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The Confluent Surgical Dual Liquid Applicator is indicated for use in the simultaneous delivery of two non-homogeneous fluids or solutions onto a surgical site.

The Confluent Surgical Dual Liquid Applicator will be configured using the following components:
• Y-Connector
• Three Spray Tips
• Plunger Cap

The provided text describes a 510(k) submission for the Confluent Surgical Dual Liquid Applicator. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics described in the prompt's requested format.

Therefore, many of the requested categories for a study proving device meets acceptance criteria are not applicable or cannot be extracted from this particular 510(k) summary.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance:

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

• Not applicable / Not provided. The summary focuses on equivalence to a predicate device based on manufacturing, materials, and general performance data, not a direct clinical test set with human subjects or specific data provenance details. The evaluation appears to be based on design and engineering characteristics, and potentially pre-clinical (biocompatibility) data.

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

• Not applicable / Not provided. Ground truth is not established in the context of this 510(k) summary, as it's not a study designed to evaluate diagnostic accuracy or human interpretation.

4. Adjudication method for the test set:

• Not applicable / Not provided.

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. This device is a liquid applicator, not an AI-assisted diagnostic tool.

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

• Not applicable. This device is a medical instrument, not an algorithm.

7. The type of ground truth used:

• Not applicable / Not provided. The "ground truth" in this context would be whether the device physically performs its function safely and effectively, and is chemically and physically equivalent to its predicate. This is assessed through engineering tests and material comparisons, not typically a "ground truth" derived from expert consensus, pathology, or outcomes data in the way it applies to diagnostic devices.

8. The sample size for the training set:

• Not applicable / Not provided. This is not an AI/machine learning device.

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

• Not applicable / Not provided.

Summary of the Study (510(k) Submission for Substantial Equivalence):

The "study" presented here is a 510(k) premarket notification for the Confluent Surgical Dual Liquid Applicator. The objective of such a submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, rather than proving performance against independent acceptance criteria through a clinical trial or a statistically powered study as described in the prompt's questions.

How Substantial Equivalence was demonstrated:

The submission provided:

• Biocompatibility data: To ensure the materials used are safe for patient contact.
• Results of bench testing: To confirm the device's functional performance and mechanical integrity.

The conclusion states that based on this data, and based on similarities in:

• Indications for use
• Operating principle
• Component shape and dimensions
• Materials
• Manufacturing processes

The Confluent Surgical Dual Liquid Applicator was shown to be substantially equivalent to the predicate device, the DuoFlo™ Dispenser Kit (K872526).

Therefore, the "acceptance criteria" here are met by demonstrating sufficient similarity and equivalent safety/performance to the predicate device as mandated by the 510(k) regulatory pathway. Specific numerical performance targets or clinical trial outcomes in human subjects are not typically required or provided for this type of device in a 510(k) unless specific performance issues or new risks are identified.

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