(170 days)
The ASD Oral Appliances are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older.
The American Sleep Dentistry (ASD) Oral Appliances include five device models: the ASD Anterior, ASD Mezzo, ASD Lateral, ASD Elastic, and ASD Lateral Mezzo. All are removable, intraoral devices which reposition the mandible and each is patient specific to individual patient anatomy.
The devices are comprised of thermoformed polymer splints (copolyester or EVA), which are connected via a hook and base mechanism or elastic bands or straps.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria.
The document is a 510(k) Premarket Notification from the FDA regarding the "American Sleep Dentistry (ASD) Oral Appliances". It primarily focuses on demonstrating substantial equivalence to existing predicate devices for the purpose of market clearance.
It describes:
- The device's trade name, regulation number, and product code.
- The device's intended use: "reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older."
- A comparison of the technological characteristics (anatomic location, intended use, basic design, principles of operation, materials, manufacture) of the ASD Oral Appliances to several predicate devices.
- A detailed table comparing features like intended use, prescription/OTC use, principle of operation, design, materials, range and precision of adjustment, target population, where used, energy used/delivered, human factors, and sterility across the ASD devices and the predicate devices.
There is no mention of:
- Specific acceptance criteria (numerical thresholds for performance).
- Any performance studies, clinical trials, or validation test results demonstrating the device meets quantitative performance metrics.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- MRMC studies or effect sizes.
- Standalone algorithm performance.
- Types of ground truth used or how it was established.
The conclusion simply states that the new device has the "same intended use" and "same technological characteristics" as the predicate devices, thus not raising "new questions of safety and effectiveness," and is therefore "substantially equivalent." This is a regulatory determination based on comparison to existing devices, not a performance validation study.
§ 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.”