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I.V. 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.

The Volumat Polyethylene I.V. Administration Sets (PE Sets) are available for dedicated use with the Agilia Infusion Pump and the Agilia VP MC Pump, or they can administer parenteral fluids and medications by gravity flow. Both the Agilia Infusion Pump and the Volumat I.V. Administration Sets were cleared under K121613. The Agilia VP MC Pump was cleared under K210073. The PE Sets include a spike, drip chamber, roller clamp, upstream/downstream clamp, backcheck valve, pump segment, needle-free port, rotating male luer lock, and tubing.

The provided text describes the regulatory clearance of a medical device, the "Volumat Polyethylene I.V. Administration Set," by the FDA. It does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in the format requested.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Baxter Administration Set K203609) rather than establishing novel performance metrics or conducting a clinical study with acceptance criteria.

Therefore, the specific information requested cannot be fully extracted from the provided text. However, I can provide the available information relevant to performance and testing:

Response based on available information:

The document outlines performance testing conducted to support the substantial equivalence determination by showing the device performs as intended and that differences from the predicate device do not raise new questions of safety or effectiveness. It does not explicitly state "acceptance criteria" in a quantitative table with "reported device performance" against those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of acceptance criteria with corresponding reported device performance values. Instead, it lists various standards and tests that were applied, and it states that these tests "demonstrate equivalence" or confirmed that differences "do not impact safety or effectiveness."

For example, regarding the listed technological characteristic differences:

• Operating Mechanism (presence of pumping cassette): "Difference has been verified through performance testing including flow rate accuracy under various environmental conditions (temperature, pressure, humidity) which demonstrate equivalence." (No specific flow rate accuracy acceptance criteria or results are given).
• Length: "Difference tested according to ISO 8536-4 and flow rate accuracy to demonstrate the subject device performance." (No specific length or flow rate acceptance criteria or results are given).
• Priming Volume: "Bench testing confirmed that the differences in priming volume do not impact safety or effectiveness." (No specific priming volume acceptance criteria or results are given).
• Internal/External Tube Diameter: "Difference tested to ISO 8536-8 has demonstrated equivalence." (No specific diameter acceptance criteria or results are given).
• Components (e.g., pump segment): "The differences have been verified in various aspects to demonstrate the subject device's safety and performance including: Biocompatibility testing according to ISO 10993 collateral standards, Microbial Ingress Testing, and Particulate Testing; Performance Testing according to ISO 8536-4, ISO 80369-20, ISO 8536-8 and ISO 8436-14." (No specific acceptance criteria or results for these tests are provided).

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

The document does not detail the sample sizes used for the "performance bench testing" or the specific data provenance (e.g., country of origin, retrospective/prospective). It only lists the types of tests conducted.

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

Not applicable. This information is typically relevant for studies involving human interpretation or subjective assessments, such as imaging AI algorithms. The described testing is primarily bench testing of a hardware device.

4. Adjudication Method for the Test Set

Not applicable for the type of bench testing described.

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

No MRMC study was done, as this is a physical medical device (I.V. administration set) and not an interpretive diagnostic tool or AI algorithm requiring human reader comparison. The document explicitly states: "No clinical testing was performed as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device."

6. Standalone Performance Study (Algorithm Only)

Not applicable, as this is a physical medical device, not an algorithm. The testing described is for the physical device's performance.

7. Type of Ground Truth Used

For the bench testing, the "ground truth" would be the specifications and requirements defined by the referenced ISO standards (e.g., ISO 8536-4, ISO 80369-20, ISO 8536-8, ISO 8436-14, ISO 11607-1 & 2, USP). The device's performance was compared against the pass/fail criteria within these standards to "demonstrate equivalence" and that it "performs as intended."

8. Sample Size for the Training Set

Not applicable, as this is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms.

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

Not applicable, as this is a physical medical device.

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