(166 days)
A maxillary "denture-like" mouthpiece with tongue restraint compartment to actuate mouth closure. The device is intended for use as an aid to reduce simple snoring.
It is customized for patients with or without natural teeth and for mixed dentition. Reflex action reverts to mouth breathing instantly should the nasal passages congest
A maxillary "denture-like" mouthpiece with tongue restraint compartment to actuate mouth closure.
The provided document describes a premarket notification for an "Oral Sleep Disorder Aid" and does not contain a comprehensive study with detailed acceptance criteria and reported device performance in a quantitative manner. Instead, it relies on a comparison to predicate devices and non-clinical self-observations.
Here's a breakdown of the information available based on your request, along with what is not present in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category / Comparison Point | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Efficacy | Perform as intended (reduce snoring, encourage nasal breathing). | "Total" oral snore control (non-clinical evaluation, voice-actuated tape recorder at bedside) unless interrupted by nasal congestion. "Definite success" in trial subjects. |
| Safety | No dislodging leading to choking; safe use. | Safely used by applicant for over 5 years. Precision occlusal match and snug tongue restraint compartment contribute to stability. Can remain seated or be expelled with a push of the tongue in case of nasal congestion or vomiting. Coughing or sneezing causes no problem. |
| Material Biocompatibility | Use medical grade material, similar to those used in prosthetic oral devices. | Uses medical grade material; used by dental profession for prosthetic oral devices (same as predicates). |
| Technological Characteristics (Similarities) | Employ same tongue restraint principles to encourage nasal breathing and oral control/snoring. | Confirmed. |
| Technological Characteristics (Differences) | Improve on prediacte (e.g., totally concealed). | Totally concealed (unlike predicates). |
| Substantial Equivalence | As safe and effective and perform as well as legally marketed oral devices. | Non-clinical tests demonstrate the new device is "as safe and effective and perform as well as the legally marketed oral devices." |
What is missing from the document regarding acceptance criteria and performance:
- Specific, quantifiable metrics for "snore control" (e.g., percentage reduction in AHI, snore events per hour).
- Defined thresholds for "success" or "effectiveness."
- Data on patient comfort, adherence, or other common performance indicators for sleep aids.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly defined as a formal "test set" in the context of a clinical trial. The "trials" mentioned were on the applicant's wife and son (sample size = 2).
- Data Provenance: The document explicitly states, "Clinical tests have not been taken." The data comes from non-clinical observations and personal use by the applicant and two family members. It is retrospective for the applicant's 5+ years of use, and a short-term observation for the wife and son. The country of origin is implicitly the USA as the submission is to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Zero in a formal sense. The evaluation was primarily self-assessment by the inventor (Arthur Perlis) and anecdotal feedback from his wife and son.
- Qualifications of Experts: Not applicable, as no external experts were used for ground truth establishment.
4. Adjudication Method for the Test Set
- Adjudication Method: None. There was no formal adjudication process as there were no multiple readers/experts evaluating the device's performance against a pre-established ground truth. The inventor directly observed and interpreted the results.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical tests have not been taken."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
- This question is not applicable as the device is a physical oral appliance, not an algorithm or AI. Standalone performance typically refers to the performance of an AI model without human intervention.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the device's effectiveness was established through self-observation and qualitative feedback, primarily using a voice-actuated tape recorder to distinguish between oral and nasal snoring and personal assessment of "total" oral snore control. For safety, it was the applicant's 5+ years of personal use without adverse events and the ability to expel the device easily.
8. The Sample Size for the Training Set
- Sample Size for Training Set: The concept of a "training set" is not applicable here as the device's design and development were based on the inventor's personal experience and iterative improvements, not a machine learning model. If interpreted loosely as the developmental user base, it would be the inventor himself (N=1) over 5 years.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set was Established: Again, the concept of a formal "training set" and "ground truth" establishment for it doesn't apply to this type of device development. The inventor's own experiences ("mitigate a dry mouth problem and frequent awakenings") with a "failed nasal operation that aggravated a chronic dry mouth problem" led to the invention. The "ground truth" for the invention's need and initial development was the inventor's personal symptoms and his continuous self-monitoring using a voice-actuated tape recorder to refine the device's function.
§ 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.”