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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 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 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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