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For the administration of blood, blood components or solutions from a container into the patient's vascular system through a vascular access device.

The proposed device is an IV Administration Set (Blood Administration Set). It is a single use, non-pyrogenic, sterile disposable device intended for the administration of fluids from a container into the patient's vascular system. It can be used to administer solutions, blood, blood products to patients of all ages ranges - neonatal, pediatric, and adult.

The proposed set consists of non-DEHP PVC (< 0.1% DEHP) tubing, a notch clamp, a female Luer lock, a non-vented cap for a female Luer lock, a male Luer lock, and a filter vented cap for a male Luer lock.

The provided text describes the regulatory filing for a medical device called a "Blood Administration Set" (K210335) by Baxter Healthcare Corporation. It details the device's indications for use, technological characteristics, and substantial equivalence to a predicate device, as well as a list of nonclinical tests performed to support its safety and effectiveness.

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

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

Biocompatibility Tests:

Sterility Tests:

Shelf-Life:

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

The document does not explicitly state the sample sizes for each of the nonclinical tests. It refers to "risk analyses and design verification tests" and "bench tests" conducted by Baxter Healthcare Corporation. The data provenance is internal to Baxter Healthcare Corporation, indicated by "Baxter Healthcare Corporation conducts risk analyses and design verification tests". There is no information regarding the country of origin of the data or whether the studies were retrospective or prospective, as these are nonclinical bench tests on the device itself.

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 section is not applicable as the studies described are nonclinical (bench) tests on the device's physical and functional properties, not clinical studies involving human patients or expert interpretation of medical data. Therefore, no "ground truth" was established by experts in a healthcare context.

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

This section is not applicable for the same reasons as point 3. Adjudication methods are relevant for clinical studies where human interpretation or expert consensus is required for complex outcomes.

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 section is not applicable as the device is a "Blood Administration Set," a physical medical device, not an AI software/algorithm requiring human reader evaluation. There is no mention of AI or human reading in the context of this device.

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

This section is not applicable as the device is a physical medical device, not an AI algorithm.

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

For the nonclinical tests, the "ground truth" or reference standards are the specified international and national standards (e.g., ISO 80369-7, ISO 1135-4, USP <788>, USP <85>, USP <161>, ISO 10993 series, ANSI/AAMI/ISO 11137 series) that the device must comply with. These standards define the acceptable performance parameters.

8. The sample size for the training set

This section is not applicable. The context is the regulatory filing for a physical medical device, not a machine learning model. There is no concept of a "training set" for the type of nonclinical tests performed for this device.

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

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

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