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The largest patient population are children between 4 months and 6 years of age (but not exclusively). Otological ventilation tubes are indicated for patients with:

• Chronic or recurrent otitis media with persistent effusion (OME).
• Recurrent acute otitis media.
• Acute otitis media with complications.
• Eustachian tube dysfunction resulting in one or more of the following: significant and symptomatic hearing loss, otalgia, vertigo, and tinnitus.
• Hearing loss resulting from bilateral chronic middle ear effusion.

Neozoline Ventilation Tubes

The provided document is an FDA 510(k) clearance letter for the "Neozoline Ventilation Tubes" and does not contain information regarding detailed acceptance criteria, device performance studies, or ground truth establishment relevant to AI/ML device evaluation. It is a regulatory document stating that the device is substantially equivalent to a predicate device for its indicated uses.

Therefore, I cannot provide the requested information from this document. The document primarily focuses on:

• Device Name: Neozoline Ventilation Tubes
• Regulation Number/Name: 21 CFR 874.3880, Tympanostomy Tubes
• Regulatory Class: Class II
• Product Code: ETD
• Indications for Use: Chronic or recurrent otitis media with persistent effusion (OME), Recurrent acute otitis media, Acute otitis media with complications, Eustachian tube dysfunction (resulting in hearing loss, otalgia, vertigo, tinnitus), and Hearing loss from bilateral chronic middle ear effusion.
• Target Population: Largest patient population are children between 4 months and 6 years of age (but not exclusively).

To answer your questions about acceptance criteria and device performance studies, a different type of document (e.g., a clinical study report, a comprehensive technical report, or a detailed submission summary that includes performance data) would be required.

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