(236 days)
Silent Nite® sl is indicated to reduce snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older. Silent Nite® sl is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.
Silent Nite® sl is a mandibular advancement device (MAD) intended to treat snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older who prefer it to CPAP or surgical treatment, or who do not respond to, are not appropriate candidates for, or who fail treatment attempts with CPAP or surgical treatment. Silent Nite® sl holds the mandible in a protrusive position to increase the volume of the nasopharynx and the oropharynx and improves airflow during sleep. It is meant to be worn during sleep by a single patient. It consists of one upper tray, one lower tray, and two connectors and is provided non-sterile. The trays are patient-specific and conform precisely to the patient's dentition. A biocompatible dual-layered heat sensitive impression material make up the upper and lower trays. The trays consist of a soft polyurethane inner layer that provides patient comfort and a durable hard polyester outer layer. A completely rigid polyester material is necessary for the fabrication of the lower tray when the patient has poor retention. The maxillary tray is connected to a mandibular tray by two connectors of the same length. Each connector is fixed to the anterior of the maxillary tray and the posterior of the mandibular tray, on the respective right and left buccal sides. The amount of mandibular protrusion is adjusted by varying the length of the connectors. The shorter the connector the more anteriorization. Silent Nite® sl connectors are available in six different lengths (21.0 mm, 22.0 mm, 24.0 mm, 24.0 mm, 25.0 mm, and 26.0 mm) to allow the device to be adjusted up to 6.0 mm, in 1.0 mm increments.
The provided text is a 510(k) summary for the Silent Nite® sl device. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence. However, this document does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria through clinical data or AI model performance metrics.
The "Performance Data" section explicitly states: "Prismatik Dentalcraft, Inc. relies on the existing predicated devices for the safety and effectiveness of the Silent Nite® sl for its intended use. Non-clinical (bench performance testing) data was used to support the substantial equivalency."
The listed tests (ASTM D570, ASTM D790, ISO 20795-1, ASTM D638, ASTM D412, ISO 179) are all bench (material and mechanical) tests, not clinical studies involving human subjects or AI model performance evaluation.
Therefore, I cannot fulfill the request for information regarding:
- A table of acceptance criteria and reported device performance (for clinical/AI performance)
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method for the test set
- MRMC comparative effectiveness study results or effect size
- Standalone (algorithm-only) performance
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set
- How ground truth for the training set was established
This 510(k) relies on the substantial equivalence principle based on design, materials, manufacturing process, and bench testing, rather than a new clinical study to establish efficacy or an AI model's performance.
§ 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.”