(137 days)
Treatment of nasal respiratory dysfunction of obstructive sleep apnea and snoring in those patients where repositioning of the mandible can increase the patients air space.
The Elastic Mandibular Advancement 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 pressure formed plastic into the undercut areas. Each tray holds the teeth in their present location not allowing tooth movement. 2) the bite is opened as in the SNOAR and NAPA appliances but not in one fixed position. Multiple bite openings are possible because of removable bite blocks or bite planes of varying thicknesses. 3) the mandible is advanced as in both the SNOAR and NAPA appliances except not in a fixed position , but in various amounts of forward advancement because of removable, replaceable elastic bands or straps to pull the mandible forward.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Elastic Mandibular Advancement (EMA) appliance:
It's important to note that this 510(k) summary is from 1997. Regulatory requirements and the detail expected in clinical studies for medical devices have evolved significantly since then. The information provided is considerably less detailed than what would typically be required for a similar submission today.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria (e.g., "the device must reduce AHI by X%"). Instead, it presents the observed clinical outcome from a single study as evidence of effectiveness.
| Acceptance Criteria (Implicit from study findings) | Reported Device Performance |
|---|---|
| Reduction in apnea-hypopnea index (AHI) for OSA patients | Mean AHI reduced from 60 events/hr (without appliance) to 21 events/hr (with EMA appliance) in patients with obstructive sleep apnea. This represents a 65% reduction in AHI. |
| Treatment of nasal respiratory dysfunction of obstructive sleep apnea and snoring by increasing patient's air space | The study concludes: "Use of the EMA device significantly reduced episodes of obstructive sleep apnea." (No specific quantitative data for snoring or increased air space is provided, only AHI). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): 13 obstructive sleep apnea (OSA) patients.
- Data Provenance:
- Country of Origin: United States (Clinical testing was done at The University of Texas Medical Branch at Galveston).
- Retrospective or Prospective: The description "Overnight sleep studies with and without the EMA device were performed on 13 obstructive sleep apnea (OSA) patients" suggests a prospective study design, likely a pre-post comparison within the same patients. However, the study design details are very minimal.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts or their qualifications used to establish the ground truth (diagnosis of OSA and AHI calculation). Given that it involved "Overnight sleep studies," it's highly probable that a sleep physician or a sleep technician interpreted the polysomnography (PSG) data. However, this is an inference, not explicitly stated.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. It simply states that sleep studies were performed and AHI was measured.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses solely on the device's impact on physiological parameters (AHI) in patients, without involving human readers assessing diagnostic performance or the effect of AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This device is not an AI algorithm but a physical medical appliance. Therefore, the concept of a "standalone (algorithm only)" study is not applicable. The study performed assessed the direct physiological effect of the physical device on patients.
7. Type of Ground Truth Used
The ground truth used was physiological outcome data (Apnea-Hypopnea Index - AHI) derived from overnight sleep studies (polysomnography). This is an objective measurement of sleep-disordered breathing severity.
8. Sample Size for the Training Set
The document does not mention a training set. Since the device is a physical appliance and not an AI algorithm, the concept of a "training set" in the context of machine learning is not applicable here. The clinical study described is a performance evaluation of the final device.
9. How Ground Truth for the Training Set Was Established
As there was no training set for an AI algorithm (see point 8), this question is not applicable.
§ 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.”