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Truecare Biomedix Intravascular administration set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features. Truecare Biomedix infusion tubing may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient.

US Infusion Inc dba Truecare Biomedix Intravascular administration/extension set is sterile/pyrogen free, 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. Latex free "Y" site 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 latex free "injection port", the material shall be medical grade silicone.

This document describes a 510(k) premarket notification for Truecare Biomedix Intravascular Administration Sets. This submission focuses on establishing substantial equivalence to an existing predicate device, not on proving device performance against specific acceptance criteria through a clinical study.

Therefore, the requested information (acceptance criteria, details of a study proving criteria met, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, and training set details) cannot be extracted from the provided text.

The document primarily provides:

• Identification of the device: Truecare Biomedix Intravascular Administration Set, with various models.
• Company information: US Infusion Inc dba Truecare Biomedix.
• Classification details: Class II device, product code FPA, regulation 21 CFR 880.5440.
• Indications for Use: To deliver sterile infusion fluid from a container to the patient, with or without flow control, and as an extension of other infusion tubing.
• Design Features: Descriptions of components like universal spike, drip chamber, non-DEHP PVC tubing, flow regulator, clamps, luer locks, filters, and latex-free "Y" sites.
• Dimensional Specifications: For infusion and extension tubing.
• Materials: ABS, non-DEHP PVC, Polypropylene, Silicone.
• Substantial Equivalence Claim: Stating the device is substantially equivalent to Vitalcare 3 In 1 Intravascular Infusion Set (K050906) based on component materials, indication for use, and SAL (Sterility Assurance Level, though not explicitly defined, it's generally a key equivalence parameter for sterile devices).
• FDA Clearance Letter: Confirming the 510(k) clearance based on substantial equivalence.

In summary, the provided text is a 510(k) summary and FDA clearance letter, which aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. It does not contain information about the performance of the device against specific acceptance criteria derived from a dedicated study.

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