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The Oniris device is indicated in the treatment of snoring and/or mild to moderate obstructive sleep apnea in adults.

The Oniris Mandibular advancement device is an intraoral device for use during up to 8 hours of sleep, and composed of two injection molded thermoplastic trays overmoulded with thermoforming resin and customized to fit over the patient's teeth. The trays are attached and articulated through interconnecting rods to allow for mandibular advancement in relation to the maxilla up to 11 mm of protrusion. Mandibular advancement is the mechanism of action to increase upper airway opening to reduce snoring and mild to moderate sleep apnea.

The Oniris device is formed to upper and lower teeth without the need of taking a patient's dental impressions. Oniris device is a "boil-&-bite" device, the trays are customizable.

This mandibular advancement device maintains performance for 12 to 24 months depending on its conditions of use and maintenance as well as the patient's salivary composition.

Oniris mandibular device is proposed in two sizes to be adapted to different sizes of jaw (size 2 in the same box). The practitioner/dentist has to choose the most comfortable size for the patient.

The provided text describes the Oniris mandibular advancement device, which is indicated for the treatment of snoring and/or mild to moderate obstructive sleep apnea in adults. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria with reported device performance.

Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not available in the provided document.

However, based on the Clinical Data section, we can infer some details about a pilot study.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical endpoints. The overall "acceptance criteria" for regulatory clearance is substantial equivalence to predicate devices, which is demonstrated through comparable intended use, technological characteristics, and safety and effectiveness.
• Reported Device Performance:
  • Reduction of apnea index.
  • Reduction of oxygen desaturation index.
  • Subjectively evaluated by patients to provide positive impact on snoring, morning fatigue, and sleep quality.

2. Sample sized used for the test set and the data provenance

• Sample Size: Not specified beyond "patients" in a "one arm pilot study."
• Data Provenance: The study was a "pilot study" but its location or whether it was retrospective or prospective is not explicitly stated. Given it's a "pilot study investigating the use of Oniris device," it implies a prospective study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
• The "ground truth" for sleep apnea and oxygen desaturation would typically be established by polysomnography (PSG) studies interpreted by sleep specialists, but this is not detailed for this pilot study.

4. Adjudication method for the test set

• Not specified.

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

• No, this device is a physical intraoral device, not an AI software. Therefore, an MRMC study related to AI performance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No, this is a physical medical device, not an algorithm.

7. The type of ground truth used

• Based on the reported performance metrics (reduction of apnea index and oxygen desaturation index), the ground truth for the physiological measurements would likely be derived from sleep studies (e.g., polysomnography findings).
• For subjective claims (snoring, morning fatigue, sleep quality), the ground truth is patient self-report/feedback.

8. The sample size for the training set

• Not applicable as this is a physical device and not an AI algorithm that undergoes a training phase.

9. How the ground truth for the training set was established

• Not applicable.

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