI/ML model, there is no corresponding ground truth establishment process for a training set. The "ground truth" for the device's design and manufacturing are the established engineering principles, material science knowledge, and regulatory standards for medical device safety and efficacy.

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The Agilia VP Infusion System is intended for adult and pediatric care for the intermittent or continuous delivery of parenteral fluids, medications, blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, subcutaneous and intraosseous using dedicated administration sets.

The Agilia VP Infusion System is also intended for neonatal care for the intermittent or continuous delivery of parenteral fluids for hydration and nutrition, blood derivatives through clinically accepted parenteral routes of administration. These routes of administration include intravenous, intra-arterial, and subcutaneous using dedicated administration sets.

It is intended for use by trained healthcare professionals in healthcare facilities.

The Agilia VP Infusion System includes the Agilia VP MC WiFi Volumetric Infusion Pump, which is a programmable electronic medical system dedicated to administering a pre-determined volume of an infusion product at a programmed rate, in combination with Volumat Line administration sets and optional accessories. The optional accessories are identified as follows:

• Agilia Link 4, 6 and 8 Stacking rack system intended to power and organize 4, 6 or 8 pumps at the patient bedside.
• Agilia Duo two-channel accessory designed to power two Agilia infusion pumps.
• Agilia USB Cable - intended to connect the Agilia VP infusion pump to a PC for serial communication.

The provided document is a 510(k) summary for the Fresenius Kabi Agilia VP Infusion System. This document focuses on demonstrating substantial equivalence to a predicate device (Agilia Infusion System (K121613)), rather than proving the device meets specific acceptance criteria based on a clinical study evaluating its diagnostic or therapeutic performance (like an AI/CADe device).

Therefore, the requested details specific to a study that proves the device meets acceptance criteria (especially for AI/CADe devices, such as sample size, ground truth, expert adjudication, MRMC studies, standalone performance, training set details) are not applicable (N/A) in this context.

This submission relies on non-clinical testing and comparison to a predicate device to establish safety and effectiveness.

Here's an analysis of the document regarding acceptance criteria and the methods used to prove substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria with reported numerical performance values in the way one would for a diagnostic AI device (e.g., sensitivity, specificity thresholds). Instead, it relies on demonstrating similarity to a predicate device and showing conformance to industry standards and internal design verification/validation testing.

The "acceptance criteria" are implied by:

• Substantial Equivalence: The primary "acceptance criterion" for a 510(k) submission is to demonstrate that the new device is as safe and effective as a legally marketed predicate device.
• Conformance to Standards: Meeting the requirements of relevant electrical safety, EMC, and usability standards (e.g., IEC 60601-1, IEC 62366-1).
• Verification and Validation Testing: This implicitly means the device performs according to its design specifications.
• Reliability Goals: The device met its internal reliability goals.

Implied Acceptance Criteria and Reported Performance (from comparison table and non-clinical testing section):

The following points are N/A for this type of 510(k) submission which is for an infusion pump, not an AI/CADe device.

2. Sample size used for the test set and the data provenance: N/A (No clinical test set for diagnostic performance)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No ground truth establishment for diagnostic performance)

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

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

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (Ground truth in this context would refer to engineering specifications and performance measurements against those specifications, rather than clinical ground truth for diagnostic accuracy)

8. The sample size for the training set: N/A (Not an AI/ML device in the context of diagnostic algorithms; "training set" would relate to internal engineering development and testing, not a formal clinical data training set for an AI model)

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

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