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The Dual Chamber TPN Container is intended for use in the compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The Dual Chamber TPN Container can be filled either by gravity or in conjunction with automated compounding equipment.

The Dual Chamber TPN (Total Parenteral Nutrition) Container is an empty, sterile pharmacy compounding container composed of ethylene vinyl acetate (EVA). The container is divided into two chambers separated by a flexible tube and rigid separator bar. Both chambers are designed to be filled via the tubing set attached to each chamber. The upper chamber is used for filling lipid emulsion. The lower chamber is used for filling other solutions such as dextrose, amino acids, and electrolytes. Additives may be introduced via the latex-free injection/medication port present on each chamber. Once both chambers are filled, the container is stored with the flexible tube and rigid separator bar in place until the time of administration to the patient. At the time of patient use, the flexible tube and rigid separator bar are removed and the contents of the two chambers are combined. The contents are then administered to the patient using an intravascular administration set which is connected via the set port located on the lower chamber. The Dual Chamber TPN Container will be offered in three sizes: 1500 mL, 3000 mL, and 4000 mL.

This document is a 510(k) summary for the B. Braun Medical Inc. Dual Chamber TPN Container. It describes the device, its intended use, and substantial equivalence to predicate devices. It also states that the device was subjected to various tests, but it does not provide acceptance criteria or detailed study results.

Therefore, I cannot provide the requested information regarding acceptance criteria, specific device performance against those criteria, or details of a study that proves the device meets such criteria because this information is not present in the provided text.

Here's a breakdown of what can be extracted or deduced:

1. A table of acceptance criteria and the reported device performance

• Information Not Found: The document states that "The Dual Chamber TPN Container was subjected to a variety of tests to demonstrate substantial equivalence... The following tests were conducted: biocompatibility, functional performance, package integrity, shipping, impermeability to microorganisms, and chemical testing." However, it does not list specific acceptance criteria for these tests, nor does it report the device's performance against any such criteria.

2. Sample sized used for the test set and the data provenance

• Information Not Found: The document mentions that tests were conducted but does not specify sample sizes or data provenance (e.g., country of origin of data, retrospective or prospective nature of studies).

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

• Information Not Found: This information is not relevant to the type of device (a medical container) or the type of evaluations described (biocompatibility, functional performance, etc.), which do not typically involve expert readers for ground truth establishment.

4. Adjudication method for the test set

• Information Not Found: Adjudication methods are not applicable to the types of engineering and materials tests described for this device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• Information Not Found: An MRMC comparative effectiveness study is not applicable to an empty medical container. These studies are typically used for diagnostic devices with human interpretation of images or other data.

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

• Information Not Found: This device is a passive medical container; there is no "algorithm" or standalone performance in the sense of AI.

7. The type of ground truth used

• Information Not Found: The concept of "ground truth" as typically used in the context of diagnostic device evaluation (e.g., pathology, outcomes data) does not apply to the evaluation of a medical container. The evaluations performed (biocompatibility, functional performance, etc.) rely on established scientific and engineering standards and methods.

8. The sample size for the training set

• Information Not Found: This concept is not applicable as there is no "training set" for an empty medical container.

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

• Information Not Found: This concept is not applicable for the reasons mentioned above.

In summary: The provided 510(k) summary indicates that tests were conducted for the Dual Chamber TPN Container to demonstrate substantial equivalence and safety/effectiveness (biocompatibility, functional performance, package integrity, shipping, impermeability to microorganisms, and chemical testing). However, it does not provide the detailed results, acceptance criteria, or methodological specifics (like sample sizes or the involvement of human experts/ground truth establishment) that would be needed to answer your questions comprehensively. These details are typically contained in the full 510(k) submission, not the public summary.

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