(632 days)
The Acrylic Herbst Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.
The Acrylic Herbst Appliance is comprised of upper and lower customized acrylic splints which are connected bilaterally via a telescoping Herbst mechanism for the treatment of mild to moderate sleep apnea. The device aims to improve the patient's air exchange thereby reduce snoring and apnea by increasing the pharyngeal space through anterior repositioning of the mandible.
The provided 510(k) summary for the GERGEN'S ORTHODONTIC LAB INC. Acrylic Herbst Appliance (K113126) does not include specific acceptance criteria or a dedicated study demonstrating the device meets quantitative performance metrics.
Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices based on technological characteristics and intended use. The document explicitly states: "Clinical testing of the subject device was not used in support of clearance."
Therefore, based on the provided text, I cannot complete the requested tables and sections with quantitative acceptance criteria or a study proving those criteria are met for performance of the device in its intended clinical use. However, I can extract information related to the device's technical characteristics and the comparison to predicate devices, which forms the basis of its clearance.
Here's a breakdown of what can be inferred from the provided text regarding the closest equivalent to "acceptance criteria" and "study":
1. Table of Acceptance Criteria and Reported Device Performance
As noted, there are no quantitative clinical acceptance criteria or reported clinical performance metrics for the subject device in this document. The "performance data" mentioned refers only to material properties.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as presented in the 510(k) summary) |
|---|---|
| Device has the same intended use as predicate devices. | Intended Use: The Acrylic Herbst Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older. |
| (This matches the intended use of predicate devices). | |
| Device has the same technological characteristics as predicate devices (design, function, materials, adjustability, manufacturing method, sterility). | Technological Characteristics: The Acrylic Herbst Appliance shares the same basic design (upper and lower trays with bilateral Herbst mechanisms), function (increase pharyngeal space by anterior mandibular repositioning), materials (medical grade acrylic and stainless steel), adjustability, method of manufacture (customized), and sterility (non-sterile) as its predicate devices. |
| Device material properties are suitable. | Material Properties: Data supporting general properties (water solubility and absorption) and physical properties (tensile and flexural strength, and elastic modulus) were provided. (Specific values are not detailed in the summary). |
| Device poses no new safety concerns. | Risk Analysis: A risk analysis found no new safety concerns specific to the Gergen's Orthodontic Acrylic Herbst Appliance. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. No clinical test set was used for the subject device's clearance. The clearance is based on substantial equivalence to predicate devices, not on a direct clinical study of the subject device.
- Data Provenance: Not applicable for a clinical test set. The data provenance for material properties is not specified beyond "provided in support of clearance."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set was used for this device's clearance.
4. Adjudication method for the test set
- Not applicable. No clinical test set was used for this device's clearance.
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 an anti-snoring appliance, not an AI-powered diagnostic tool, and no MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used
- Not applicable for clinical performance. The "ground truth" for the device's clearance is its demonstrated similarity in intended use and technological characteristics to legally marketed predicate devices, which are presumed safe and effective.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML algorithm.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" that proves the device meets "acceptance criteria" (in the context of this 510(k) submission) is a comparison to predicate devices (Allesee Orthodontic Appliances, Inc. (K070327), Specialty Appliances Works, Inc. (K083209), Dynaflex Inc. (K103076), and Embassy Dental (K111009)). The submission states:
"Clinical testing of the subject device was not used in support of clearance."
"The fundamental scientific technology of the Gergen's Orthodontic Acrylic Herbst Appliance is the same as previously cleared devices... i.e., each of the design features is common to one or more of the predicate devices."
"In comparison to the predicate devices, the Acrylic Herbst Appliance has
- the same intended use (as described above),
- the same technological characteristics (as described above)
and so does not raise new questions of safety and effectiveness."
Therefore, the "proof" is the argument for substantial equivalence based on shared fundamental technology, intended use, and material properties, rather than direct clinical performance data for the subject device itself.
§ 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.”