(202 days)
It is a prescription device intended to reduce snoring.
A prescription anti-snoring mouthpiece that is similar in design and purpose as the Samelson device. The tongue is placed at the roof of the mouth with a tongue platform holding the tongue in the forward position by a naturally occurring tongue suction and lip seal. It requires upper and lower molds. It is constructed of flexible, thermoforming mouthguard materials.
The provided text is a 510(k) summary for the NOSE BREATHE® MOUTHPIECE for HEAVY SNORER. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or a comprehensive study report for the new device.
Therefore, many of the requested elements are not explicitly available in the provided text. I will extract what is present and indicate where information is missing.
Acceptance Criteria and Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding reported device performance metrics. Instead, it relies on a qualitative assessment of "safety," "effectiveness," and "efficacy" in comparison to predicate devices.
Missing Information: Specific, quantifiable acceptance criteria (e.g., reduction in AHI, specific decibel reduction in snoring, percentage of users reporting improvement).
Here's an interpretation of what can be gleaned:
| Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|
| Safety: Device is safely used and easily removed; no dislodgment/choking episodes. | "The new device has been safely used for over four (4) years." "has not had a single episode of it happening since its inception in 1997." "All four (4) devices can be easily removed with the push of the tongue when expelling anything." "There have been no adverse effects." |
| Efficacy: Performs as intended (mitigate dry mouth, control snoring). | "All devices perform as intended." "The new device has performed well and is still being worn by the first-time users for more than four years." |
| Effectiveness: Reduces snoring. | "The predicates claim effective use of their oral devices, as does the new device in reducing snoring." "Siblings, relatives, and friends and their spouses and significant others have all benefited from the reduction in snoring." "The new device...an effective approach in reducing snoring" |
| Biocompatibility: Uses medical-grade material. | "All four (4) devices use medical grade material and have been used by the dental profession for the construction of oral devices." |
Study Details
2. Sample size 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 explicitly stated as a formal "test set." The document mentions "Siblings, relatives, and friends" and "a few hospital sleep lab patients." The number of individuals in these groups is not quantified.
- Data Provenance: The origin of the data is personal anecdotal observations (siblings, relatives, friends, spouses, significant others) and "a few hospital sleep lab patients" who were referred by their physicians. The location of these individuals is implied to be within the United States (Honolulu, Hawaii, and general references to US regulatory bodies). It appears to be a retrospective collection of anecdotal observations rather than a prospectively designed clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The "performance" claims are based on user feedback from "Siblings, relatives, and friends" and observational data from "a few hospital sleep lab patients." There's no mention of independent experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Information not provided. Given the nature of the "performance" data (anecdotal user feedback), a formal adjudication method is highly unlikely to have been employed.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with imaging or diagnostic AI, which is not relevant to this mechanical anti-snoring device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable. This device is a mechanical mouthpiece, not an algorithm. Its performance is inherently "human-in-the-loop" as it requires a user.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth Type:
- For safety and effectiveness: Primarily user-reported outcomes/satisfaction (from siblings, relatives, friends) and qualitative observations.
- For the "few hospital sleep lab patients," it's mentioned "no follow up studies have been made with the new device in place," which implies that even for these patients, formal outcome data (like AHI reduction from sleep studies) was not collected or analyzed for the purpose of this submission.
- The "ground truth" seems to be informal user feedback and the absence of reported adverse events over four years.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a medical device, not an AI/machine learning model that requires a training set. The "design" evolution involved using "many different designs and types of dental oral anti-snoring devices" which led to the current design, implying an iterative development process driven by observation rather than a formal training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no formal training set for an algorithm. The "discovery" (leading to the design) was based on observing "a pre-existing, naturally occurring lip seal and tongue suction... when the tongue is placed at the roof of the mouth," which was identified during a process of trying various designs. This is more akin to design iteration and observation than establishing ground truth for a dataset.
In summary, the provided document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and qualitative claims of safety and effectiveness, rather than quantitative performance metrics from a rigorous clinical study. The "study" mentioned for the new device is anecdotal and qualitative, involving siblings, relatives, friends, and a few sleep lab patients without formal follow-up or quantifiable data.
§ 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.”