(271 days)
This appliance is designed to treat primary snoring and mild to moderate obstructive sleep apnea in adults.
The Luco Hybrid OSA Appliance is a two part (upper and lower) mandibular advancement appliance that advances the mandible (and tongue) into a forward position and maintains it there while sleeping. This appliance, as well as all three predicates identified, are made patient specific by a dental lab for each patient. The framework of the Luco Hybrid OSA appliance is constructed of dental alloy (chrome cobalt), similar to a cast partial denture, increasing its strength. The acrylic used for the pads, wings and adjustment blocks is orthodontic methyl methacrylate from Dentaurum. All of the predicate appliances use orthodontic methyl methacrylate from Dentaurum in their design. Orthodontic type ball clasps are placed on the inside (lingual surfaces) of the bicuspids and molars for retention. The SomnoMed MAS and Oravan OSA also use orthodontic ball clasps and wires for retention. There are acrylic pads on both the upper and lower appliances which cover and protect the posterior teeth (similar to all the predicates). There is no acrylic over the upper and lower incisors; instead there is an orthodontic type retainer wire to prevent flaring of the upper and lower incisors and a cast dental alloy custom fit plate behind the lower incisors. The predicate Oravan OSA appliance similarly does not place acrylic in the anterior of upper and lower teeth. The absence of any acrylic over the incisors in the front of the mouth allows freedom to breathe through the mouth as needed or to evacuate the oropharynx in the case of illness or an emergency such as vomiting. The patient can speak and drink water without removing the appliance. The absence of any material in the anterior region also activates and inhibits pharyngeal reflexes which result in the tongue posturing forward. The Luco Hybrid and all three predicates use wings on the lower appliance that extend upward contacting adjustable blocks on the upper appliance. These wings retain the lower jaw in a predetermined position while allowing the patient to open and move laterally with freedom. The adjustment blocks of the upper appliance have adjustment screws that permit fine adjustments (each turn gives ¼ mm advancement, up to 6mm) similar to all of the predicates. The predetermined position is determined by the dentist ordering the appliance; usually as a bite registration taken with a dedicated apparatus such as a George Gauge® (these are readily available from dental supply companies) similar to the predicate appliances. Advancing the mandible prevents blockage of the upper airway permitting normal air exchange, and effectively treating primary snoring and mild to moderate obstructive sleep apnea. The pads are constructed such that the main area of contact is in the forward 25% of the pads with no contact in the molar regions. The pads (both on the upper and lower appliance) have a chrome cobalt mesh inside for increased strength. The wings of the lower appliance as well as the upper adjustment blocks also have chrome cobalt mesh for strength. This mesh is continuous with the main framework of the appliance providing considerable strength.
The provided document is a 510(k) summary for the Luco Hybrid OSA Appliance. It aims to demonstrate substantial equivalence to previously cleared predicate devices rather than providing a detailed performance study with acceptance criteria in the manner typically seen for novel diagnostic or treatment devices. Therefore, the information provided focuses on comparability and known clinical use, not a formal prospective study with predefined acceptance criteria and statistical analysis of performance metrics.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define quantitative acceptance criteria for device performance. Instead, it relies on demonstrating equivalence to predicate devices and reports on successful clinical use. The "Performance" row in Table 1 (Page 2) serves as the closest equivalent to reported device performance, stating:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Indications for Use: Treat primary snoring and mild to moderate obstructive sleep apnea in adults (same as predicates). | "This appliance is designed to treat primary snoring and mild to moderate obstructive sleep apnea in adults." (Page 2) |
| "Has been successfully used to treat all the conditions listed in the indications for use" (Page 2) | |
| Target Population: Adults (same as predicates). | "Adults" (Page 2) |
| Anatomical Sites: Mandibular advancement appliance, worn on upper and lower teeth (same as predicates). | "Mandibular advancement appliance, worn on upper and lower teeth" (Page 2) |
| Material Biocompatibility: Uses FDA-approved and Class I materials and does not use dyes (superior to some predicates which use pink dye). | "Uses all FDA approved materials and Class I materials that are used commonly in dentistry. Does not use any dyes." (Page 2) |
| Mechanical Strength/Durability: Durable and resistant to fracture, long-lasting framework. | "By combining these recognized materials into one appliance, the Luco Hybrid has proven to be durable and highly resistant to fracture. Some of the original appliances are seven years of age or more without damage." (Page 3) |
| "The cast framework of the Luco Hybrid can last decades if cared for." (Page 3) | |
| Efficacy of treatment for OSA/Snoring: Successfully treats mild to moderate obstructive sleep apnea and primary snoring. | "The Luco Hybrid OSA Appliance has been successfully used on over 125 patients... All were diagnosed and re-tested with their appliance in the same sleep lab using the same parameters. All patients all were successfully treated except one..." (Page 3) |
| "Before and after sleep studies have verified the efficacy of this appliance." (Page 3) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions that "The enclosed data (30 patients) was collected on patients diagnosed with mild to moderate obstructive sleep apnea and primary snoring over a five year period." This 30-patient dataset appears to be the primary "test set" for demonstrating clinical efficacy.
- Data Provenance: The study was conducted on "Canadian Military personnel" (Page 3). The sleep studies were conducted in "the same sleep clinic" (Page 3) and involved "overnight sleep studies." This indicates a prospective or retrospective clinical observation (uncontrolled) approach where patients were diagnosed and re-tested over time with the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated. The document mentions patients were "diagnosed using 16 channel polysomnogram recordings in sleep clinics, in overnight sleep studies, monitored by a sleep specialist." (Page 3). It implies a single "sleep specialist" per patient encounter, but doesn't specify if a panel of experts established an adjudicated ground truth retrospectively for the study.
- Qualifications of Experts: "Sleep specialist" (Page 3) is mentioned. No further details on their specific qualifications (e.g., years of experience, board certification) are provided.
4. Adjudication Method for the Test Set
Not applicable. The description refers to individual patient diagnosis and re-testing overseen by a "sleep specialist" (Page 3). There is no mention of a multi-reader adjudication process for the "test set" data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not stated to have been done. The study focuses on the device's performance in patients, 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
Yes, in a way. The "performance" described is the direct effect of the physical appliance on patients as measured by polysomnograms, which can be considered a "standalone" effect of the device itself (not an AI algorithm). The device is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
The ground truth for the clinical efficacy was established through polysomnogram recordings (16-channel) and diagnosis by a "sleep specialist" in a sleep clinic setting. This is considered objective physiological data combined with expert interpretation. Efficacy was verified by "Before and after sleep studies" (Page 3).
8. The Sample Size for the Training Set
Not applicable. This is a 510(k) submission for a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device's design and materials are based on "extensive history of use in dentistry" and "recognized materials" (Page 3).
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set mentioned in the context of an AI/ML algorithm. The "training" for this device comes from the established clinical history and performance of similar materials and designs in dentistry and in the predicate devices.
§ 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.”