(166 days)
The Nu Sleep appliance is indicated to treat mild to moderate Obstructive Sleep Apnea.
Nu Sleep appliance is a patient specific made device for each patient which consists of two dental plates, upper and lower, made of Acrylic.
The attachment is at a 40 degree angle to enable movement of the appliances, thus patient can open and close while wearing the appliances. The appliance is open in the front and allowing the patient to inhale and exhale more air per breath.
The RH Associates obstructive sleep apnea appliance "Nu-Sleep" is offered in Hard/Soft which has a dual laminate layer that provides a soft layer on the tooth surface which is made of acrylic.
Here's a breakdown of the acceptance criteria and the study details for the Nu Sleep device, based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating similarity or equivalence to predicate devices in terms of reducing snoring and apneic events. The reported device performance is presented as "success rate of reduction of snoring and the success rate of reduction of apneic events measured by polysomnograms." No specific percentage or numerical target for success is provided, nor is the "success rate" itself quantified in the document.
Therefore, the table below reflects what can be inferred from the provided text.
| Acceptance Criteria (Inferred from equivalence claim) | Reported Device Performance (as stated) |
|---|---|
| Reduction of snoring similar to predicate devices | Demonstrated "success rate of reduction of snoring" |
| Reduction of apneic events similar to predicate devices | Demonstrated "success rate of reduction of apneic events" |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: 31 patients.
- Data Provenance: The study was conducted at "one facility." The country of origin is not explicitly stated. It was a prospective study, as observations were made in two stages (without and with the appliance).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The study mentions "Objective criteria have been observed and have been measured," referring to RDI, AHI, and ODI, typically captured via polysomnography, which is interpreted by trained professionals. However, the number and qualifications of individuals interpreting these results or establishing the "ground truth" for the study's claims are not detailed.
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Adjudication method for the test set:
- This information is not provided in the document.
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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 performed or mentioned. This device is an intraoral appliance, not an AI or imaging diagnostic tool that would typically involve human reader evaluation of AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a medical device (intraoral appliance) and not an algorithm or AI system. Its performance is demonstrated with a human-in-the-loop (the patient wearing the device).
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The type of ground truth used:
- For the clinical evaluation, the ground truth was established by objective polysomnographic measurements: RDI (Respiratory Disturbance Index), AHI (Apnea-Hypopnea Index), and ODI (Oxygen Desaturation Index).
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The sample size for the training set:
- This is not an AI/machine learning device, so there is no concept of a "training set" in the context of this submission. The "training" here refers to the development process of the physical device itself, not an algorithm.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set in the context of an algorithm. For the device development, the "ground truth" would be engineering specifications, material properties, and prior knowledge from predicate devices used in its design.
§ 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.”