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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. XprESS is offered in three balloon sizes: 5mm, 6mm and 7mm diameter balloons. 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 by covering the suction vent. An Infusion Line connected to a syringe may be connected to the proximal barbed fitting to provide irrigation. The device was designed to prevent fluid from exiting the suction vent during irrigation. 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 Infusion Line.

This 510(k) summary describes a medical device, the XprESS Multi-Sinus Dilation Tool, and its performance data. However, it does not contain the detailed information typically found in studies designed to establish acceptance criteria for AI/ML devices or studies that directly "prove" a device meets those criteria with specific statistical metrics.

The provided document is for a manual surgical instrument and the performance data presented is for design verification and simulated use in a cadaver model, not for an AI/ML algorithm.

Therefore, many of the requested categories (like MRMC studies, standalone algorithm performance, training/test set sizes, expert ground truth for AI, etc.) are not applicable to this specific device and the information provided.

However, I can extract the acceptance criteria for the design verification and the reported device performance from the provided text:

Acceptance Criteria and Reported Device Performance

Due to the nature of the device (a manual surgical instrument, not an AI/ML system), most of the subsequent questions are not directly applicable. However, I will answer them based on what can be inferred from the provided text for completeness, noting where the information is not present or relevant to AI/ML.

Additional Information (Contextualized for a Non-AI Device)

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Test Set Description: The "test set" for this device consisted of "simulated use in a cadaver model" and "design verification" which included dimensional, functional, and simulated use testing.
   • Sample Size: Not explicitly stated for the cadaver model or other tests. The durability test mentions "all 6 sinus ostia" being dilated in a surgical case, implying at least one full cadaver head or simulated model.
   • Data Provenance: Not specified, but implied to be from laboratory testing and potentially cadaver labs, likely within the US where the company is based (Maple Grove, MN). It is "prospective" in the sense that tests were conducted specifically for this submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified, but implied that the testing was overseen by product engineers, clinical experts, and regulatory personnel familiar with surgical instrument performance and medical device standards. Given the nature of a manual surgical instrument, "ground truth" is typically established by engineering specifications, validated test methods, and clinical assessment of usability/effectiveness by surgeons.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable in the context of this type of device testing. Performance is measured against engineering specifications and functional benchmarks, not through expert adjudication of output.

4. 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:

   • No, an MRMC study was not done. This is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic device that involves human "readers" or "AI assistance" in the sense of an algorithm.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • No, a standalone algorithm performance test was not done. This device is a manual surgical instrument.

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

   • The "ground truth" for this device's performance is established by engineering design specifications, industry standards (e.g., ISO 10993 for biocompatibility), and functional benchmarks observed during simulated use (e.g., ability to withstand a certain number of inflations, proper fluid flow, physical dimensions).

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is a non-AI manual surgical instrument. Device design and validation are based on engineering principles and performance testing, not machine learning.

8. How the ground truth for the training set was established:

   • Not applicable. No training set; therefore, no ground truth needed to be established for it.

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