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The Frontal Sinus Trephination Cannula is indicated for patients with sinus disease that require frontal sinus irrigation or repeated frontal sinus irrigation for up to thirty days.

The device consists of a cannula and an occlusion plug.

This medical device submission for the "Frontal Sinus Trephination Cannula" is a 510(k) premarket notification, which establishes substantial equivalence to existing predicate devices rather than proving safety and effectiveness through clinical trials with acceptance criteria. As such, the provided text does not contain any information about:

• Acceptance criteria or reported device performance
• Sample sizes or data provenance for test sets
• Number or qualifications of experts for ground truth
• Adjudication methods
• MRMC comparative effectiveness studies
• Standalone algorithm performance
• Type of ground truth used
• Sample size or ground truth establishment for training sets

The document focuses on:

1. Device Description: It details the device (cannula and occlusion plug).
2. Intended Use: Specifies its indication for frontal sinus irrigation for up to thirty days.
3. Substantial Equivalence (Predicate Devices): It identifies two predicate devices:
   • Medtronic Xomed Frontal Sinus Mini-Trephine Set irrigation cannula (for the trephination aspect).
   • Vansonnenberg Chest Drainage Tubes (K925176) and common peritoneal catheters (for the short-term indwelling aspect as an introduction/drainage catheter).
   • Bard Medical's Catheter Plug (for the occlusion plug).
4. Regulatory Classification: States the device's classification as Class I with specific product codes (77KBF, 79GBX).
5. FDA Clearance Letter: The letter from the FDA confirms substantial equivalence to legally marketed predicate devices and permits the device to be marketed, subject to general controls.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, and performance metrics because this type of information is not typically part of a 510(k) submission focused on substantial equivalence for a Class I device.

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