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For the administration of fluids from a container into the patient's vascular system through a vascular access device.

The proposed devices consist of IV Extension sets and IV set accessories. They are single use disposable devices intended for the administration of fluids from a container into the patient's vascular system. They are non-pyrogenic, sterile devices that can be used with or without a syringe. The extension sets consist of PVC tubing or polyethylene lined PVC tubing, a notch clamp, female luer, non-vented cap, male luer, and filter vented cap. They are used to administer solutions, drugs, antibiotics, lipids to the patient. The accessories consists of an anti-siphon valve, back check valve, and 1.2 µm Filter. They attach to the proposed sets to add a specific feature to facilitate the administration of fluid when used with a syringe. The anti-siphon valve reduces the risk of free flow from the syringe and backflow into the primary infusion line. The back check valve prevents backflow into the primary infusion line. The 1.2 um Filter prevents particulate matter and eliminates air bubbles.

The provided document is a 510(k) Summary for Baxter Healthcare Corporation's Intravascular Extension Sets and Accessories (K192366). It describes a Class II medical device intended for the administration of fluids into a patient's vascular system.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various tests conducted and generally states that "All tests met the acceptance criteria" without providing specific numeric results for each test. The acceptance criteria themselves are primarily referenced by external standards, not internal performance metrics.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for the individual performance tests (e.g., Luer tests, tensile strength, leak test, etc.). It only states that tests were conducted.

The data provenance is retrospective testing performed by Baxter Healthcare Corporation to verify the functional performance of the proposed devices. No information about the country of origin of the data is provided beyond the submitting company being U.S.-based (Illinois).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable to this type of device submission. The tests are bench tests verifying physical and chemical properties of the device, not clinical performance requiring expert medical review or ground truth establishment in a diagnostic context.

4. Adjudication Method for the Test Set

This section is not applicable. As mentioned above, the tests are primarily bench tests against engineering standards, not subjective assessments requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images or data. The device in question is an intravenous extension set and accessories, which are physical medical components.

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

This section is not applicable. The device is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the performance tests, the "ground truth" or reference is established by the acceptance criteria outlined in various international standards (e.g., ISO, BS EN ISO) and Baxter's internal test methods. For biocompatibility, it's the biological response against established toxicology and biocompatibility standards. For sterility, it's the validation against a specified Sterility Assurance Level (SAL).

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical medical device. There is no "training set" in the context of an algorithm or AI system. The manufacturing process and quality control would involve ongoing sampling and testing, but not in the sense of a machine learning training set.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reasons as point 8.

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