Search Results

The Empty Fluid Container is used to hold an admixture of compatible fluids for intravenous administration to a patient. Medication transfer in and out of the container is done using aseptic technique.

The eZSURE™ Empty Fluid Container (EFC) devices are empty single-use, sterile, nonpyrogenic flexible IV container devices/ bags. These are discarded after use. The Subject EFC device is composed of a flexible plastic film bag and two separate ports with closures, one for injection and another, infusion. An inlet-/ entry-/ additive- port is used for filling one or more compatible fluid(s) into the bag by a transfer set/ syringe without needle, and another port, the spiking/ administration port, is used for accessing the infusate in the bag with a standard bag spike. A transfer device with a male luer lock is used to connect to the filling-/ additive- port for filling. The additive port incorporates a needle-free valve; hence no injection needle/ cannula is needed. The transfer device is removed at the end of the preparation step, and the needle-free self-sealing additive-/ injection-/ filling- port secures the admixture contents until their administration. For administration to a patient, the device is then connected to an external IV set /IV line, via a bag spike. The IV bag is piped by inserting the spike point of a bag spike into the spiking-/administration- port of the IV bag, doing this by performing a twisting motion. When the bag is already filled, other medications can be added using the additive/ injection/ filling port, even during administration. Medication transfer in and out of the container is done using aseptic technique. The bags range in volume capacity of 100 mL, and 500 mL. The device has a hanger hole so it can be placed on an IV bag holder. The EFC is made of non-PVC materials and provided in a two-port configuration: The needle free additive port which is used for filling the container and the other, the spiking -/ administration port, which is used for IV therapy administration from the EFC. The EFC sub-components are externally communicating devices with no contact to the blood path. The contact duration is categorized as B-prolonged, (>24h to 30d), per ISO 10993-1 :2018 biocompatibility guidelines.

The provided text is a 510(k) Summary for a medical device called eZSURE™ Empty Fluid Container. It does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance, multi-reader multi-case studies, or the establishment of ground truth by experts.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device for a Class II medical device (an empty IV fluid container). The "acceptance criteria" and "study" described in the document relate to physical and biological performance testing of the container itself, not the performance of an AI algorithm in diagnostic imaging.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to AI.
• Sample sizes, data provenance, number/qualifications of experts, or adjudication methods for an AI test set.
• MRMC comparative effectiveness study details.
• Standalone AI performance details.
• Training set size or ground truth establishment for an AI.

The document describes the following types of acceptance criteria and studies for the physical medical device:

1. A table of acceptance criteria and the reported device performance (for the physical device, not AI):

The document does not provide a single, consolidated table directly mapping acceptance criteria to quantitative performance results for each test. Instead, it lists the types of tests performed and states that the device "met their respective acceptance criteria" or "complies with" relevant standards.

Summary of Acceptance Criteria and Reported Performance (extracted from Section VII):

2. Sample size used for the test set and the data provenance:
The document does not specify exact sample sizes for each test listed. It mentions "testing done" and "test methods" but not the number of units tested. Data provenance is not applicable here as it refers to physical testing of a manufactured device, not clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the "ground truth" for this device's performance relates to physical and biological properties (e.g., whether it leaks, whether materials are biocompatible, whether it is sterile), which are established through standardized laboratory testing, not by expert human readers interpreting data.

4. Adjudication method for the test set:
Not applicable for physical/biological performance testing.

5. If a Multi-reader Multi-case (MRMC) comparative effectiveness study was done:
No, this type of study is for evaluating diagnostic performance of imaging devices or AI, which is irrelevant to an empty fluid container.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as there is no AI algorithm being evaluated for this physical device.

7. The type of ground truth used:
For the physical device, the "ground truth" is defined by the technical specifications and performance limits set by various ISO, ASTM, ANSI/AAMI, EN, and USP standards (e.g., a certain burst pressure, a specific level of particulate matter, absence of microbial growth).

8. The sample size for the training set:
Not applicable, as this is not an AI model requiring a training set.

9. How the ground truth for the training set was established:
Not applicable, as there is no AI model or training set.

In conclusion, the provided FDA 510(k) summary is for a standard medical device (an empty fluid container) and demonstrates its substantial equivalence based on physical, chemical, and biological performance testing, rather than the performance of an AI algorithm.

Ask a specific question about this device