(63 days)
- An oral appliance to be used for the treatment of mild and moderate Obstructive Sleep Apnea.
- For the treatment of snoring.
- For the prevention of bruxism.
The Full Breath Sleep Appliance PB & PBB is a custom device fabricated typically by a Professional dental laboratory and delivered by a dentist. This is a simple enhancement to the design of the Quiet Night & Quiet Night MA (K032410). It incorporates the Quiet Night function of control of vertical dimension and mandibular advancement for reduction/elimination of snoring. It also incorporates the posterior trans-palatal bar of the Quiet Night and Quiet Night MA to prevent the tongue from sealing against the palate and thus reduce snoring. It also restrains the tongue from up and back movement. The tongue restraint has resulted in reduced AHI/RDI's, and elevation of the O2 low saturation (nadir) when sleeping.
This 510(k) premarket notification for the Full Breath Sleep Appliance (PB and PBB) does not contain a study that establishes acceptance criteria or demonstrates device performance against those criteria. The submission primarily focuses on establishing substantial equivalence to previously cleared predicate devices.
Here's a breakdown of what can be inferred from the provided text regarding a study, and what information is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated or defined in the provided document. The 510(k) relies on substantial equivalence to predicate devices, implying that acceptable performance is generally aligned with those devices.
- Reported Device Performance: The document only makes a qualitative claim: "The tongue restraint has resulted in reduced AHI/RDI's, and elevation of the O2 low saturation (nadir) when sleeping." No quantitative data or metrics are provided to support this claim. Therefore, a table comparing acceptance criteria to reported performance cannot be constructed from this document.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- This information is not provided in the document. The statement "The tongue restraint has resulted in reduced AHI/RDI's, and elevation of the O2 low saturation (nadir) when sleeping" is a general claim without details of a specific study, sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided because no specific study with a "test set" and "ground truth" establishment is detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not provided as no specific study or test set is described.
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
- This is not applicable to the Full Breath Sleep Appliance. This device is a physical intraoral appliance, not an AI or imaging diagnostic tool that would involve "human readers" or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable to the Full Breath Sleep Appliance, for the same reasons as point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- This information is not provided as no specific study with established ground truth is detailed.
8. The sample size for the training set
- This information is not provided. This device is not an AI/machine learning model, and thus does not have a "training set" in that context. If a clinical study was undertaken, it would involve participants to evaluate clinical outcomes, but details of such a study are absent.
9. How the ground truth for the training set was established
- This information is not provided as there is no "training set" in the context of an AI/machine learning model.
Summary of Study Information in the K053065 510(k):
The provided 510(k) summary for the Full Breath Sleep Appliance is focused on demonstrating substantial equivalence to predicate devices (Quiet Night & Quiet Night MA, Breathe EZ Anti-Snoring Device, Sleepbite, The Silencer) that have already been cleared for similar indications. It does not include detailed clinical study data or a statistical analysis of performance against specific acceptance criteria.
The only statement related to performance is: "The tongue restraint has resulted in reduced AHI/RDI's, and elevation of the O2 low saturation (nadir) when sleeping." This is a general claim about the device's effect, but no supporting data (e.g., from a clinical trial, sample size, methodology, statistical significance) are presented in the provided text. For a 510(k) submission, particularly for Class II devices, clinical data demonstrating safety and effectiveness may not always be required if substantial equivalence to a predicate device can be established through technological characteristics and indications for use.
§ 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.”