(87 days)
Temporary treatment of obstructive sleep apnea and snoring to determine in which patients mandibular advancement and opening the bite will increase the patients air space
The EMA-T appliance is a modified functional orthodontic appliance. The modifications are: 1) clasps are not needed as the appliance is retained firmly to the teeth by dental impression material into undercut areas. Each tray holds the teeth in their present location not allowing tooth movement. 2) the bite is opened with bite planes as in the Elastic Mandibular Advancement appliance. 3) the mandible is advanced with an elastic strap similar to the Elastic Mandibular Advancement appliance.
The appliance is designed for universal application in adults with the use of one-sizefits all maxillary and mandibular hard plastic trays. On the night of the titration polysomnogram, the sleep technician makes impressions of the maxillary and mandibular teeth by placing a fast setting dental silicone putty material (such as E and D Dental Products Incorporated) in the tray and pushing the tray onto the patient's teeth. The trays and putty with the patient's impression are removed from the mouth. Just before the start of the sleep study, the impression and the patient's teeth are dried off. A liguid silicone "wash" is placed onto the patient's impression and placed on the maxillary and mandibular teeth and arches for the duration of the study. This "wash" holds the trays firmly on the patient's teeth and prevents their dislodgment during sleep. On the anterior of the maxillary tray is a rod that protrudes at the midline in front of the patient's central incisors. A Styrene Block Copolymer strap with a pull tab and holes 3 millimeters apart is connected to the mandibular tray. Mandibular advancement is achieved by pulling the tab forward and inserting the rod into one of the holes on the pull tab. The mandible is thereby held in an advanced position by the stationary maxilla, and is advanced in 3 millimeter increments. As the sleep lab technician advances the mandible, the polysomnogram will show a decrease, or even an elimination, of the patient's apneas on those responding. A prescription will then be given to the patient for a permanent custom made oral appliance.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Elastic Mandibular Advancement Titration (EMA-T) appliance:
K973884 - Elastic Mandibular Advancement Titration (EMA-T) Appliance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Effectively determine which obstructive sleep apnea (OSA) and snoring patients will respond favorably to mandibular advancement and bite opening. | "The EMA-T device effectively determined which obstructive sleep apnea and snoring patients will respond favorably to mandibular advancement and bite opening." |
| (Implicit) Patients identified as responders by EMA-T titration who receive a permanent custom appliance should respond favorably. | "To this date 100% of the patients obtaining a permanent custom appliance have responded favorably." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 12 obstructive sleep apnea (OSA) patients.
- Data Provenance: Prospective. The study involved performing "overnight sleep studies with the EMA-T device" on these patients. The study was conducted at The University of Texas Medical Branch at Galveston, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not explicitly state the number of experts or their specific qualifications (e.g., years of experience as a radiologist) used to establish the ground truth. It implies that the "sleep lab technician" observes the polysomnogram (PSG) during the titration, and that a "prescription will then be given to the patient for a permanent custom made oral appliance" if they respond. This suggests clinical judgment based on PSG readings. The final determination of "favorable response" for the 5 patients who received permanent appliances would have been made by a physician, presumably a specialist in sleep medicine.
4. Adjudication Method for the Test Set:
The document does not mention a specific adjudication method like 2+1 or 3+1. The assessment appears to be based on the real-time observation of "decrease, or even an elimination, of the patient's apneas" during the polysomnogram as the mandible is advanced. For the 5 patients who received permanent appliances, the "favorable response" likely refers to post-implantation clinical outcomes, which would have been assessed individually by the treating physicians, rather than a structured adjudication panel.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. The study focuses on the performance of the device in identifying responders, not on comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
No, a standalone evaluation of an algorithm was not performed. The EMA-T appliance is a physical medical device, not an AI or algorithm-based diagnostic tool. The device itself is used by human technicians to titrate and observe patient response.
7. The Type of Ground Truth Used:
The ground truth for determining a favorable response appears to be a combination of:
- Physiological Response Data: Reduction or elimination of apneas observed on a polysomnogram (PSG) during titration with the EMA-T.
- Clinical Outcomes Data: For the 5 patients who received a permanent custom oral appliance, their "favorable response" implies positive clinical outcomes after receiving the permanent treatment, leveraging the information gained from the EMA-T titration.
8. The Sample Size for the Training Set:
This device is a physical medical appliance, not an AI or machine learning model. Therefore, there is no training set in the context of AI. The "clinical testing" mentioned served as the validation study for the device's intended use.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for an AI/ML model, this question is not applicable. The device's efficacy was demonstrated through the clinical study on 12 patients, where the ground truth was established by real-time PSG observations and subsequent clinical outcomes for those who received permanent appliances.
§ 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.”