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The Precision Delivery Infusion Sets are intended to administer or aspirate fluids. These devices may be used with any patient population with consideration given to the procedure being performed and fluids being infused.

Ouest Medical's Precision Delivery Infusion Sets are single use, disposable, extension sets used to deliver fluids to a patient. The Precision Delivery Sets consist of various configurations, which includes tubing, filter, clamp, needleless connector and luers.

This document is a 510(k) premarket notification for a medical device (infusion sets). It does not describe an AI/ML medical device, therefore, the requested information about acceptance criteria and study proving the device meets the criteria in the context of AI/ML performance is not present.

The document discusses substantial equivalence to a predicate device based on non-clinical performance testing. It explicitly states that clinical testing was not performed to support this 510(k) submission and that no human-in-the-loop, multi-reader multi-case (MRMC) comparative effectiveness study, or standalone algorithm performance study was conducted.

Therefore, I cannot provide the requested information regarding:

1. Table of acceptance criteria and reported device performance (in the context of AI/ML metrics). The acceptance criteria mentioned are related to physical and chemical properties of the infusion set (e.g., priming volume, flow rate, bond strength, filter efficiency, biocompatibility, sterilization) rather than AI/ML performance metrics.
2. Sample size for the test set and data provenance. No such test set for AI/ML performance is described.
3. Number of experts and their qualifications for ground truth. No ground truth establishment related to AI/ML is mentioned.
4. Adjudication method. Not applicable.
5. MRMC comparative effectiveness study and effect size. Stated as "Not applicable. Clinical testing was not performed."
6. Standalone (algorithm only) performance. Not applicable.
7. Type of ground truth used. Not applicable in the AI/ML context.
8. Sample size for the training set. Not applicable.
9. How ground truth for the training set was established. Not applicable.

The document focuses on demonstrating that the "Precision Delivery Infusion Sets" are substantially equivalent to a previously cleared predicate device by comparing their indications for use, design features, materials, and non-clinical performance data.

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