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Rio™ Vial-to-Bag Drug Reconstitution 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.

Rio™ Vial-to-Bag Drug Reconstitution Device (Rio™) is a single use, sterile, two-way, drug transfer device that is designed and indicated to connect an ICU Medical LifeCare IV container system (IV bag)(up to 250 mL) via the drug additive port, to a drug vial having a 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. RioTM design consists of a 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 having a 20mm closure. 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. Rio™ is needlefree and will passively aid in the prevention of needlestick injuries.

The provided document is a 510(k) summary for the Rio™ Vial-to-Bag Drug Reconstitution Device. It describes the device, its intended use, and compares it to a predicate device. It also mentions non-clinical testing performed to support its safety and effectiveness.

However, the document does not contain specific acceptance criteria values or detailed results of a study proving the device meets those criteria in a format that would allow for the construction of the requested table. Specifically, it lacks:

• Specific quantitative acceptance criteria: The document lists types of tests (e.g., Positive pressure leak, Fluid flow, Particulate testing) but does not provide numerical thresholds or pass/fail definitions for these tests.
• Reported device performance data: While it states "the new device met its design specifications and performs as intended," it does not provide the actual measured performance values from the tests.
• Details about sample sizes, data provenance, ground truth establishment, or expert involvement, which are typically associated with studies involving AI or complex diagnostic systems, and are not relevant to this type of mechanical medical device submission which focuses on functional and material testing.

Therefore, I cannot generate the requested table and detailed study information based on the provided text. The submission focuses on demonstrating substantial equivalence through comparison to a predicate device and extensive physical and material testing, rather than a clinical effectiveness study with human readers or AI.

Here's a breakdown of why the requested elements cannot be fulfilled from the provided text:

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated with quantitative values. The document mentions functional performance per ISO standards (e.g., ISO 8536-4, ISO 22413), particulate testing per ISO 8536-4 and USP, biocompatibility per ISO 10993-1, sterilization per ISO 11137, and packaging per ISO 11607. These standards contain acceptance criteria, but the specific criteria applied (e.g., maximum leakage rate, particle count limits) are not detailed in this summary.
   • Reported Device Performance: The document only makes a general statement that "the new device met its design specifications and performs as intended." No specific performance metrics or values are reported.

2. Sample size used for the test set and the data provenance: Not mentioned. This type of detail is typically included in full test reports, not a 510(k) summary. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of device and testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a mechanical drug reconstitution device, not an interpretative diagnostic device requiring expert ground truth establishment.

4. Adjudication method for the test set: Not applicable for this type of device testing.

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: Not applicable. This is not an AI-assisted diagnostic device.

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.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's testing would be defined by the specifications and performance requirements of the relevant ISO and USP standards for mechanical and material properties.

8. The sample size for the training set: Not applicable. This device does not use machine learning or AI that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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The Diana ChemoClave Transfer Set is a sterile, single-use closed system transfer device used for drug preparation to transfer drug from a drug vial to an IV bag for intravenous drug administration. It prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system.

Diana ChemoClave Transfer Set is intended for use with the Diana Automated Compounding System. It is a disposable, single use ancillary device for Pharmacy Compounding Devices (PCD).

The transfer set is comprised of multiple components bonded together to form a single device. These components include the following: stopcock, tubing, ChemoClave, syringe, and cassette handle. When placed in the Diana Automated Compounding System, the Diana ChemoClave Transfer Set allows the transfer of fluids from one container to the other container for reconstitution of lyophilized drug or transfer of stock drug solution to prepare medications. Connections to sourcing/receiving containers are enabled using the dedicated ChemoClave connector.

The purpose of this submission is to modify the predicate's Closed System Transfer Device (CSTD) from ChemoLock to ChemoClave, as an alternative to be used with Diana Automated Compounding System.

The provided text pertains to a 510(k) premarket notification for a medical device called the "Diana ChemoClave Transfer Set." The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report with specific acceptance criteria and performance data in a quantitative manner that would be typical for an AI/ML device.

However, I can extract the types of tests conducted and list them as criteria that the device must have met to achieve substantial equivalence. The document does not provide numerical performance data against these criteria, but rather states that the tests were conducted and the device meets functional claims.

Here's an interpretation based on the provided text:

Acceptance Criteria and Device Performance

The document describes various performance tests conducted to demonstrate the safety and effectiveness of the Diana ChemoClave Transfer Set and its substantial equivalence to the predicate device. The "acceptance criteria" are implied to be that the device passes these tests, thereby meeting functional claims and ensuring safety and efficacy consistent with the predicate.

Missing Information: It's important to note that this document does not contain the specific numerical acceptance criteria or the reported device performance values for each test. For instance, it lists "Fluid Flow" as a test but doesn't specify a required flow rate (e.g., X ml/minute) or the measured flow rate of the Diana ChemoClave Transfer Set. It merely states that the functional testing was conducted.

Study Details for Device Performance

The document describes the various studies performed to demonstrate equivalence, but does not provide details on sample sizes, provenance, expert qualifications, or adjudication methods as these are not typically included in a 510(k) summary for this type of medical device (non-AI/ML).

Here's an analysis based on your specific questions:

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

   • See table above for the types of acceptance criteria (tests) and the implied reported performance ("passed" or "meets functional claims"). Specific numerical acceptance limits and measured performance values are not provided in this document.

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

   • Not specified. The document mentions various tests (Functional, Biocompatibility, Microbial Ingress, etc.) but does not provide details on the number of units tested (sample size) for any of these studies.
   • Data Provenance: Not explicitly stated, but the submission is from ICU Medical, Inc. based in Lake Forest, Illinois, USA. It's typical for such testing to be conducted in-house or by contract labs in the company's country of origin or a region with accredited testing facilities. The document refers to FDA guidance and international standards, implying adherence to regulated testing environments.

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 an AI/ML device where "ground truth" established by experts is a primary element of performance validation in the way it would be for diagnostic algorithms. Device performance is determined by meeting physical, chemical, and biological specifications through laboratory testing.

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

   • Not applicable / none specified. Adjudication methods like 2+1 or 3+1 are used for reconciling expert opinions in diagnostic AI/ML studies. This document describes physical, chemical, and biological testing governed by established standards, not expert adjudication.

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. This is not an AI/ML device, so MRMC studies and "human readers improving with AI assistance" are not relevant or performed for this product.

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

   • No. This is not an AI/ML algorithm. Its "standalone" performance refers to its physical and functional attributes as a mechanical device. The listed tests (Fluid Flow, Leakage, Biocompatibility, Sterility, etc.) represent its standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Benchmarking against established technical standards and specifications. For this type of device, "ground truth" comes from meeting pre-defined physical, chemical, and biological specifications as outlined in harmonized standards (e.g., ISO, ASTM, USP) and FDA guidance documents. For example, "Non-pyrogenic" means it passed specific tests to confirm absence of pyrogens, which is the "ground truth" for that characteristic.

8. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of machine learning.

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

   • Not applicable. This device does not involve a "training set" or a corresponding "ground truth" establishment process for machine learning.

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