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The main indications according to their frequency are : - 1. tracheobronchial tumors - 2. Tracheal stenosis with scarring - 3. Bronchial stenosis after surgical anastomotic, anastomoses resections or pulmonary transplantation. These stenoses have, as a common characteristic, the importance of the extrinsic compression or the collapse of the cartilingeous wall. The indication always focuses on an endoscopic therapeutic action, whether is concerns a resection or dilation. The stent insertion is indicated if the endoscopic resection is incomplete, in case of a persistent extrinsic compression, or if the lumen is insufficient. The most frequent locations are tracheal. The left main bronchus is the second location, followed by the right main bronchus.

the ENDOXANE® is an endoscopy stent made of silicone. This stent, the most fitted in the world, is presented as a silicone tube with stubs allowing to avoid any movement. The non armed polysiloxane is covered with a new coating especially designed in order to keep its' flexibility which facilitates tolerance and evacuation of secretions. A well-adapted ENDOXANE® does not move and cough reflexes are inhibited by reflex center saturation. The stubs prevent a direct contact between the stent surface and the mucus membrane and distribute the pressures among the small surfaces.

The provided document is a 510(k) premarket notification for a medical device called ENDOXANE. It describes the device, its indications for use, and claims substantial equivalence to a predicate device. However, it does not contain the detailed clinical study data, acceptance criteria, or performance metrics that would typically be required to fully answer the request.

Therefore, I can only provide the information that is available in the document and explicitly state where information is missing.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria (e.g., specific thresholds for performance metrics like sensitivity, specificity, accuracy, or complication rates) are stated in the document.

The document mentions "Complications were uncommon, usually easily manage, and rarely life threatening. The main complications were emigration (9.5%)n obstruction by secretions." This is a reported observation from a study, not a pre-defined acceptance criterion.

• Oval-shaped stents regained round shape in less than two days in cases of extreme compression
• Complications: uncommon, usually easily managed, rarely life-threatening
• Main complications: emigration (9.5%), obstruction by secretions |

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

The document refers to a study: "The conclusion that one can reach concerning our stents is best stated in the study published in "The Journal of Bronchology" (3:6-10, 1996) about the placing of 1500 stents (Cavalière, Diaz, Dumon, Vergnon)."

• Sample Size for Test Set: 1500 stents were placed (implicitly, 1500 patients or cases).
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the applicant (NOVATECH S.A.) is based in France, and the authors of the cited study (Cavalière, Diaz, Dumon, Vergnon) are likely affiliated with French institutions, suggesting the data is likely from France or Europe.
  • Retrospective or Prospective: Not explicitly stated. Given that it's a publication summarizing "placing of 1500 stents," it could be a retrospective analysis of a series of cases over time.

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)

This information is not provided in the document. The document refers to a published study, but does not detail the methodology for establishing ground truth within that study. The "ground truth" for stent performance would likely come from clinical follow-up and physician assessment, but specifics are missing.

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

This information is not provided in the document.

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

• MRMC Study: No, this is not an AI device. The ENDOXANE® is a physical medical device (tracheal/bronchial stent). This question is not applicable.

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

• Standalone Performance: No, this is not an AI device. This question is not applicable.

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

The "ground truth" implicitly refers to clinical outcomes and physician assessment of stent performance and complications from the cited study. For example, "no single case of compression was observed" and "complications were emigration (9.5%) and obstruction by secretions" are clinical outcome data. Specifics on how individual outcomes were defined and assessed are not provided in this regulatory document, but would be expected in the full journal article.

8. The sample size for the training set

• Training Set Sample Size: This is not applicable as the ENDOXANE® is a physical medical device, not an AI or software device that undergoes a "training" process in the typical machine learning sense. The device was developed and then tested.

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

• Ground Truth for Training Set: This is not applicable for the same reasons as above.

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