(109 days)
The Removable Acrylic Herbst is intended to be used for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.
The Allesee Snore Appliance (ASA) is intended to be used for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.
The Enoch Snorinator is intended to be used for the reduction of snoring and mild to modcrate obstructive sleep apnea (OSA) by repositioning the lower jaw into a prescribed relationship to the upper jaw.
The Removable Acrylic Herbst appliance is an upper and lower arch system designed to hold the lower jaw forward which increases the lower airway passage and reduces the tendency to snore. The upper and lower appliances are connected by means of a telescoping male and female stainless steel tube (upper) and rod (lower) Herbst mechanism. The system is bilateral, left and right. While the patient can open and close their mouth, the lower jaw arcs as predetermined by the construction of the appliance. The degree to which the patient's lower jaw is supported in an anterior position is determined by the dentist.
The Enoch Snorinator is a one-piece appliance designed for the upper arch only. It is a pressureformed anterior repositioning splint which postures the lower jaw forward to alleviate snoring. The anterior portion is formed into a "ramp" shape to engage the lower incisors. This ramp postures the lower jaw into the prescribed position as determined by the dentist.
The Allesee Snore Appliance (ASA) is a one-piece upper and lower, pressure-formed splint. The upper and lower jaw plastic appliances are joined together with orthodontic acrylic. The appliance postures the patient's lower jaw in a forward or anterior position. The amount of advancement is patient specific and determined by the dentist. The appliance has a rectangular airway between the upper and lower anterior teeth.
The provided document K070327 is a 510(k) premarket notification for several intraoral devices intended for the reduction of snoring and mild to moderate obstructive sleep apnea (OSA). A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed performance studies or acceptance criteria with specific metrics from clinical trials, especially when not a novel device requiring such studies.
Based on the information provided, there is no specific study described that outlines acceptance criteria in terms of quantifiable performance metrics (e.g., sensitivity, specificity, accuracy) and then proves the device meets these criteria with statistical data. The document primarily focuses on establishing "substantial equivalence" to predicate devices based on intended use, device description, principle of operation, materials, and technological characteristics.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert ground truth, and comparative effectiveness studies are not present within this 510(k) summary.
Here's an attempt to answer the questions based only on the provided text, acknowledging that much of the requested information is not available in a typical 510(k) submission focused on substantial equivalence:
1. A table of acceptance criteria and the reported device performance
No specific, quantifiable acceptance criteria or reported device performance metrics (e.g., in terms of snoring reduction percentage, AHI reduction) are stated in this 510(k) document for the devices Removable Acrylic Herbst, Allesee Snore Appliance (ASA), or Enoch Snorinator.
The "acceptance criteria" in the context of a 510(k) submission for these devices typically revolve around demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as the predicate. This is proven by similarity in:
- Intended Use: All devices share the intended use of reducing snoring and mild to moderate OSA by repositioning the lower jaw.
- Technological Characteristics: All devices are intraoral appliances designed to move the lower jaw forward.
- Materials: Implied to be similar to legally marketed devices (e.g., acrylic, stainless steel).
- Performance: Implied to be similar to legally marketed devices in their ability to reposition the jaw and alleviate snoring/OSA symptoms, although no specific performance data is presented.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The document does not describe a clinical test set or performance study for these specific devices. The basis for substantial equivalence is comparison to predicate devices, not specific clinical performance data from a new study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is described as there is no reported test set or clinical study for these devices.
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. These are mechanical intraoral devices, not AI-powered diagnostic or assistive tools. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. These are physical medical devices, not algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The substantial equivalence determination relies on comparing the device's characteristics and intended use to existing, legally marketed predicate devices, not on a new clinical ground truth establishment for novel performance claims.
8. The sample size for the training set
Not applicable. No training set is described as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. No training set or associated ground truth establishment is described.
Summary of Device and Predicate Information Present in the Document:
The 510(k) submission K070327 is for three intraoral devices:
- Removable Acrylic Herbst
- Intended Use: Reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw.
- Substantial Equivalence Claimed to: State University of New York at Buffalo, School of Dental Medicine, Removable Herbst Appliance.
- Enoch Snorinator
- Intended Use: Reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw.
- Substantial Equivalence Claimed to: Hays & Meade Inc., Snore Guard.
- Allesee Snore Appliance (ASA)
- Intended Use: Reduction of snoring and mild to moderate obstructive sleep apnea (OSA) by repositioning the lower jaw.
- Substantial Equivalence Claimed to: Great Lakes Orthodontic Laboratory, NAPA Appliance.
In all cases, substantial equivalence is claimed based on similarities in intended use and device characteristics to predicate devices already on the market, which is a common pathway for mechanical medical devices in a 510(k) submission. The FDA's letter states that they reviewed the submission and determined "the device is substantially equivalent... for the indications for use stated in the enclosure." This administrative determination of substantial equivalence, rather than a clinical performance study with specific metrics, is the "proof" the document refers to.
§ 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.”