(78 days)
The MDSA is an intraoral device (mandibular repositioning) for the treatment of snoring and sleep apnea. The device is worn during sleep with the intention to reduce the incidence of snoring and obstructive sleep apnea.
Prescription Device
Custom-Made
Mandibular Repositioning Device
Reduce Snoring
Treat Mild to Moderate Obstructive Sleep Apnea
Single Patient / Multi-Use
Not for Use in Persons Younger than 18 Years of Age
Home or Sleep Laboratory Environment
The MDSA is an intraoral dental device for the treatment of snoring and sleep apnea. The MDSA is worn during sleep with the intention to reduce the incidence of snoring and obstructive sleep apnea.
The MDSA is a prescription Custom Made titratable mandibular repositioning device for the dental treatment of patients suffering snoring and obstructive sleep apnea.
Patient's dental impressions must be used to construct the device. The MDSA is a 2-part device. With an upper containing the hook component in the front that when in the patient's mouth engages a shelf in the lower.
The MDSA is supplied with an Adjuster Key, which is used to move the hook in the upper to advance the lower jaw forward and accordingly advance the mandible and tongue thereby improving patency of the airway, decrease air turbulence and aid improvement of obstructive sleep apnea.
The MDSA can be molded with commonly available materials used by Dental Laboratories either Hard Acrylic and ball clasps or Double Laminate (Hard /Soft) Functional mouthguard materials for the construction of the device.
A Bite Registration taken at the same time as the impressions facilitates the Laboratory technician correctly locating the components during construction.
Because of its unique design when incitu the patient has full lateral movement and the device can be titrated to the individual patients needs.
The advantage of the MDSA is that its construction can be easily performed by a normally qualified Laboratory Technician using standard Laboratory Equipment. This affords a saving in costs to the end user.
The MDSA components are made from Medical Grade 316 Stainless Steel. The Hook/Screw component is welded into its outer housing to ensure security during use.
The provided text is a 510(k) summary for the MDSA (Anti-Snoring / Sleep Apnea Device). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with specific acceptance criteria and performance metrics typically found in a clinical trial report or a more extensive PMA submission.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the way a clinical study report would.
Specifically, the document lacks:
- A table of acceptance criteria and reported device performance: There are no quantitative performance metrics (e.g., reduction in AHI, snore reduction percentages, or specific comfort scores) and no pre-defined acceptance criteria for these metrics.
- Sample size used for the test set and data provenance: No test set is mentioned, nor any details about its size, country of origin, or retrospective/prospective nature.
- Number of experts and their qualifications for ground truth: No experts are mentioned in the context of establishing ground truth for a test set.
- Adjudication method: Not applicable as no ground truth is being established by experts.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned. The device is a physical intraoral device, not an AI-assisted diagnostic tool for human readers.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device.
- Type of ground truth used: Not discussed, as no specific performance outcomes are being evaluated against a ground truth in this document.
- Sample size for the training set: Not applicable as this is a physical medical device, not a machine learning model.
- How ground truth for the training set was established: Not applicable.
What the document does provide is:
- Device Description: An intraoral dental device for the treatment of snoring and sleep apnea, worn during sleep, custom-made, titratable mandibular repositioning device.
- Intended Use: To reduce the incidence of snoring and obstructive sleep apnea.
- Technological Characteristics Summary: Compares the MDSA to a predicate device (TAP, K962516), highlighting similarities (indications for use, single patient, multi-use, prescription, non-sterile, custom fabricated, adjustable, environment, components, materials, removable) and minor differences (adjuster key vs. winder, hook/shelf mechanism vs. lingual bar).
- Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices, which means it is as safe and effective as a legally marketed device. This determination is based on the comparison of technological characteristics as outlined.
In conclusion, this 510(k) summary is a regulatory document to establish "substantial equivalence" of a new device to an existing one, not a clinical study report detailing performance against specific acceptance criteria.
§ 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.”