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SinuSys Vent-Os® Sinus Dilation family is intended to provide a means to access the sinus ostia and associated spaces in adults for diagnostic and therapeutic procedures.

• The Vent-Os Maxillary Dilation System is indicated for dilation of Maxillary sinus and associated spaces.
• · The Vent-Os Frontal Dilation System is indicated for dilation of the Frontal recess and associated spaces.
• · The Vent-Os Sphenoid Dilation System is indicated for dilation of Sphenoid sinus and associated spaces.

The Vent-Os® Sinus Dilation family comprises a family of osmotically driven devices that access and dilate the sinus ostia and spaces associated with the paranasal sinus cavities. Each member of the Vent-Os® Sinus Dilation family is a system that includes a Dilation Device preloaded on a Placement Instrument. The Placement Instrument accesses the target site through the nasal passageway and delivers the Dilation Device. The Vent-Os® Sinus Dilation Device then expands and remodels the target tissues and then is removed.

Here's an analysis of the acceptance criteria and study detailed in the provided text.

Based on the provided text, the device in question is the "Vent-Os® Sinus Dilation Family."

Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for outcomes like "patent" rates for the clinical trial. Instead, it compares the device's performance to a literature control to demonstrate "substantial equivalence." The "acceptance criteria" can be inferred as achieving comparable safety and effectiveness to the predicate device and the literature control.

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Clinical Trial Test Set: 30 patients.
   • Data Provenance: The study was a "multi-center, prospective, single arm, non-randomized trial conducted at three (3) clinical sites." The country of origin is not explicitly stated, but given the FDA submission, it's typically understood to be within or recognized by the US regulatory framework.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document states "three (3) investigators" for the clinical trial. It implies these investigators were physicians involved in treating patients with chronic rhinosinusitis and evaluating the outcomes. Specific qualifications (e.g., years of experience, specific specialization beyond "physician users") are not detailed.
   • For cadaver testing, "multiple physician users" were involved in validating usability.

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

   • The document does not describe any specific adjudication method for the clinical outcomes. It implies the "investigators" assessed the success of the treatment, but details on how agreement was reached for indeterminate cases or divergences in assessment are not provided.

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 MRMC comparative effectiveness study was done. This device is a surgical instrument, not an AI-assisted diagnostic tool for human readers.

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

   • This is not applicable as the Vent-Os® Sinus Dilation Family is a surgical instrument and not an algorithm or AI system.

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

   • For the clinical trial, the outcomes (patent, non-patent, indeterminate) appear to be based on clinical assessment by the physician investigators (outcomes data) at the 3-month follow-up. This type of assessment often relies on endoscopic evaluation and investigator judgment.
   • For cadaver testing, the ground truth was expert observation/confirmation of successful delivery and placement by "multiple physician users."

7. The sample size for the training set:

   • As this is a surgical device and not an AI or machine learning model, there is no "training set" in the conventional sense. The development of the device would involve engineering, material science, and iterative testing, but not data-driven training of an algorithm.

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

   • Not applicable, as there is no training set for an AI/ML algorithm.

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