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GCMEDICA Mini Transfer Device, GCMEDICA Vial Transfer Device: Intended for the aseptic dispensing of solutions from IV containers. For use in transferring IV fluids/medication from a vial to an IV fluid administration device. GCMEDICA Bag Transfer Device, GCMEDICA Clear Bag Transfer Device: 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 Decanting Device is provided as sterile and is intended for use in a single procedure only. There are four proposed models: GC0652DD, GC 0653DD and GC0654DD and GC0654 DT. Model GC0652DD, GC0654DD and GC0654 DT consist of spike and cap for spike. Model GC0653DD consists of Protective Cap, Needle Tip, Cover and stick.

Through the use of a spike/stick, facilitates creation of a sterile fluid path. Decanting device help ensure an aseptic transfer or removal of fluids/medication from flexible and rigid containers.

For models GC0653DD and GC0652DD, insert the decanter spike/stick by piercing the rubber opening of the glass vial. Tilt the decanting device body until desired flow is reached, ensuring the spike/stick air ventilation holes remain inside the glass vial.

The provided text is a summary of a 510(k) premarket notification for GCMEDICA transfer devices. It primarily focuses on demonstrating substantial equivalence to a predicate device through performance testing and biocompatibility testing. The document does not describe a clinical study in the way typically expected for software or AI medical devices (i.e., with acceptance criteria related to accuracy, sensitivity, specificity, etc., or human reader studies).

It confirms that no clinical study was included in this submission (Section 5.9). Therefore, it's not possible to provide information related to AI performance, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance.

Here's an analysis based on the information provided, focusing on the device's functional and safety acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the successful passing of various bench and biocompatibility tests. The "reported device performance" is the statement that all tests "were passing."

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

This is not applicable as there was no clinical study or test set of patient data in the typical sense for AI/software. The "test set" refers to physical device samples used for bench and biological testing. The document does not specify the exact number of units tested for each benchmark test, only that "The results of all testing were passing." The provenance is "internal standards."

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

Not applicable. Ground truth for these types of physical device tests typically involves standardized measurement instruments and validated laboratory procedures, not expert interpretation of diagnostic data.

4. Adjudication Method

Not applicable, as there was no expert review or human interpretation of diagnostic data.

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

No. The submission explicitly states, "No Clinical Study is included in this submission."

6. Standalone (Algorithm Only) Performance Study

No. This device is a physical medical device (transfer device), not a software or AI algorithm.

7. Type of Ground Truth Used

For biocompatibility: Recognized international standards (ISO 10993 series).
For performance bench testing: Internal standards, USP for particulate matter, and ISO 11135-1:2014 for sterilization.

8. Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve AI or algorithms that require a "training set."

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

Not applicable, for the same reason as point 8.

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