(156 days)
The Emerald Herbst appliance is intended to treat snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adults 18 years of age or older.
The Emerald Herbst appliance is a customized oral device featuring both lower and upper trays and interlocking system. The product is non-sterile, biocompatible, and provided in a sealed box with instructions for use and an adjustment screw. The upper and lower trays are connected by an adjustable hinge allowing the patient to open and close the mouth while wearing the appliance. The Herbst Telescopic Hardware on the side of the device allows the patient to move forward and left and right but not backwards. This freedom of movement is important for comfort and overall success of the device.
The Emerald Herbst appliance is intended to treat snoring and mild to moderate sleep apnea (OSA) in adults 18 years of age or older by guiding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway.
The Emerald Herbst is offered in two options:
- Hard devices which are all acrylic and retained with ball clasps that allow the device to be tightened if it becomes loose.
- Hard / Soft which has a laminate layer that provides a soft layer on the tooth surface.
The provided document is a 510(k) premarket notification for a medical device called the "Emerald Herbst" oral appliance, intended for the treatment of snoring and mild to moderate Obstructive Sleep Apnea (OSA). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new device-specific clinical trials to prove safety and effectiveness. Therefore, the information regarding acceptance criteria and a study that proves the device meets these criteria will be different from what would be expected for a device requiring new clinical evidence.
Here's an analysis of the acceptance criteria and the "study" (or rather, the justification for equivalence) based on the provided text:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission, the "acceptance criteria" are primarily established by the characteristics and performance of the predicate device. The goal is to show that the new device is "substantially equivalent" to an existing one. The provided document includes a "Substantial Equivalence Table" which acts as a comparison of key characteristics between the subject device (Emerald Herbst) and its predicate devices (Respire Pink Series Herbst and Herbst EF).
| Feature / Acceptance Criteria (based on Predicate) | Reported Emerald Herbst Performance |
|---|---|
| Intended Use: | |
| Treat snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adults 18+ | Intended to treat snoring and mild to moderate obstructive sleep apnea (OSA) in adult patients 18+ |
| Class II medical device | Class II |
| Intraoral device | Yes |
| Reduce snoring | Yes |
| Treat mild to moderate OSA | Yes |
| Nighttime use | Yes |
| Single patient, multiuse | Yes |
| Use at home or sleep labs | Yes |
| For adults, 18 years or older | Yes |
| Design: | |
| Customized fit for each patient | Yes |
| Mechanism of action: Mandibular advancement | Yes |
| Can be adjusted or refit | Yes |
| Range of forward movement of mandible | Yes (implicitly, as it uses the same Herbst telescoping hinge) |
| Upper & lower trays disengage for easy removal | Yes |
| Permits patient to breathe through the mouth | Yes |
| Has tracking device | No (this is a difference from one predicate, but not deemed to impact substantial equivalence here) |
| Cleaned and inspected daily by patient | Yes |
| Materials: | |
| Hard surface material | Yes |
| Soft lining material | No (for Hard option), Yes (for Hard/Soft option) |
| Advancement mechanism (Herbst telescoping hinge, stainless steel) | Yes |
| Cobalt Chrome Mesh inside Acrylic | Yes |
| Mechanism: | |
| Mechanism of Action: Mandibular Advancement | Mandibular Advancement |
| Method of Positioning the Mandible: Herbst Telescoping Hinge | Herbst Telescoping Hinge |
| Maximum Amount of Mandible Protrusion: 6 mm | 6 mm |
| Labeling: | |
| Prescription Only | Yes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not involve a "test set" in the sense of a clinical study with a patient cohort. The "study" here is a demonstration of substantial equivalence through comparison of design, materials, and function to a predicate device. Therefore, clinical sample sizes, data provenance (country, retrospective/prospective), expert ground truth, and adjudication methods are not applicable in the traditional sense for this 510(k). The evaluation is based on manufacturer data, existing predicate device information, and bench testing.
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. As described in #2, there was no clinical "test set" requiring expert ground truth or adjudication.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described in #2, there was no clinical "test set" requiring 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 or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The ground truth for this submission is the established safety and effectiveness of the predicate devices and the physical/material properties of the subject device. The primary "ground truth" demonstrated is that the Emerald Herbst appliance is made of the same materials, using the same manufacturing procedures, and has the same mechanism of action as the legally marketed predicate devices, and therefore is expected to have the same performance.
8. The sample size for the training set
Not applicable. There is no AI component or "training set" for this device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there's no ground truth for it to be established.
Summary of the Study/Justification provided in the text:
The "study" or evidence provided to meet acceptance criteria for the Emerald Herbst device is primarily a demonstration of substantial equivalence to existing predicate devices (Respire Pink Series Herbst and Herbst EF).
- Clinical and Non-Clinical Data: A biocompatibility and physical properties assessment was completed. This assessment concluded that the subject device was substantially equivalent to the primary predicate device based on its material composition. A risk assessment was also conducted, concluding no additional risks compared to the predicate device(s).
- Performance Testing: The document states that the Emerald Herbst is "equivalent to the predicate device, Pink Series, as it uses all the same materials, same manufacturing procedure and same manufacturer." Therefore, no mechanical testing was conducted to establish equivalence in general. However, specific performance testing mentioned is:
- The Emerald Herbst was subjected to pre and post accelerated aging test measured by deflection strength. The result was that "Aging did not decrease the strength of the device."
- Differences: The only significant difference highlighted is the color (green vs. pink). This difference was justified by referencing another cleared device (K942667) that includes the use of various colors, including the green used for Emerald Herbst.
In essence, the "study" establishing that the Emerald Herbst meets acceptance criteria is a regulatory comparison and material/design verification, rather than a clinical trial or algorithm performance study. The acceptance criteria are "to be substantially equivalent to the predicate device" in terms of intended use, technological characteristics, and safety/effectiveness profile, which is achieved by demonstrating identical or very similar materials, design, mechanism of action, and manufacturing processes, with any minor differences (like color) being justified.
§ 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.”