(85 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) 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, the following suspension lines are provided depending on the model number: 1) #2 braided polyester suspension line and 2) #2 braided polyethylene suspension line.
This document describes the Encore System, an intraoral device for treating obstructive sleep apnea (OSA) and snoring, and its substantial equivalence to a predicate device. The primary focus of this submission (K213159) is on updated MRI safety information and a minor drill bit length modification, rather than a clinical study evaluating the device's therapeutic effectiveness for OSA or snoring. Therefore, comprehensive acceptance criteria and a study proving therapeutic efficacy are not detailed in this 510(k) summary.
However, based on the provided text, we can infer the acceptance criteria for the MRI safety update and the corresponding testing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (for MRI Safety) | Reported Device Performance (from summary) |
|---|---|
| Safe for MRI scanning under specified conditions. | Encore Bone Screw may be safely scanned under specified conditions (1.5T to 3T, specific spatial field gradient, RF excitation, RF coil type, SAR, and scan duration). |
| Image artifact within acceptable limits. | The presence of this implant may produce an image artifact of 12mm. |
| No significant risk to patient in MRI environment. | Performance testing confirmed that the implantable metallic components do not pose a significant risk to a patient in a clinical MRI environment under the conditions presented in the labeling. |
2. Sample size used for the test set and the data provenance
The document describes non-clinical testing regarding MRI safety. Therefore, there is no "test set" of patient data in the context of clinical outcomes. The "sample size" would refer to the components tested in the MRI safety experiments. The document does not specify the exact number of components or systems tested.
- Data provenance: Non-clinical testing for MRI compatibility. The country of origin for this testing is not specified, but it would typically be conducted by a certified testing lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. As this is non-clinical MRI safety testing, there are no human experts establishing "ground truth" in the clinical sense. MRI safety evaluations typically rely on established testing standards and protocols interpreted by engineers and physicists specializing in MR compatibility.
4. Adjudication method for the test set
N/A. There is no clinical test set requiring adjudication in this context. The MRI safety testing follows standardized protocols, and results are typically evaluated against pre-defined thresholds.
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
N/A. This 510(k) submission is for an intraoral device, not an AI or imaging diagnostic device. Therefore, an MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
N/A. This 510(k) submission is for an intraoral device, not an algorithm.
7. The type of ground truth used
For the MRI safety testing, the "ground truth" is defined by established international standards (e.g., ASTM F2052, ASTM F2182) and the physical properties of the materials and device. The acceptance criteria are derived from these standards and generally accepted safety limits for MRI.
8. The sample size for the training set
N/A. This is a non-clinical MRI safety evaluation, not a machine learning or AI algorithm development.
9. How the ground truth for the training set was established
N/A. See point 8.
§ 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.”