(151 days)
The Healthy Sleep Appliance is intended for use in patients 18 years of age or older for the reduction of snoring and mild to moderate obstructive sleep apnea.
The Healthy Sleep Appliance is a mandibular repositioning oral appliance used to treat snoring and mild to moderate obstructive sleep apnea. It is composed of an upper and a lower tray made to fit the occlusal surface of the teeth. These full arch trays are connected to each other by stainless steel arms that are set to conform to the predetermined occlusal relationship of the upper and lower arches. These arms have an adjusted length that can be adjusted as needed to exert a forward force on the lower jaw and advance the mandible relative to the maxilla. The advancement of the lower jaw increases the patient's pharyngeal space which facilitates improved air exchange.
This looks like a medical device submission, specifically a 510(k) summary for the "Healthy Sleep Appliance." The document describes the device, its indications for use, and a comparison to a predicate device. It also includes a "Clinical Testing Summary" which details a small study.
Here's an analysis of the provided information to answer your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for the device's performance in a quantitative way (e.g., "The device must reduce AHI by X% in Y% of patients"). Instead, the study aims to demonstrate substantial equivalence by showing similar outcomes to existing oral appliance therapy and the predicate device.
The reported device performance from the 7-patient study is as follows:
| Subject | Gender / Age | Pre AHI | Post AHI | Reduction in AHI |
|---|---|---|---|---|
| One (1) | Female / 39 | 101.1 | 2.1 | 99.9% |
| Two (2) | Male / 58 | 46.3 | 5.2 | 88.8% |
| Three (3) | Female / 55 | 9.9 | 4.0 | 59.5% |
| Four (4) | Male / 45 | 34 | 1.5 | 95.6% |
| Five (5) | Female / 31 | 30.5 | 0.5 | 98.4% |
| Six (6) | Male / 54 | 9 | 1.8 | 80.0% |
| Seven (7) | Female / 45 | 6.2 | 0 | 100.0% |
Note: The document explicitly states: "Note Subjects # 1, 2, 4, and 5 were diagnosed with severe OSA and Oral Appliance therapy . was not recommended for them." This suggests that while their AHI improved significantly, these specific cases might fall outside the device's intended population for recommendation, which is for mild to moderate obstructive sleep apnea. However, the data is presented, showing the device's effect across these patients.
The overall conclusion is that the device "was well tolerated and effective with individuals with mild to moderate OSA that had not tolerated CPAP."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 7 patients.
- Data Provenance: The document does not specify the country of origin. It appears to be a prospective study, as it describes a "seven patient clinical study was conducted comparing the Healthy Sleep Appliance vs. the predicate Herbst Splint (K083209)." This implies the study was specifically undertaken to gather data for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study involved polysomnography (PSG) for pre- and post-treatment evaluation, which is the standard diagnostic test for OSA. However, the document doesn't detail who interpreted these PSGs or their qualifications.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not an AI device. Therefore, an MRMC study with AI assistance is not applicable and was not performed. The study is a direct comparison of the device (Healthy Sleep Appliance) against a predicate device (Herbst Splint) in terms of patient outcomes (AHI reduction).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not an AI device. Therefore, a standalone algorithm performance study is not applicable and was not performed. The device is a physical oral appliance.
7. The Type of Ground Truth Used
The ground truth for the effectiveness of the device in reducing sleep apnea was established through polysomnography (PSG), which is considered the gold standard for diagnosing and assessing the severity of sleep apnea. The specific metric used was the Apnea/Hypopnea Index (AHI).
8. The Sample Size for the Training Set
There is no training set in the context of an algorithm. This is a physical medical device. The "training" for establishing its effectiveness comes from the clinical study on the 7 patients and a review of existing literature (Ferguson, et.al., Oral Appliances for Snoring and Obstructive Sleep Apnea: A Review).
9. How the Ground Truth for the Training Set Was Established
As this is not an AI device, the concept of a "training set" and its ground truth establishment does not apply in the conventional sense. The "ground truth" for the device's performance evaluation was established by measuring AHI through polysomnography in the 7 human subjects before and after using the device.
§ 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.”