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1. Treatment of pharyngocutaneous fistulas following laryngectorny or laryngoesophagectorny.

2. Management of cervical esophageal and hypopharyngeal strictures and fistulas resulting from a variety of causes including surgery, radiation, advanced malignancy, trauma, and ingestion of caustic agents.

The Montgomery Salivary Bypass Tube is a silicone tube with a funnel-shaped end for use in treating esophageal strictures and fistulas. The tube is available is sizes 8mm, 10mm, 12mm, 14mm, 16mm, 18mm, and 20mm (outside diameter).

This document is a 510(k) summary for a medical device called the "Montgomery Radiopaque Salivary Bypass Tube." It describes the product, its intended use, and indicates that it passed cytotoxicity testing.

However, the provided text does not contain any information regarding acceptance criteria, device performance metrics (like sensitivity, specificity, accuracy), or any details about a study evaluating its effectiveness or a comparative effectiveness study involving AI or human readers.

Therefore, I cannot fulfill your request for information about acceptance criteria, device performance, study details, expert involvement, or ground truth establishment based on the provided input. This document focuses on the regulatory submission aspects for a traditional medical device, not a diagnostic or AI-driven system that would typically have such performance metrics reported.

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