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Baxter's Infusor SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated for patients requiring slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications at a constant flow rate. The device is also indicated for the administration of bolus doses of medication upon patient demand when used in conjunction with the Patient Control Module. It is suitable for use in the hospital or home setting.

Baxter's Infusor SV devices are single-use, disposable elastomeric infusion pumps designed to deliver solution at a constant preset flow rate ranging from 0.5mL/hr to 5mL/hr, depending on device configuration. The modifications made to the Infusor SV devices include replacing the glass restrictor tube and housing used in previous versions of the device with a plastic tubing flow restrictor, a coupler to connect the tubing flow restrictor to the tube set and a Luer lock connector.

Given the provided text, the device in question is the "Infusor SV Elastomeric Infusion Device," which is an infusion pump. The document describes modifications made to this device and provides information on its conformity to safety and effectiveness through nonclinical testing.

Here's an analysis based on your requested information:

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

2. Sample size 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 specific sample sizes used for the mechanical, biocompatibility, and flow rate tests. It only mentions that "Design verification tests...were performed to verify the modifications" and that "Testing of the device and components included mechanical, biocompatibility, and flow rate testing."

The provenance of the data is not specified (e.g., country of origin, retrospective/prospective). This is a 510(k) summary for a modified medical device, and the focus is on demonstrating equivalence to predicate devices through engineering and bench testing, rather than clinical trial data.

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 document describes nonclinical testing for an infusion pump. Therefore, there is no mention of experts or qualifications for establishing ground truth as this is not a study involving human-interpreted diagnostic outcomes. The "ground truth" for this device would be established by objective measurements against engineering specifications and regulatory standards.

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

Not applicable. As this is a nonclinical study involving engineering and bench testing of an infusion pump, there is no mention of an adjudication method used for a test set. Adjudication methods are typically relevant in clinical studies or studies involving subjective human interpretation of data where consensus among experts might be required.

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 type of study is relevant for diagnostic imaging devices involving human interpretation, often in the context of AI assistance. This document is for an infusion pump and focuses on confirming the safety and effectiveness of a device modification through nonclinical bench testing.

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

Not applicable. The device is an elastomeric infusion pump, not an algorithm or AI-driven system. Therefore, the concept of "standalone (algorithm only)" performance does not apply. The performance evaluated here is the physical device's ability to maintain specific flow rates and its mechanical and biocompatibility properties.

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

For the nonclinical tests (mechanical, biocompatibility, and flow rate testing), the "ground truth" would be established by predetermined engineering specifications, regulatory standards, and established test protocols. For example, for flow rate testing, the "ground truth" would be the expected constant flow rate (e.g., 0.5mL/hr to 5mL/hr) against which the device's actual delivery is measured. For biocompatibility, it would be compliance with relevant ISO standards for materials.

8. The sample size for the training set

Not applicable. This submission describes modifications to an existing physical medical device (an infusion pump), not a machine learning or AI algorithm. Therefore, there is no concept of a "training set" in the context of this 510(k) submission.

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

Not applicable. As there is no training set for an AI/ML algorithm, the question of how its ground truth was established is not relevant to this document.

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