(65 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 pre-mounted on an inserter, a bone screw lock tool. and a Threading Tool. In addition, one of the following suspension sutures are provided depending on the model number: 1) a size #1 monofilament polypropylene suspension suture, 2) a size #1 monofilament polypropylene suspension suture with a radiopaque marker, 3) a size #2 monofilament polypropylene suspension suture with a radiopaque marker, or 4) a size #2 braided polyester suspension suture.
Similar to the PRELUDE III System, the ENCORE Tongue Suspension System 1) uses a bone screw, 2) uses a bone screw inserter to place a bone screw into the bone, and 3) uses a needle to pass a suspension suture submucosally through the base of the tongue. The ENCORE uses a Suture Passer and working suture loops to pass a suture from the posterior position in the tongue. The ENCORE advances the tongue in the anterior direction with a suspension suture. A Threading Tool is provided to ease passage of the suspension suture through the bone screw.
The provided text describes the 510(k) submission for the Siesta Medical, Inc. ENCORE Tongue Suspension System. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (PRELUDE III Tongue Suspension System) through performance testing, rather than a clinical study evaluating diagnostic or treatment effectiveness in humans.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Suture Endurance | "the suture was able to endure 10.5 million cycles" |
| Bone Screw to Suture Attachment Strengths | "the bone screw to suture attachment strengths were no worse than the written nominal ratings" and "the performance characteristics of the ENCORE Tongue Suspension System compare favorably to the predicate device." (Specific quantitative acceptance criteria for "nominal ratings" are not provided in the excerpt, but the favorable comparison to the predicate device implies meeting equivalence standards). |
2. Sample size used for the test set and the data provenance
The document describes device performance testing (Suture Endurance Test and Bone Screw Fixation Strength Test), not a clinical study on human subjects or a diagnostic algorithm. Therefore, "test set" in the context of clinical data or AI evaluation is not directly applicable. The "samples" would refer to the physical devices or components tested. The exact number of samples for each engineering test is not specified in the provided text, nor is their "country of origin" as they are manufactured devices. These were likely prospective engineering tests performed in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The study described is not a clinical study involving human patients or an AI device requiring expert-established ground truth. The "ground truth" here is determined by the physical properties and performance benchmarks of the medical device components themselves.
4. Adjudication method for the test set
This question is not applicable as it refers to a clinical or AI study with human interpretation, not a bench test for device performance.
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
No, an MRMC comparative effectiveness study was not performed, nor is it applicable. This is a 510(k) submission for a physical medical device, not an AI or diagnostic tool that assists human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, this question is not applicable. The ENCORE Tongue Suspension System is a physical medical device, not a standalone algorithm.
7. The type of ground truth used
The "ground truth" for the device performance tests was based on engineering specifications and established performance benchmarks derived from the predicate device and potentially industry standards for medical device materials and components. For instance:
- Suture Endurance: The acceptance criterion was enduring 10.5 million cycles, which represents a physical performance threshold.
- Bone Screw to Suture Attachment Strengths: The ground truth was described as "written nominal ratings" and "favorable comparison to the predicate device," implying a quantitative or comparative engineering standard.
8. The sample size for the training set
This question is not applicable. As previously stated, this is a 510(k) submission for a physical medical device, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable. There was no training set for an AI algorithm.
§ 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.”