(474 days)
The Sapphire Dorsal Comfort Fit Appliance is intended for use in patients 18 years of age or older for the reduction of night time snoring and mild to moderate obstructive sleep apnea.
The Sapphire Dorsal Comfort Fit Appliance is an intraoral device used for reducing snoring and mild to moderate obstructive sleep apnea. It consists of fitted trays which fit over the upper and lower teeth. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep and improves their ability to exchange air during sleep. The device is made for each patient and has an expansion screw adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.
The provided text describes a 510(k) premarket notification for the Sapphire Dorsal Comfort Fit Appliance. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study to establish new performance criteria. Therefore, the information requested regarding acceptance criteria, specific study designs, sample sizes for test/training sets, expert qualifications, and adjudication methods for evaluating an AI-powered device is largely not applicable in this context.
Here's an breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance:
This document does not establish new acceptance criteria as it's a 510(k) submission seeking substantial equivalence. The "performance" is demonstrated through non-clinical testing and comparison to predicate devices, showing that the new device is as safe and effective as existing ones.
Acceptance Criteria (Not explicitly stated as such, but inferred from testing and predicate comparison) | Reported Device Performance |
---|---|
Biocompatibility: Device materials are biocompatible (ISO 10993-1). | Biocompatibility testing (cytotoxicity, sensitization) was performed and confirmed compliance with ISO 10993-1. |
Material Strength/Durability: Mechanical properties of resin meet established standards (tensile, bend, fracture toughness, fatigue). | Resin samples were tested for tensile (ASTM D638-14), static three-point bend (ISO 20795), fatigue three-point bend (ISO 20795), and fracture toughness (ASTM D5045). Performance data on the base resin material was compared against the predicate material and found to be substantially equivalent, even with the "worst-case" comparison of the colored formula against the uncolored base resin. |
Device Integrity/Robustness: Full device assembly maintains integrity during common impacts (drop test). | The full device assembly was challenged in a drop test to assure integrity. (A similar off-the-shelf device, SnoreRx, was used for comparison due to difficulty acquiring the predicate device for this specific test.) |
Risk Mitigation: Device design addresses risks identified in relevant guidance documents. | The design of the Sapphire Dorsal Comfort Fit Appliance addresses the risks outlined in the Guidance Document: Class II Special Controls Guidance Document: Intraoral Device for Snoring and/or Sleep Apnea; Guidance for Industry and FDA issued on November 12, 2002. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. No clinical test set involving human patients was used for performance evaluation in the context of an "AI software" or "diagnostic" device. The testing described is for material properties and device integrity.
- Data Provenance: Not applicable. The testing was conducted on material samples and a prototype device "assembly."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No expert review for ground truth was established as this is not an AI/diagnostic device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device (intraoral appliance), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "ground truth" for this device's safety and effectiveness is established by demonstrating its material properties, design features, and intended use are substantially equivalent to already cleared predicate devices.
8. The sample size for the training set:
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
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.”