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The Disposable Infusion Bag for Parenteral Nutrition is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set.

The device is not intended to store the fluids for 24 hours or greater.

The proposed device is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The proposed device is provided sterile and single use.

The proposed device is available in 7 series due to different bag capacities, different tube locations and different tube materials.

The provided text describes the 510(k) premarket notification for the "Disposable Infusion Bag for Parenteral Nutrition" (K222622) and compares it to a predicate device (K101412). However, it focuses on non-clinical tests and does not include information about clinical studies with human readers or AI performance metrics. Therefore, several sections of your request cannot be fulfilled by the provided document.

Here's an analysis based on the available text:

1. Table of acceptance criteria and the reported device performance

The document lists performance standards met by the proposed device, which serve as acceptance criteria. The "reported device performance" is a statement that the device complied with these standards. Specific numerical results or detailed performance metrics are not provided in this summary.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria consists of a series of non-clinical tests conducted by the manufacturer, Beijing L&Z Medical Technology Development Co., Ltd. These tests aimed to verify that the proposed device met all design specifications and complied with established international and US national standards relevant to medical devices, particularly for I.V. containers.

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

The document does not specify sample sizes for each non-clinical test performed. It generally states that "Non clinical tests were conducted," implying that an appropriate number of samples were tested to achieve statistical confidence for each standard.

• Sample sizes: Not specified in the provided summary.
• Data provenance: The tests were conducted by the manufacturer, Beijing L&Z Medical Technology Development Co., Ltd., which is located in Beijing, P.R. China. The tests are non-clinical, meaning they involve laboratory or bench testing rather than human subjects. They are inherently prospective in the context of device development and verification.

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

This section is not applicable as the described study is a non-clinical device performance test, not a study involving interpretation by human experts or ground truth in the context of diagnostic performance (e.g., radiology). The "ground truth" here is adherence to the specified technical and biological safety standards.

4. Adjudication method for the test set

This section is not applicable for the same reason as point 3. Adjudication methods are relevant for subjective interpretations, typically in clinical studies or when establishing ground truth from expert opinions.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (infusion bag), not an AI-powered diagnostic or assistive technology. Therefore, there is no information on human reader improvement with or without AI assistance.

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

No, a standalone algorithm performance study was not done. This device is not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for this device's performance is defined by the established international and national standards (e.g., ISO 15747, ASTM F1886, ISO 10993 series, USP ) and the specific design specifications of the device. The compliance with these objective, measurable standards constitutes the "ground truth" that the non-clinical tests were designed to verify.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no training set in the context of data used to train a model.

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

Not applicable. As there is no training set for an algorithm, there is no ground truth established for one.

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