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510(k) Data Aggregation
(161 days)
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) bone screws and two (2) bone screw inserters, 3) a suspension line lock tool, and 4) a threading tool. In addition, the following suspension lines are provided depending on the model number: 1) a #2 monofilament polypropylene suspension line with a radiopaque marker, 2) a size #2 braided polyester suspension line, and 3) a size #2 braided polyester suspension line with a radiopaque marker.
Here's a breakdown of the acceptance criteria and study information for the Encore System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Biocompatible, same materials as predicate device | Biocompatible, same materials as predicate device (Pass) |
| Bench Testing - Suspension Line Endurance | Pass | Pass |
| Bench Testing - Bone Screw-to-Suspension Line Fixation Strength | Pass | Pass |
| Bench Testing - Tether Loop Strength | Exceeds suture loading force | Exceeds suture loading force, resulting in acceptable low risk category (Pass) |
| Clinical Performance (AHI Reduction) | Significant reduction in Apnea Hypopnea Index (AHI) for severe OSA, comparable to predicate. | 61.8% AHI reduction for Encore System (similar to 57.8% for AIRvance System). |
| Clinical Performance (Complications) | Complications similar to predicate devices. | Complications are similar between the subject and predicate devices. |
| Safety and Effectiveness | Modified intended use does not adversely affect safety and effectiveness. | Medical literature supports safety and efficacy for proposed intended use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The clinical performance was assessed through a literature review of 377 total patients across 16 studies. For the Encore System specifically, 45 patients from 2 studies were included.
- Data Provenance: The data is from a literature review of peer-reviewed clinical studies. The document does not specify the country of origin but implies various clinical settings where these studies were conducted. The data is retrospective, drawn from existing published research.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the provided text describes a literature review of existing clinical data rather than a study involving a prospectively collected test set with ground truthing by experts. The "ground truth" here is the reported clinical outcomes in the published studies.
4. Adjudication Method for the Test Set
This information is not applicable as the data is from a literature review of already published clinical studies, not a new test set requiring expert adjudication.
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
This information is not applicable. The device described is a medical implant (the Encore System) for treating sleep apnea, not an AI-assisted diagnostic or treatment planning tool that would involve human readers or AI assistance in the way typically seen in image analysis or diagnostic AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. The device is a physical medical implant, not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the clinical performance assessment was derived from outcomes data reported in peer-reviewed clinical studies, specifically the Apnea Hypopnea Index (AHI) reduction and complication rates. For the bench testing, the ground truth was established by passing specified engineering and materials tests (e.g., "Pass" criteria for endurance and fixation strength).
8. The Sample Size for the Training Set
This information is not applicable. The context is the evaluation of a medical device (implant) and not the training of a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above (not an AI/ML context).
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