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IMed Technology Intravascular administration sets and Imed Technology Extension sets intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features. IMed Technology infusion tubing may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.

IMed Technology, Intravascular administration/extension set is sterile, non-pyrogenic, non-DEHP PVC tubing with the following combination of components.
a. Universal Spike. Universal spike is constructed from ABS material and has a hydrophobic vent for transfer of fluids from closed containers such as infusion bottles. The spike dimensions are variable to deliver fluid at 10, 15, 20 and 60 drops per ml. Alternatively, the spike may have a luer lock at one end which connects to non-DEHP tubing for the purposes of transporting intravenous fluids from a vial to the patient.
b. Drip chamber with 15 micron filter. The drip chamber is constructed from non-DEHP PVC or EVA, is flexible and has inbuilt 15 micron particulate disc filter which filters solution passing through it.
c. Non-DEHP PVC tubing. Variable length non-DEHP PVC tubing with differing ID/OD combinations to ensure tubing performance. Extension tubing shall have ID/OD combinations of 0.03"/0.05" (minibore), 0.01"/0.03" (microbore), various lengths; 7" to 60". Infusion tubing shall have ID of 0.1" and OD of 0.125". Various combinations of the above tubing shall be designed to deliver desired performance.
d. Flow Regulator. A commercially available dial type flow regulator may be incorporated in-line to control the flow rate of infusion fluids. The flow regulator will provide standard graduations of 5ml/hr to a maximum of 250ml/hr. The flow regulator shall be constructed from medical grade ABS and medical grade silicone disc. Optionally, a rate restricted tubing may be also incorporated in the infusion set whereby the ID and length of the tubing has been calibrated to provide a specific flow rate at gravity pressure from liquid height of 36-40"
e. Roller clamp. A roller clamp may be inserted in combination with the above components to control flow rate or to turn fluid flow on and off. Roller clamp shall be constructed from medical grade ABS plastic
f. Slide clamp. A slide clamp may be inserted in combination with the above components to turn the fluid flow on and off. Slide clamp shall be constructed from medical grade ABS material.
g. Luer locks. Female luer locks and male luer locks may be a part of the infusion set as required and shall be constructed from medical grade ABS or non-DEHP hard PVC or medical grade PP.
h. Filters. In-line air eliminating filters may be incorporated into the infusion tubing. These filters will have pore size of 0.2 micron or 1.2 micron and shall be constructed from medical grade PVC or medical grade ABS and cellulose acetate membrane.
i. "Y" site (not made with natural rubber latex) or pre-approved needleless "Y" site for secondary infusions or medication administration. The "Y" site shall be integrated in combination with the above components and shall be constructed from hard PVC or PP or ABS (all components are medical grade). In case of an "injection port" (not made with natural rubber latex), the material shall be medical grade silicone.

The provided text does not describe an AI/ML-driven medical device, but rather a standard medical device, the "IMed Technology Intravascular Administration Sets and Imed Technology Extension Set." Therefore, much of the requested information regarding AI/ML studies (like MRMC studies, training set details, and expert ground truth establishment for AI) is not applicable.

However, I can extract the acceptance criteria and the study type conducted to demonstrate the device meets these criteria based on the provided FDA 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "performance testing compliant with ISO Standards" and "ISO 8536-4:2010 tests." However, it does not specify the sample size for these tests. The data provenance is also not explicitly stated beyond being part of a medical device submission to the FDA. Given the nature of a 510(k) for a physical medical device, these would typically be bench tests conducted by the manufacturer or a contract laboratory.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as this is a physical medical device (intravascular administration set) undergoing bench testing and not an AI/ML device where expert interpretation/consensus is used to establish ground truth for algorithm performance.

4. Adjudication method for the test set:

This is not applicable for a physical medical device undergoing bench testing against ISO standards. Adjudication methods are typically relevant for human interpretation tasks or AI model outputs that require expert review.

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:

This is not applicable. This is a physical medical device, not an AI/ML system, so no MRMC study involving human readers or AI assistance would have been performed.

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

This is not applicable. This describes a physical medical device, not an algorithm.

7. The type of ground truth used:

The ground truth used for this device's evaluation is primarily engineering specifications and established international standards (e.g., ISO 8536-4:2010, ISO 10993-1) and USP Physicochemical tests. These standards define the expected performance characteristics, material properties, and safety requirements. The device's performance is measured against these objective criteria rather than expert consensus or pathology in a clinical context.

8. The sample size for the training set:

This is not applicable. This is a physical medical device, not an AI/ML system that requires a "training set."

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

This is not applicable for the same reason as point 8.

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