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Baxter is currently marketing a line of empty Viaflex® plastic containers used for the preparation and administration of drug admixtures. We propose to change the materials of the container sheeting, administration and medication ports and medication site and market the container under the tradename IntraVia™ Container, Empty.

Baxter is currently marketing a line of empty Viaflex® plastic containers used for the preparation and administration of drug admixtures. We propose to change the materials of the container sheeting, administration and medication ports and medication site and market the container under the tradename IntraVia™ Container, Empty.

The primary reason for the change in container materials is to allow a change in sterilization methods from ETO to gamma sterilization. In addition, use of the including use of standard thermoplastic methods for recycling and reduction in the amounts of environmental contaminants released during incineration of PVC such as hydrochloric acid and dioxins. The material change in the medication site is being made to improve user safety by eliminating the potential for sensitivity reactions associated with natural rubber proteins.

The provided text describes a 510(k) Premarket Notification for the IntraVia™ Empty Plastic Container, which is a medical device. However, the nature of this device (an empty plastic container for drug admixtures) does not involve diagnostic or interpretative tasks that would typically be evaluated with the metrics and study designs (like MRMC, standalone AI performance, ground truth establishment by experts, etc.) you've asked about.

Therefore, many of the specific questions regarding acceptance criteria and studies are not applicable in the context of this type of medical device filing. The acceptance criteria for this device focus on material safety, functional performance, and drug compatibility rather than diagnostic accuracy.

Here's how the information provided relates to your questions:

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

Based on the provided text, the acceptance criteria are implicit in the "Discussion of Nonclinical Tests" and "Summary of Technological Characteristics." The reported performance indicates these criteria were met.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text does not specify sample sizes for any of the tests (biological, physicochemical, functional, or drug compatibility). It also does not explicitly state the provenance of data (e.g., country of origin, retrospective or prospective), although such non-clinical testing is typically conducted in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. For an empty plastic container, "ground truth" as it relates to expert interpretation (like in diagnostic imaging) is not relevant. The "ground truth" for this device is established by objective laboratory measurements and adherence to specified standards (ISO, USP).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods are relevant for subjective expert review in diagnostic studies, not for objective laboratory testing of a container's physical and chemical properties.

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 question is not applicable. An MRMC study is designed for evaluating diagnostic devices (e.g., AI algorithms for interpreting images) where human readers are involved. This device is an empty plastic container, not a diagnostic tool or an AI-assisted system.

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

This question is not applicable. This device is not an algorithm or an AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this device, the "ground truth" is defined by:

• Compliance with established standards: ISO 10993-1 and USP Physicochemical tests for material safety.
• Objective functional measurements: Residual volume, fill volume, spike insertion/removal force, burst testing, measured against specified engineering and performance requirements.
• Chemical stability and compatibility tests: Assessed by laboratory analysis of drug-container interactions under controlled conditions.

8. The sample size for the training set

This question is not applicable. There is no "training set" in the context of developing an empty plastic container. This concept applies to machine learning models.

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

This question is not applicable as there is no training set for this device.

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