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The Confluent Surgical MicroMyst Applicator and Air Pump is indicated for use in the simultaneous delivery of two non- homogenous fluids or solutions onto a surgical site.

The MicroMyst Applicator and Air Pump will be configured using the following components:
Applicator with flexible tip
Air line with filter
Air Pump

The provided text is a 510(k) summary for the Confluent Surgical MicroMyst Applicator and Air Pump. This document focuses on establishing substantial equivalence to predicate devices rather than demonstrating performance against specific acceptance criteria for a novel AI/software medical device.

Therefore, many of the requested categories for AI/software medical device studies either do not apply or cannot be extracted from this document.

Here's an attempt to address the points based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary does not present specific, quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding reported device performance metrics in the way a study for an AI/software medical device would.

Instead, the "acceptance criteria" for this device's regulatory clearance is demonstrating substantial equivalence to predicate devices. The "reported device performance" is essentially that the device performs functionally similarly and safely to the predicates.

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

• Sample Size for Test Set: Not applicable/not specified. The document refers to "biocompatibility data and results of bench testing" but does not provide details on the sample size of these tests. This is not a study involving a "test set" of patient data for an algorithm.
• Data Provenance: Not applicable/not specified. Given it's bench testing and biocompatibility, concepts like "country of origin" or "retrospective/prospective" data sets for patient data do not apply.

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

Not applicable. This device is a physical medical device, not an AI/software device requiring expert-established ground truth from images or other patient data. The "ground truth" here is the physical and biological properties of the device and its function as demonstrated through engineering tests and biocompatibility assessments.

4. Adjudication Method for the Test Set

Not applicable. There is no test set in the context of expert review and adjudication for an AI algorithm.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC study was not done. This type of study is relevant for evaluating human performance with and without an AI-assisted device, which is not the subject of this 510(k).

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

Not applicable. This is a physical applicator and air pump, not an algorithm.

7. The type of ground truth used

The "ground truth" used for this device's clearance would be based on:

• Engineering specifications and performance metrics during bench testing.
• Results from biocompatibility testing (e.g., cytotoxicity, sensitization, irritation studies).
• Chemical and material characterization.
• Comparison to the established safety and performance profiles of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/software device that requires a training set.

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

Not applicable. This is not an AI/software device that requires a training set or ground truth for algorithmic training.

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