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The SinuFlush Lavage System is intended for nasal and sinus irrigation in patients who are under the care of a physician. The SinuFlush Lavage System is a prescription use product that is to be used by adults in either the physician's office or in the home after obtaining instructions from a health care provider.

The SinuFlush Lavage System is a hand held 25 cc syringe with a plunger to control the force of delivery and volume markings on its side in order to measure the amount of irrigant to be delivered. The tip consists of soft silicone to occlude the nasal ostium during irrigation. The mixing container consists of a 25 cc container with markings on its side for volume measurement in cc, and a plastic screw top to secure the contents of the container during shaking.

This 510(k) summary does not contain information on acceptance criteria, a study proving device performance against such criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or training/test set ground truth details. The document focuses on regulatory submission for a medical device (SinuFlush Lavage System) and its substantial equivalence to a predicate device (Sinusense Nasal Rinse).

The provided text is a 510(k) summary for a medical device, the SinuFlush Lavage System. It outlines the device description, its intended use, and its comparison to a predicate device. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed device rather than presenting detailed performance studies against specific acceptance criteria like those found for AI/ML-driven devices.

Therefore, the following information is not present in the provided text:

• A table of acceptance criteria and the reported device performance: This document does not establish specific performance metrics or acceptance criteria beyond demonstrating substantial equivalence to a predicate device in terms of intended use, principle of operation, and nose contact mechanism.
• Sample size used for the test set and the data provenance: No test set or related performance data is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set requiring expert ground truth is mentioned.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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: This device is a manual lavage system, not an AI-assisted diagnostic or treatment device, so MRMC studies are not relevant.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for this type of manual device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
• How the ground truth for the training set was established: Not applicable.

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