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The Sinexus Sinus Stent Gen 2 is intended for use in adult patients following sinus surgery to maintain patency of the sinus by separating mucosal tissues, providing stabilization of the middle turbinate and preventing obstruction by adhesions between healing and/or inflamed mucosal surfaces.

The Gen 2 Sinexus Sinus Stent is a bioabsorbable stent designed to be placed in the ethmoid sinus to maintain patency of the sinus after surgery.

The provided text is a 510(k) summary for the Sinexus Sinus Stent Gen 2. This document is a regulatory submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device. It primarily focuses on comparing the new device's intended use, technological characteristics, and materials to existing devices, and often summarizes performance testing to support claims of safety and effectiveness.

However, the provided text does not contain the detailed study information required to fill out the table and answer all the questions about acceptance criteria and device performance as it would for a software device or a diagnostic device. The 510(k) summary for a medical device like a stent typically focuses on material safety, mechanical properties, biocompatibility, and perhaps animal or limited human trials to show it performs its intended function similarly to predicate devices. It does not typically involve metrics like sensitivity, specificity, or reader performance improvement, which are common for AI/ML-based diagnostic devices.

Therefore, I cannot populate most of the requested fields directly from the provided text. I will indicate where the information is not available.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text. (e.g., country of origin, retrospective or prospective)

3. 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)

Not applicable or not specified in the provided text. For a physical device like a sinus stent, "ground truth" establishment in the context of expert consensus or pathology is typically not a central part of a 510(k) summary, which often relies on in-vitro, ex-vivo, or limited clinical data.

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

Not applicable or not specified in the provided text.

5. 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

Not applicable. This is a physical medical device (stent), not an AI/ML diagnostic or assistive technology for human readers.

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

Not applicable. This is a physical medical device (stent), not an algorithm.

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

Not explicitly specified in the provided text. For a device like this, ground truth would likely refer to clinical outcomes (e.g., maintained patency, absence of adhesions) observed in human or animal studies, or validation against engineering and biocompatibility standards. The 510(k) relies on comparison to predicate devices, implying that their established safety and effectiveness serve as a benchmark.

8. The sample size for the training set

Not applicable or not specified in the provided text. The concept of a "training set" in the context of AI/ML is not relevant here for a physical medical device. Performance testing for a stent would involve mechanical tests and potentially biological studies, not training data.

9. How the ground truth for the training set was established

Not applicable or not specified in the provided text due to the nature of the device and the submission document.

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