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The Naväge Nose Cleaner is intended to help relieve nasal and/or sinus congestion and stuffiness by washing and moisturizing the nasal cavity with a pressure-controlled stream of irrigant rinse.

The Naväge Nose Cleaner ("Naväge") is a powered nasal irrigator intended for OTC use to wash and moisturize the nasal cavity. There are many nasal irrigation devices in commercial distribution in the US, and Naväge is substantially identical to those devices in terms of intended use and indications for use. It is similar in terms of mechanical functionality with the single exception that in addition to using positive pressure, Naväge simultaneously uses negative pressure (suction). That is, the device uses a combination of positive pressure (gravity) to introduce irrigant rinse into the nasal cavity, and negative pressure (powered suction) to aspirate the rinse out of the nasal cavity. The simultaneous use of positive and negative pressure makes it possible for the device to be self-contained so that after washing through the nasal cavity, the irrigant rinse can flow into a removable collection tank attached to the device. This provides an improved nasal irrigation experience resulting from functional simplicity, superior ergonomics, and less mess than currently available devices.

The provided text describes the Naväge Nose Cleaner and its substantial equivalence to predicate devices, focusing on its functional characteristics rather than clinical performance or AI integration. Therefore, many of the requested categories related to acceptance criteria, study design for AI models, ground truth, and expert evaluation are not directly available in this document.

However, I can extract information related to the device's performance specifications and the studies conducted to demonstrate substantial equivalence for certain aspects.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the typical sense of a pre-defined threshold for clinical efficacy but rather performance specifications for mechanical operation and demonstrations of equivalence for usability and safety.

Study Details

The document refers to studies conducted to demonstrate substantial equivalence, but it does not detail the methodology for all of them.

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

   • Flow Rate and Pressure Performance Data: No specific sample size or data provenance (country of origin, retrospective/prospective) is provided for the "Performance testing data for flow rate of irrigant and pressure." This likely refers to engineering bench testing rather than human subject data.
   • Comprehension Study: No specific sample size or data provenance is provided for the "comprehension study of the subject device's Instructions for Use."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The performance testing appears to be objective mechanical measurements, not dependent on expert ground truth in a clinical sense. The comprehension study likely involved consumer participants rather than experts establishing a "ground truth."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable based on the information 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: Not applicable. This device is a physical medical device (nasal irrigator), not an AI diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For flow rate and pressure: The "ground truth" would be the objective measurements obtained from laboratory equipment.
   • For biocompatibility: Compliance with ISO 10993 parts 5 and 10 constitutes the basis for determining biocompatibility.
   • For electrical safety: Compliance with IEC-60601-1 constitutes the basis for determining electrical safety.
   • For consumer comprehension: The "ground truth" would likely be the scores or performance on consumer comprehension tasks.

8. The sample size for the training set: Not applicable. The device is not an AI model requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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