(140 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 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, 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, and 4) a size #2 braided polyester suspension line.
Similar to the predicate ENCORE System, the modified ENCORE Tongue Suspension System 1) uses a bone screw, 2) a bone screw inserter to place a bone screw into the bone, and 3) 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 to anterior position in the tongue. The ENCORE advances the tongue in the anterior direction with a suspension line. A Threading Tool is provided to ease passage of the suspension line through the bone screw.
The provided text describes a medical device submission (K121814) for the Siesta Medical, Inc. ENCORE Tongue Suspension System. This submission is for a modification to an existing device (predicate device K111179).
The document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission does not typically include detailed studies proving specific performance criteria and clinical efficacy in the same way a PMA (Premarket Approval) would. Instead, it focuses on demonstrating equivalence to a device that has already been cleared.
Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available in this 510(k) summary. The summary explicitly states: "This submission supports the position that the Siesta Medical, Inc. modified ENCORE Tongue Suspension System is substantially equivalent to the predicate ENCORE Tongue Suspension System (K111179). The 510(k) includes a test report to support extension of the shelf-life to 2 years."
Here's what can be inferred or explicitly stated from the provided text, while also noting what is absent:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for the modified device. The primary "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to a predicate device in terms of intended use, operating principle, technology, and manufacturing process.
- Reported Device Performance: The document only mentions a "test report to support extension of the shelf-life to 2 years." This is a specific performance claim related to durability/stability, but no other performance metrics (e.g., success rate of tongue advancement, reduction in AHI, or adverse event rates) are provided for the modified device in this summary.
| Acceptance Criteria (Implied for 510(k) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate | Stated to be substantially equivalent in intended use, operating principle, technology, and manufacturing process. |
| Shelf-life | Extended to 2 years (supported by a test report). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document only refers to "a test report to support extension of the shelf-life." This likely refers to bench testing, not a clinical test set on patients.
- Data Provenance: Not specified. Given it's a shelf-life test, it would typically be laboratory-based rather than patient-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. This information is typically relevant for studies involving subjective human assessment (e.g., image interpretation), which is not the type of data presented in this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically for clinical trials or diagnostic accuracy studies where multiple observers or subjective assessments are involved.
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 a surgical implant for tongue suspension, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the shelf-life extension, the "ground truth" would likely be objective measurements of material degradation or functional performance over time, according to established engineering and material science standards. No clinical ground truth is discussed for the modified device itself.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not a machine learning or AI device.
Summary of what the K121814 submission does provide:
- It states the device's intended use: "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."
- It claims substantial equivalence to the predicate device (K111179) in terms of intended use, operating principle, technology, and manufacturing process.
- It specifically mentions "a test report to support extension of the shelf-life to 2 years" as a new piece of supporting data for the modification.
- It provides a detailed description of the device components and how they function, highlighting similarities to the predicate.
This 510(k) notification is primarily a regulatory filing to demonstrate that a modified device is as safe and effective as a previously cleared device, rather than a clinical study establishing new performance metrics for an entirely novel device. Therefore, the detailed study information sought is typically not part of these submissions.
§ 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.”