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

The Confluent Surgical MicroMyst Applicator will be configured using the following components: Applicator Air line with Filter Air Source

The provided text describes a 510(k) summary for the Confluent Surgical MicroMyst Applicator and Air Pump and its clearance by the FDA. However, it does not contain any information regarding acceptance criteria, device performance metrics, or details of a study that would prove the device meets specific acceptance criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Confluent Surgical MicroMyst Applicator and Air Pump K050998) based on similar technological characteristics, indications for use, operating principle, design, materials, and manufacturing processes. It states that "Testing conducted to characterize performance of the proposed device incorporating the modification discussed in this submission has demonstrated that it is substantially equivalent to the predicate device and that it is suitable for the intended use specified." but provides no details about this testing.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number and qualifications of experts for ground truth establishment
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. How ground truth for the training set was established

This document is a regulatory submission for device clearance based on substantial equivalence, not a detailed study report with performance metrics against pre-defined acceptance criteria.

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