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510(k) Data Aggregation
(87 days)
Oravan Herbst is intended to reduce snoring and mild to moderate sleep apnea in adults.
The Oravan Herbst is intended to reduce snoring and mild to moderate sleep apnea in adults. It is made of orthodontic acrylic trays and herbst assembly. It has two acrylic pieces - the upper acrylic tray that fits over the top posterior teeth and the lower acrylic tray that fits over the bottom posterior teeth. The herbst assembly provides a standard titration mechanism and enables mandibular advancement. With this design, the Oravan Herbst allows the physician to increase the patient's pharyngeal opening, improving their ability to exchange air during sleep and reduce vibrations. Each Oravan Herbst device is patient-specific (customized for each patient).
The device in question is the Oravan Herbst, an intraoral device intended to reduce snoring and mild to moderate sleep apnea in adults.
Here's an analysis based on the provided text, addressing the points requested:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present specific acceptance criteria in terms of clinical performance metrics (e.g., AHI reduction, success rate) or a "reported device performance" in a clinical context. Instead, the substantial equivalence relies on:
| Acceptance Criteria Category | Specific Criteria (Implicitly Met) | Reported Device Performance (as demonstrated for substantial equivalence) |
|---|---|---|
| Intended Use | Reduction of snoring and mild to moderate sleep apnea in adults. | Oravan Herbst is intended for this use, matching predicate devices. |
| Technological Characteristics | Similar fundamental scientific technology, design, and materials to predicate devices (SomnoDent Herbst K130558 and Oravan OSA K121285). The key difference in adjustment mechanism (Herbst style vs. expansion screws) is deemed minor and not raising new concerns for equivalence, as both achieve mandibular advancement. | Device Components/Parts: Orthodontic Acrylic trays, Herbst Assembly, Wire with ball clasps, Allen key (Matches SomnoDent Herbst). |
| Device Configuration: Two-piece design, upper and lower acrylic trays covering posterior teeth (Matches both predicates). | ||
| Device Functionality: Mandibular advancement to increase pharyngeal opening, improve air exchange, reduce vibrations (Matches both predicates). | ||
| Mandibular Advancement Range: Up to 5mm for Oravan Herbst (Matches SomnoDent Herbst, Oravan OSA is 6mm, considered minor difference). | ||
| Materials: Medical grade Polymethylmethacrylate, Medical Grade Stainless Steel for wire with ball clasps and Herbst assembly (Matches both predicates). No colorants used. | ||
| Non-Clinical Data | Physical properties of orthodontic acrylic material in accordance with ISO 20795-2:2005. Risk analysis performed per ISO 14971, with acceptable hazards. | Physical properties of orthodontic acrylic material meet ISO 20795-2:2005 (same as K121285). Risk analysis demonstrates hazards are acceptable based on biocompatible materials, well-characterized design, labeling, and performance testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The submission states, "The submission does not rely on any clinical data; therefore no clinical testing was performed." This means there was no test set of patient data used to evaluate the device clinically. The evaluation was based on non-clinical data and comparison to predicate devices.
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)
Since no clinical data or clinical testing was performed, there was no test set requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used.
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 intraoral appliance, not an AI-powered diagnostic tool, and no MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical studies were performed. The "ground truth" for substantial equivalence was primarily based on established standards (e.g., ISO for materials) and the characteristics of legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
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