(205 days)
The Siesta Medical, Inc. ENCORE Tongue Suspension System is intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with suture. It is indicated for the treatment of mild or moderate obstructive sleep apnea (OSA) and /or snoring.
The ENCORE Tongue Suspension System is designed for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone using a bone screw and suture. The ENCORE Tongue Suspension System consists of an integrated suture passer pre-loaded with size #2-0 braided polyester suture, a titanium bone screw that is premounted on an inserter, a suspension line lock tool, and a Threading Tool. In addition, the following suspension lines are provided depending on the model number: 1) a size #1 monofilament polypropylene suspension line, 2) a size #1 monofilament polypropylene suspension line with a radiopaque marker, 3) a size #2 monofilament polypropylene suspension line with a radiopaque marker, 4) a size #2 braided polyester suspension line, and 5) a size #2 braided polyester suspension line with a radiopaque marker.
This document describes the 510(k) submission for the Siesta Medical, Inc. ENCORE™ Tongue Suspension System, emphasizing its substantial equivalence to a predicate device. The information provided focuses on non-clinical testing and explicitly states that no clinical testing was performed for this submission. Therefore, many of the requested details related to clinical studies, human reader performance, and ground truth establishment are not available in this text.
1. Table of Acceptance Criteria and Reported Device Performance
Since this submission pertains to a modification of an existing device and relies on showing substantial equivalence through non-clinical testing, specific "acceptance criteria" for clinical performance metrics (like sensitivity, specificity, or improvement in human reader performance) are not detailed. Instead, the focus is on performance specifications met through bench testing.
| Test Name | Performance Demonstrated / Reported Result | Acceptance Criteria (Implicit) |
|---|---|---|
| Suture Endurance Test | Met performance specifications | Suture should withstand expected forces and duration without failure; details of exact criteria are not provided. |
| Bone Screw Fixation Strength Test | Met performance specifications | Bone screw should maintain adequate fixation in bone; details of exact criteria are not provided. |
| Radiographic Visibility of Suspension Line Marker | Met performance specifications | Radiopaque marker should be sufficiently visible under radiography; details of exact criteria are not provided. |
| ENCORE System Removability in Chronic Porcine Model | Met performance specifications | The system should be removable in a chronic setting; details of exact criteria are not provided. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of clinical performance evaluation, as no human subject clinical testing was performed. The non-clinical tests would have used specific sample sizes for their materials/components, but these are not disclosed in this summary.
- Data Provenance: The non-clinical testing appears to be conducted by Siesta Medical, Inc. (manufacturer). No country of origin is specified for the data, but it's implied to be from the manufacturer's testing. All data is retrospective in the sense that it's from completed tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No ground truth based on expert consensus was established as no clinical study involving human assessment was conducted.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication was used.
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 device is not an AI-assisted diagnostic tool, and no MRMC study was conducted. The device is a surgical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a surgical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests would be the measurement of physical properties (e.g., tensile strength, fixation force, radiographic density) against predefined engineering specifications. This is distinct from clinical ground truth like pathology, expert consensus, or outcomes data, which are not relevant here.
8. The Sample Size for the Training Set
Not applicable. There is no training set in the context of this device's evaluation, as it is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set.
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”