(221 days)
The ATG/SM-OSA appliances are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The ATG/SM-OSA appliances are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.
The ATG/SM-OSA APPLIANCES are primarily polymer trays that are used intraorally over the dentition to make the mandible protrude. Three designs are included: Adjustable Herbst, Adjustable Dorsal, and MIRS. The mandible protrusion is controlled by stainless steel tubes & rods or screws for the Herbst and Dorsal designs. The MIRS single-piece construction has a lingual rest to set the mandibular protrusion. Each device is fabricated to the prescription of a dentist.
The provided text describes a 510(k) premarket notification for the ATG/SM-OSA APPLIANCES. This submission is for a medical device that does not require a clinical study with acceptance criteria and performance data in the typical sense of an AI/ML device.
The basis for this 510(k) submission is substantial equivalence to a predicate device, meaning the new device (ATG/SM-OSA APPLIANCES) is essentially identical in intended use, design, function, and materials to an already legally marketed device (DynaFlex® Anti-snoring and Sleep Apnea Devices).
Therefore, many of the requested elements for an AI/ML device study (like sample size, ground truth, expert consensus, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.
Here's a breakdown of the relevant information provided and why other sections are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Demonstrated by substantial equivalence to predicate device. The new devices are believed to be as safe, as effective, and perform as well as the legally marketed predicate devices. |
| Intended Use | Identical to predicate device: Reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults by supporting the lower jaw in a forward position. |
| Designs | Essentially identical to predicate device, with minor variations in materials (e.g., metallic palate for adjustable Herbst design) that do not change function or affect safety/efficacy. |
| Functions | Identical to predicate device: Mandibular advancement. |
| Materials | Primarily dental polymers (dental acrylic and dual-laminate polymers) and stainless steel, identical to predicate devices. New metallic palate material for one design is a dental alloy used for partial dentures and does not introduce new risks. |
| Risks | No new risks introduced compared to predicate devices. Management of risks (TMJ soreness, soft tissue soreness, dentition complications) is achieved through advising patient and dentist in directions for use, emphasizing early and repeated examination and proper adjustment. |
Study Proving Acceptance Criteria:
No formal clinical study with acceptance criteria and a specific performance measurement was conducted or described in this document for the ATG/SM-OSA APPLIANCES. Instead, the "study" proving the device meets the acceptance criteria is a comparison and analysis of the new device against its predicate device to demonstrate substantial equivalence.
The manufacturer, Selane Products Inc., performed:
- An FMEA (Failure Mode and Effects Analysis) risk analysis.
- Evaluation of the materials of construction.
- Evaluation of the design.
2. Sample size used for the test set and the data provenance
- Not Applicable. No test set, clinical data, or performance data from human subjects was used for this 510(k) submission. The submission relies on demonstrating similarity to a previously cleared predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No ground truth for a test set was established as no clinical study or test set was mentioned.
4. Adjudication method for the test set
- Not Applicable. No test set was used.
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
- Not Applicable. This is a physical medical device, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device.
7. The type of ground truth used
- Not Applicable. No ground truth was established for a performance study. The "ground truth" for this submission is the established safety and effectiveness of the predicate device.
8. The sample size for the training set
- Not Applicable. No training set was used. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. No training set was used.
§ 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.”