(196 days)
OASYS Oral Airway System is intended for use to reduce or eleviate snoring and obstructive sleep apnea.
The OASYS ORAL AIRWAY SYSTEM Anti-Snoring Device is composed of:
- Lower tray fitted over the lower teeth.
- Upper shield fitting in front of upper anterior teeth.
- Upper molded splint fitted over upper teeth.
- Connecting mechanism joining upper shield and lower tray.
- Extensions off shield which act as nasal dilators.
The provided document for the "OASYS-ORAL AIRWAY SYSTEM" (K030440) does not contain detailed acceptance criteria or a specific study proving the device meets quantitative performance metrics. This is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to predicate devices rather than proving novel safety and effectiveness through extensive clinical trials with predefined acceptance criteria.
The document primarily highlights the device's technical characteristics and intended use, comparing them qualitatively to predicate devices. There are no quantifiable performance metrics, sample sizes, expert ground truth details, or statistical analyses typically associated with proving acceptance criteria.
Therefore, I cannot populate the requested table and answer the study-related questions quantitatively based on the information provided. The document specifically states: "Literature supports the historical significance of oral devices that reposition the mandible and reduce and manage snoring as well as sleep apnea." This implies reliance on existing knowledge and predicate device performance rather than dedicated efficacy studies for this specific device in this submission.
However, I can extract information related to the device's intended use and the comparison to predicate devices, which implicitly serves as the "acceptance criteria" in a 510(k) context – demonstrating that the new device is as safe and effective as existing legally marketed devices.
Summary of Information from the Provided Document (K030440):
Since no specific acceptance criteria with quantifiable metrics and associated study data are presented in this 510(k) summary, I will interpret "acceptance criteria" in the context of a 510(k) submission as the attributes and intended uses for which the device needs to demonstrate substantial equivalence to its predicates. The "reported device performance" would then be its conformance to these attributes and uses as stated in the comparison.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Attribute/Intended Use) | Reported Device Performance (OASYS K030440) |
|---|---|
| Intended Use: | |
| Indicated as an intraoral device | Yes |
| Intended to reduce or help snoring | Yes (stated, and implied by comparison to predicates with this indication) |
| Indicated for use with persons who snore | Yes (stated, and implied by comparison to predicates with this indication) |
| Indicated to reduce or alleviate obstructive sleep apnea (OSA) | Yes (stated, and implied by comparison to predicates with this indication) |
| Indicated for single patient, multi-use | Yes |
| Indicated for use at home or sleep laboratories | Yes |
| Design Characteristics: | |
| Heat sensitive impressible material for fitting to teeth | Yes |
| Custom fit for each user | Yes |
| Can be adjusted or refit | Yes |
| Placed in users mouth each evening | Yes |
| Cleaned daily | Yes |
| Easily removed from mouth | Yes |
| Permits user to breathe through mouth | Yes |
| Prevents grinding of teeth | Yes |
| Materials: | |
| Heat sensitive impression material | Yes |
| Rigid tray | Yes |
| Non-Sterile | Yes |
| Safety and Effectiveness: | The submission states: "This difference [nasal dilators] does not have a significant effect on the safety or effectiveness of the device." and "Literature supports the historical significance of oral devices that reposition the mandible and reduce and manage snoring as well as sleep apnea." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document does not mention any specific test set, sample size, or data provenance from a study conducted for this device. The submission relies on demonstrating substantial equivalence to predicate devices and general literature support for oral appliances.
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)
No test set is described, and therefore, no information is provided regarding experts or their qualifications for establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No test set is described, and therefore, no information on adjudication methods is provided.
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 MRMC study was conducted or reported in this 510(k) submission. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was conducted or reported. This device is a mechanical oral appliance, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
No specific ground truth type is mentioned as no dedicated study data is presented for this device's performance. The submission relies on the established safety and effectiveness of predicate devices and general scientific literature on oral appliances for snoring and sleep apnea.
8. The sample size for the training set
No training set is described, as this is a mechanical device submission and not an AI/algorithm submission.
9. How the ground truth for the training set was established
No training set is described, and therefore, no information on how ground truth was established for a training set is provided.
§ 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.”