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The MicroMyst Applicator is indicated for use in the simultaneous delivery of two non-homogenous solutions onto a surgical site.

The MicroMyst Applicator will be configured using the following components: Applicator (14cm long, multi-lumen shaft that provides separate channels for the flow of two fluids and filtered air) Air line with filter (a poly (vinyl chloride) tubing with an integral 0.2 µL filter; the free end of this tubing connects to a flow source or flow-regulator)

The provided text is related to a 510(k) submission for a medical device called the "MicroMyst Applicator." However, it focuses primarily on regulatory approval and equivalence to a predicate device, and does not contain the detailed information required to answer the specific questions about acceptance criteria and a study proving device performance as outlined in your prompt.

The document highlights:

• Device: MicroMyst Applicator
• Indication for Use: Simultaneous delivery of two non-homogenous solutions onto a surgical site.
• Safety and Effectiveness: Stated to be demonstrated through biocompatibility and in vitro bench testing, supporting substantial equivalence to a predicate device.
• Conclusion: The device is substantially equivalent to a predicate device based on safety and effectiveness data, same indications for use, and same operating principle.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about a study that proves the device meets specific performance criteria from the provided text. The document describes a regulatory submission for a device, not a performance study with detailed methodology, results, or ground truth establishment.

To answer your questions accurately, I would need a document that describes:

• Specific performance metrics for the device (e.g., flow rate accuracy, mist uniformity, delivery precision).
• Quantifiable acceptance criteria for those metrics.
• Details of a study (e.g., bench testing, clinical trial) that measured these metrics.
• The results of that study compared to the acceptance criteria.
• Information on sample sizes, ground truth establishment, expert involvement, and statistical methods.

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