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Chronic otitis media with effusion (serous, mucoid, or purulent) Recurrent episodes of acute otitis media despite conventional medical treatment . A record of persistent high negative middle ear pressure associated with one or . more of the following system: 1. Conductive hearing loss that is symptomatic 2. Persistent or recurrent otalgia 3. Persistent or recurrent vertigo, tinnitus, or both . Atelectasis resultant from retraction pocket of the tympanic membrane or . eustachian tube dysfunction.

The Grace Medical Blue PTFE (Fluoroplastic) Ventilation Tubes are manufactured from Blue (PTFE) Fluoroplastic and are supplied sterile. Various designs are available.

This document is a 510(k) premarket notification for the Grace Medical Blue PTFE (Fluoroplastic) Ventilation Tubes. It asserts substantial equivalence to predicate devices and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a performance study with acceptance criteria.

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• Chronic otitis media with effusion (serous, mucoid, or purulent) .
• Recurrent episodes of acute otitis media despite conventional medical treatment .
• A record of persistent high negative middle ear pressure associated with one or more of the . following system:
  • 1. Conductive hearing loss that is symptomatic
  • 2. Persistent or recurrent otalgia
  • 3. Persistent or recurrent vertigo, tinnitus, or both
• Retraction pocket of the tympanic membrane .

The Fluoroplastic Ventilation Tubes are substantially equivalent to the current fluoroplastic tubes marketed by Smith & Nephew, Inc., ENT Division, and the fluoroplastic tubes marketed by Xomed.

The provided text is a 510(k) summary for Fluoroplastic Ventilation Tubes. This type of document is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study with statistical endpoints.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, and training sets is not available in the provided document.

The document states:

• "The Fluoroplastic Ventilation Tubes are substantially equivalent to the current fluoroplastic tubes marketed by Smith & Nephew, Inc., ENT Division, and the fluoroplastic tubes marketed by Xomed."
• "Differences between the Fluoroplastic Ventilation Tubes and the predicate devices should not affect the safety or effectiveness."

This indicates that the main "proof" presented is the assertion of substantial equivalence based on manufacturing materials and intended use, not a clinical study demonstrating performance against a specific set of acceptance criteria.

Ask a specific question about this device