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This device is equivalent to an IV set and is utilized to transfer fluids from a container to a patient's intravascular access catheter. The device offers the capability of high flow rates which may be desirable in emergency trauma treatment.

In accordance with section 510(k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce The CombiPort Emergency Infusion Device. This device is equivalent to an IV set and is utilized to transfer fluids from a container to a patient's intravascular access catheter. The device offers the capability of high flow rates which may be desirable in emergency trauma treatment.

This submission describes a medical device, the CombiPort Emergency Infusion Device, which is an I.V. fluid transfer set. However, the provided text does not contain any information regarding acceptance criteria, a specific study proving device performance against those criteria, or any details related to AI/ML or diagnostic performance studies.

Therefore, I cannot fulfill the request to describe the acceptance criteria and study that proves the device meets them, nor can I provide information on sample sizes, ground truth, expert qualifications, or MRMC studies, as these concepts are not addressed in the provided document.

The document primarily focuses on:

• 510(k) Summary: A regulatory declaration for market clearance.
• Device Description: What the device is and its intended use (transferring fluids from a container to a patient's intravascular access catheter, with high flow rates for emergency trauma).
• Substantial Equivalence: Comparing it to a previously cleared device (IV Fluid Transfer Pin, K925401) by the same applicant.
• Material Safety: Stating that materials are tested according to ISO Standard 10993.
• Safety and Effectiveness (General Statement): Mentions that finished products are tested and must meet release specifications, including physical testing and visual examination, defined by Quality Control Test Procedure documents.

The "Safety And Effectiveness" section mentions "required release specifications" and "physical testing, visual examination." While these are indications of quality control, they are not presented as a formal study with specific acceptance criteria and detailed performance results that would be used to objectively "prove" clinical effectiveness or diagnostic accuracy in the way described in your prompt (which usually applies to software, AI/ML, or more complex diagnostic devices).

In summary, based only on the provided text, the requested information cannot be extracted.

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