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The Encore System is intended for anterior advancement of the tongue base and hyoid suspension. It is indicated for the treatment of obstructive sleep apnea (OSA) and / or snoring.

The Encore System is designed for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone and hyoid bone suspension to the mandible bone using a bone screw and suspension lines. The Encore System consists of 1) an integrated suture passer pre-loaded with size #2-0 braided polyester suture, 2) three (3) bone screws and two (2) bone screw inserters, 3) a suspension line lock tool, 4) a threading tool, and 5) a drill bit. In addition, a #2 braided polyethelene suspension line is provided. All components are provided sterile.

This document is a 510(k) Pre-Market Notification from the FDA regarding the Siesta Medical Encore System. It's a regulatory clearance document and does not contain the detailed study results, acceptance criteria, or performance metrics typically found in a clinical study report.

Therefore, I cannot provide the requested information, which includes a table of acceptance criteria and reported device performance, sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, details of MRMC studies (effect size), standalone performance, or ground truth establishment.

The document states:

• The device is the Encore™ System.
• Intended Use: Anterior advancement of the tongue base and hyoid suspension for the treatment of obstructive sleep apnea (OSA) and/or snoring.
• Change: The current submission (K201238) introduces a #2 braided polyethylene suspension line (vs. #2 braided polyester in the predicate K183310).
• Non-Clinical Testing: A "Suture Tensile Strength Test" was conducted.
• Conclusion of Testing: The results "confirmed that the strength of the #2 braided polyethylene suspension is similar to that of the existing #2 braided polyester suspension line."

This type of submission typically relies on demonstrating substantial equivalence to a predicate device, focusing on a specific change (in this case, the material of the suspension line) and ensuring that the new material does not negatively impact the device's fundamental function or safety. The "Suture Tensile Strength Test" is the evidence provided to support this claim, indicating that the new suspension line has comparable strength to the old one.

Without further documentation, it is impossible to fulfill the request for detailed study information.

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