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To access and treat the frontal recesses, sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

The XprESS Multi-Sinus Dilation Tool is intended to remodel or recreate the sinus outflow tract via trans-nasal balloon dilation. The XprESS device combines features of a curved suction tip and a frontal ostium seeker with the tissue expansion effect of balloon dilation. The familiar features of this device enable a physician to track the device to the sinus ostium using endoscopic visualization. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses within the same patient.

The XprESS Multi-Sinus Dilation Tool has been tested to withstand multiple inflations and device tip manipulations (up to 25) in a surgical case wherein all 6 sinus ostia are being dilated.

The XprESS device curved suction tip has a 2 mm atraumatic ball tip with a 1 mm inside diameter. A suction tube may be connected to the proximal barbed fitting to provide active suction.

The XprESS Multi-Sinus Dilation Tool is provided sterile and for single use only.

The items packaged with the Xpress Multi-Sinus Dilation Tool include the Inflation Device and the Infusion Line.

Here's an analysis of the provided text regarding the acceptance criteria and study for the XprESS Multi-Sinus Dilation Tool (K102003):

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria in a pass/fail format. However, it describes performance testing conducted to ensure design specifications were met and the device performed as intended.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The text mentions a "cadaver study" but does not specify the number of cadavers used.
• Data Provenance: The cadaver study is presumably a prospective study conducted for the purpose of this submission. The country of origin is not explicitly stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number or qualifications of experts involved in establishing ground truth for the cadaver study. It's likely that a surgeon or medical professional familiar with sinus anatomy and procedures would have performed or overseen the procedures in the cadaver study.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the cadaver study.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a performance study on a cadaver model, not a comparative study involving human readers or clinical outcomes.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The XprESS Multi-Sinus Dilation Tool is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" doesn't apply. The performance study was for the device itself.

7. The Type of Ground Truth Used

For the cadaver study, the "ground truth" would have been the direct anatomical observation of the sinus outflow tracts after dilation using the device. This would involve visual inspection and potentially physical measurements or dissections within the cadaver to confirm that the remodeling or recreation of the sinus outflow tract occurred as intended.

8. The Sample Size for the Training Set

This question is not applicable. This device is not an AI/ML algorithm that requires a "training set." The term "design verification testing" covered various engineering tests for the device's physical properties and function.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no "training set" for this type of medical device. The "ground truth" for the device's design specifications would have been established through engineering design requirements, material specifications, and functional targets determined by the manufacturer.

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