(312 days)
Oravan OSA is intended to reduce snoring and mild to moderate sleep apnea in adults
The Oravan OSA has been developed for the treatment of mild to moderate obstructive sleep apnea. Each Oravan device is made for each individual patient. There are two unique acrylic pieces that fit over the top and bottom teeth. The Oravan is fully adjustable for maximum benefit to treat the symptoms of obstructive sleep apnea and snoring. The Oravan sleek design allows for comfortable mandibular movement. The Oravan is made of orthodontic acrylic. Each device is warranted for 2 full years against breakage from everyday use.
The Oravan OSA device, an anti-snoring and mild to moderate sleep apnea treatment, established substantial equivalence through non-clinical data rather than through a study proving it meets specific acceptance criteria based on patient outcomes.
The submission does not include a table of acceptance criteria and reported device performance in the typical sense for a clinical study comparing an AI device to a ground truth. Instead, the focus is on demonstrating that the materials used in the device meet existing standards.
Here's a breakdown of the information that can be extracted from the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Material Properties) |
|---|---|
| ISO 20795-2:2005 - Dentistry -- Base polymers -- Part 2: Orthodontic base polymers (Requirements and limits for physical properties) | The physical properties of the Orthodontic Acrylic material used in the Oravan OSA are in accordance with this standard. |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not applicable. No clinical test set was used for performance evaluation of the device's therapeutic effectiveness. The "test set" here refers to the material samples evaluated against the ISO standard. The size of this material sample set is not specified.
- Data provenance: Not explicitly stated, but implicitly derived from manufacturer testing of their raw materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable. The "ground truth" for the material properties was established by adherence to the objective criteria outlined in the ISO standard, not by expert consensus on clinical outcomes.
4. Adjudication method for the test set
- Adjudication method: Not applicable for clinical endpoints. For material properties, the "adjudication" is based on whether the measured physical properties of the orthodontic acrylic met the specifications of ISO 20795-2:2005.
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
- MRMC study: No. This is not an AI device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Type of ground truth: For the material safety and performance, the ground truth was established by compliance with an international standard (ISO 20795-2:2005) for orthodontic base polymers. There was no clinical ground truth established for the device's effectiveness in reducing snoring or sleep apnea as no clinical testing was performed or required for substantial equivalence.
8. The sample size for the training set
- Sample size for the training set: Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
- How the ground truth for the training set was established: Not applicable. This is not an AI device.
Study Proving Acceptance Criteria:
The study proving the device meets its "acceptance criteria" (in the context of this 510(k) submission) is a non-clinical study evaluating the physical properties of the Orthodontic Acrylic material.
- Methodology: The submission states that the physical properties of the orthodontic acrylic material used in the Oravan OSA were tested against the requirements and limits specified in the international standard ISO 20795-2:2005 - Dentistry -- Base polymers -- Part 2: Orthodontic base polymers.
- Outcome: The manufacturer reported that these physical properties were "in accordance with" the specified requirements and limits of the standard. This demonstrates that the material used is suitable for its intended purpose and meets established safety and performance benchmarks for dental materials.
The entire 510(k) submission relies on demonstrating substantial equivalence to existing predicate devices (Somnomed MAS RxA K050592 and The Moses Appliance K093710) by comparing their indications for use, technological characteristics, design, and materials. The non-clinical material testing supports the safety of the chosen material (orthodontic acrylic) by confirming its compliance with a relevant ISO standard. No clinical data or performance studies on the device's effectiveness in patients were submitted or required for this clearance.
§ 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.”