(90 days)
The Serena Sleep Appliance is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
The Serena Sleep Block Mandibular Advancement is an intraoral device that treats snoring and sleep apnea through mandibular repositioning the lower jaw forward from its normal location, the patient's pharyngeal space is increased and their ability to exchange air during sleep is improved. This device consists of custom fitted trays which fit over the upper and lower teeth. Based on the physician's prescription, positioning blocks are built into the upper and lower trays The mandibular advancement is achieved through the physician's selection of a specific upper and lower tray that when fitted, sets the optimal mandibular advancement. The separate two-piece construction is desirable for patients that want greater range of motion and lateral movement.
The Elastic Mandibular Advancement model is similar to the Block Mandibular Advancement but has exterior pins that allow for the use of rubber bands rather than the blocks. These bands provide additional treatment options and forces for repositioning the bottom jaw.
The provided text describes the 510(k) premarket notification for the Serena Sleep Block Mandibular Advancement (BMA) and Elastic Mandibular Advancement (EMA) devices. The core of the submission is to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving a specific performance metric against acceptance criteria in the traditional sense of a new technology.
Therefore, the "acceptance criteria" here are based on the comparison to the predicate devices, showing that the Serena Sleep devices are as safe and effective as the existing ones. The "study" proving this largely involves bench testing and a detailed comparison of features.
Here's an analysis of the "acceptance criteria" and the "study" based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly met by demonstrating "equivalence" to the predicate devices across various specifications. The "reported device performance" is mainly shown through bench testing results.
| Acceptance Criteria (Implicit for Equivalence) | Subject Device Performance (Serena Sleep) | Predicate Device Performance (Prosomnus MicrO2 for BMA, O2Vent Optima for EMA) | Comparison Result |
|---|---|---|---|
| Indications for Use | Reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults. | Identical (BMA), Similar (EMA - includes "during sleep to aid in the treatment") | Equivalent |
| Product Code | LRK | LRK | Equivalent |
| Regulations | 21 CFR 872.5570 | 21 CFR 872.5570 | Equivalent |
| Device Class | Class II | Class II | Equivalent |
| Use of Device | Removable intraoral, single patient multiple use, prescription use only. | Removable intraoral, single patient multiple use, prescription use only. | Equivalent |
| Target Population | Adults (over 18) for snoring and mild to moderate OSA. | Adults (over 18) for snoring and mild to moderate OSA. | Equivalent |
| Device Functionality | Repositions lower jaw forward, increases pharyngeal space to improve air exchange. | Identical | Equivalent |
| Teeth Retention Method | Rigid trays (PA 2200) | Rigid trays (PMMA for MicrO2, PA 2200 for Optima) | Similar (BMA - different material), Equivalent (EMA) |
| Tray Separation | Upper and lower trays are separate. | Upper and lower trays are separate. | Equivalent |
| Mandibular Advancement Mechanism | BMA: Positioning blocks built into trays. EMA: Exterior pins allowing rubber bands. | MicrO2: Twin-mated positioning posts. Optima: Protrusions/lugs with connector. | Similar (BMA), Equivalent (EMA) |
| Mandible Adjustment | Clinician adjustable (BMA); Clinician and patient adjustable (EMA). | Identical | Equivalent |
| Design | Designed from digital scans, 3D printed Nylon 12 (PA 2200). | CAD/CAM generated, PMMA (MicrO2); CAD/CAM, additive manufacturing, Nylon 12 (PA 2200) (Optima). | Similar (BMA-different material), Equivalent (EMA) |
| Supplied State | Non-sterile | Non-sterile | Equivalent |
| Materials (Trays) | Nylon 12 (PA 2200) | Hard PMMA (MicrO2); Nylon 12 (PA 2200) (Optima) | Similar (BMA - different material), Equivalent (EMA) |
| Materials (Straps/Connectors for EMA) | 100% thermoplastic Polyurethane/cured elastomer | 100% thermoplastic Polyurethane/cured elastomer | Equivalent |
| Cleaning Instructions | Water with soft toothbrush, rinse, dry, store in case. | Similar (BMA - "Cleaned daily"); Identical (EMA). | Similar/Equivalent |
| Biocompatibility (ISO 10993-5) | Passed | Passed (Optima); Not performed for MicrO2 as materials were identical to prior cleared device. | Equivalent |
| Mechanical Performance (Compression, Shear, Bruxism, Durability) | Withstood forces greater than expected jaw forces during nighttime clenching/bruxing for one year of use. | Not explicitly detailed for predicates, but implicit acceptance is that Serena devices meet similar safety/performance. | Met / Comparable |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not mention a "test set" in the context of human subjects or a clinical study. It refers to "Performance Testing (Bench)" which would involve physical device samples.
- Sample Size for Bench Testing: Not explicitly stated how many devices were tested for compression, shear, bruxism, and durability.
- Data Provenance: The bench testing was conducted internally by the manufacturer (Serena Sleep). The document doesn't specify the country of origin of this testing data. The data is retrospective in the sense that it's reported after the testing completion.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as there was no clinical test set involving human subjects requiring expert ground truth establishment. The ground truth for device performance was established through engineering and mechanical testing methodologies against known maximum jaw forces from literature.
4. Adjudication Method for the Test Set
Not applicable, as no human-in-the-loop clinical test set was conducted that would require adjudication.
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 device is a physical intraoral appliance, not an AI-powered diagnostic tool, and no MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device. The core "performance" was physical bench testing of the device for mechanical integrity and durability.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the bench testing, the "ground truth" for mechanical forces was established through:
- Literature search of maximum jaw strengths: This implies reliance on established scientific or engineering data regarding biomechanical forces in the human jaw.
For the comparison for substantial equivalence, the "ground truth" was the specifications and performance of the legally marketed predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there was no training set.
§ 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.”