(294 days)
The SML OSA2 Appliances are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. The SML-OSA2 appliances are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.
The SML-OSA2 APPLIANCES include five device models: Adjustable Sleep Appliance (ASA), Clear Sleep Adjustable Dorsal, Clear Sleep Adjustable Anterior, Quiet Night Appliance (QNA) and V-force.
The SML-OSA2 Appliances are customized, intraoral dental devices designed to reduce snoring and mild to moderate obstructive sleep apnea in adults. The devices fit over the dentition and reposition the mandible in a slightly protrusive position. The SML-OSA2 APPLIANCES consist of 2 arch forms that are linked to advance the mandible, and are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The customized appliance is inserted and removed by the patient and adjusted by the prescribing dentist.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the SML-OSA2 Appliances device:
This document is a 510(k) Premarket Notification for the SML-OSA2 Appliances. In the context of 510(k) submissions, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through de novo performance studies. Therefore, the information provided focuses on comparability and known safety/effectiveness of materials and design.
Acceptance Criteria and Reported Device Performance
The document doesn't present a table of numerical acceptance criteria and a corresponding table of the device's measured performance in the typical sense of a diagnostic or therapeutic device undergoing a detailed performance study. Instead, substantial equivalence to a predicate device (ATG/SM-OSA Appliances, K130130) is the overarching "acceptance criterion" being met.
Here's how the "acceptance criteria" (implicitly, the characteristics of the predicate) and "reported device performance" (characteristics of the subject device) are presented:
| Acceptance Criteria (Predicate Device K130130) | Reported Device Performance (Subject Device SML-OSA2) |
|---|---|
| K-Number: K130130 | K-Number: K162816 |
| Class: II | Class: II |
| Product Code: LQZ, LRK | Product Code: LQZ, LRK |
| Regulation Number: 872.5570 | Regulation Number: 872.5570 |
| Regulation Name: Intraoral Devices for Snoring and Obstructive Sleep Apnea | Regulation Name: Intraoral Devices for Snoring and Obstructive Sleep Apnea |
| Indications for Use: Intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. Worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. Customized, inserted/removed by patient, adjusted by dentist. | Indications for Use: Identical to predicate: Intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. Worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. Customized, inserted/removed by patient, adjusted by dentist. (Stated as identical) |
| Models: Dorsal, Herbst | Models: Adjustable Sleep Appliance (ASA), Clear Sleep Adjustable Dorsal, Clear Sleep Adjustable Anterior, Quiet Night Appliance (QNA), V-force (variations of Dorsal and Herbst designs) |
| Patient Contact Materials: Acrylic, polymers, and stainless steel | Patient Contact Materials: Acrylic, polymers, elastomers, and stainless steel (Elastomers are a new addition, but justified by prior use/FDA Compendium) |
| Biocompatibility: External communicating (>30 days), Surface-contacting (mucosa) per ISO 7405 & 10993-1 | Biocompatibility: External communicating (>30 days), Surface-contacting (mucosa) (No new tests, justified by predicate and proven use of new materials) |
| Sterility: Non-sterile | Sterility: Non-sterile |
| Type of Device: Customized, prescription | Type of Device: Customized, prescription |
| Scientific Principle: Moves lower mandible forward during sleep | Scientific Principle: Moves lower mandible forward during sleep (Stated as identical) |
| Design: Upper and lower arches to support jaw | Design: Upper and lower arches to support jaw (Stated as identical principle) |
| Adjustable or Fixed: Adjustable | Adjustable or Fixed: Adjustable (Stated as identical) |
| Connection Parts: Stainless steel connectors | Connection Parts: Polyoxymethylene (POM) connectors, acrylic spacers, and orthodontic elastomers (Variations justified by prior use/FDA Compendium) |
| Performance Standards: ISO 7405, FDA Class II Special Controls Guidance Document | Performance Standards: Compliance addressed by substantial equivalence and material justification. |
Study Information & Data Provenance
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Sample size used for the test set and the data provenance:
- No specific test set or associated sample size is mentioned. This is a 510(k) submission primarily relying on substantial equivalence to a predicate device, not de novo performance testing.
- The document implies that the "data provenance" for the predicate device's effectiveness would be from its own clearance, but no specific study details are given here for either device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no specific test set or ground truth established for the SML-OSA2 Appliances regarding clinical performance, as no clinical testing was required or performed for this 510(k). The ground truth for the predicate's effectiveness would have been established during its own clearance.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as no specific test set or clinical study requiring adjudication was performed for the SML-OSA2 Appliances.
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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 or assistive tool for human readers. No MRMC study was conducted.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical intraoral appliance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the purposes of this 510(k) submission, the "ground truth" for the device's safety and effectiveness relies on the established safety and effectiveness of the predicate device (K130130) for its specified indications for use.
- The "ground truth" for the materials used in SML-OSA2 Appliances (including new ones like POM and latex elastomers) is established by their prior use in cleared dental/intraoral devices or their inclusion in the FDA Biomaterials Compendium.
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The sample size for the training set:
- Not applicable. This is not an algorithm or AI device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
In summary: The document from the FDA acknowledges a 510(k) premarket notification for the SML-OSA2 Appliances. It concludes that the device is substantially equivalent to a predicate device (ATG/SM-OSA Appliances, K130130), meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. This determination is made based on comparing the indications for use, technological characteristics (design, materials, scientific principle), and performance standards, primarily relying on existing data and prior clearances rather than new, extensive performance studies for the subject device. "No clinical testing is required for these 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.”