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.

AI/ML Overview

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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 21, 2016

SAS Oniris Mr. Thibault Vincent CEO 704 Avenue Roger Salengro Chaville, 92370 France

Re: K150566 Trade/Device Name: Oniris Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: February 8, 2016 Received: February 10, 2016

Dear Mr. Vincent:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use

Form Approved:	OMB No. 0910-0120
Expiration Date:	January 31, 2017
See PRA Statement below.

510(k) Number (if known)	K150566
Device Name	ONIRIS

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K150566

Device Trade Name : Oniris

Submitter:

SAS Oniris 147 avenue Paul Doumer 92500 RUEIL-MALMAISON FRANCE

Phone: +33 1 47 16 17 17 Fax: +1 47 16 20 11

Contact person: Thibault Vincent

Device Common Name : Mandibular advancement device

Date summary prepared : 18/03/2016

Device Classification Name : Intraoral Devices for snoring and obstructive sleep apnea

Device classification : Class II Product Classification : 872.5570 Product Code : LRK

Predicate devices:

Primary predicate : SomnoGuard® SP Soft. K121761 Reference predicates : Zquiet® Mouthpiece. K093407 SomnoGuard Series (SomnoGuard, 2.0, AP, and AP Pro). K061688

Description of the device :

Image /page/3/Picture/14 description: The image shows a clear plastic oral appliance. The appliance consists of two parts: a horseshoe-shaped piece that fits over the upper teeth and a rectangular piece that fits over the lower teeth. The two pieces are connected by two small plastic arms. The appliance is designed to be worn at night to help prevent teeth grinding and clenching.

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.

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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.

Intended use:

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

Technological characteristics compared to predicates

The principle of mandibular advancement for treatment of snoring/or obstructive sleep apnea is well known and there are a number of predicate devices. The advancement of the lower jaw, enables opening the upper airway and reduce snoring.

The Oniris Mandibular advancement device has the same technical characteristics as the primary predicate devices as summarized in table. Reference predicates supports substantial equivalence for the protrusion up to 11 mm and the possibility to mouth breath during device wearing.

	Oniris mandibularadvancementK150566	SomnoGuard® SPSoftK121761	Zquiet ®K093407Reference predicate	SomoGuard AP®K061688Reference predicate
Indications for use	The Oniris device isindicated in thetreatment of snoringand/or mild tomoderate obstructivesleep apnea in adults.	The SomnoGuard®SP Soft is intendedfor the treatment ofnight-time snoringand mild tomoderateobstructive sleepapnea (OSAS) inadults.	The ZQuietmandibularadvancementdevice is intendedfor the treatment ofnighttimesnoring in adults 18 years are older.	The SomnoGuard seriesof mandibularadvancement devices isintended for thetreatment of night-timesnoring and mild tomoderate obstructivesleep apnea (OSAS)in adults.
Dental impressions	« Boil & bite »appliance	« Boil & bite »appliance		« Boil & bite »appliance :
Mandibularadvancement	Oniris Device comeswith 9 connectors ofdifferent lengthenables up to 11mmprotusion	SomnoGuard® SPSoft with 6connectors ofdifferent lengthenables up to 10mm protusion	ZQuiet® employs abuccal cammechanism	SomnoGuard APcomprises two-parttitratable enables up to12 mm protusion.
Sterility	Non sterile	Non sterile	Non sterile	Non sterile
Design	Two independentthermoplastic trayslinked to each otherby a couplingprotrusionmechanism.	Two independentthermoplastic trayslinked to each otherby a couplingprotrusionmechanism.	Upper and lowerdental orthoticswith a buccal cammechanism.	SomnoGuard APconsists of twoindependentthermoplastic trays,both parts are linked toeach other by a couplingprotusion mechanism
Single patient use	X	X	X	X
Cleaned with waterand toothbrush daily	X	X	X	X
Interchangeable rods	Fixed by pressure onlower tray; angularrotation on pin tray	Fixed by pressureon lower and uppertray.

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The thermoplastic material used for tray is different, and the connecting mechanism of interchangeable rods Oniris device presents some differences compared to the primary predicate. The difference consists on larger shape stopper on lower tray to decrease the possibility of rod detachment. A slot has been added on the shape stopper to facilitate the fitting by pressure. The change of this rod is possible after angular rotation of the rod along its axis. This angular rotation is impossible to reproduce when wearing in mouth, and is a security to avoid detachment of rod during wearing.

On upper tray the rod is fitting like a key system, the rod rotate around the axis in order to reach the functional location, while the rod is fixed by pressure on the lower tray primary predicate.

The submission includes physical property specifications for materials used in the fabrication of the device, including density, tensile strain, tensile modulus, impact strength, softening temperature, melt flow rate, and Vicar Softening Point.

Clinical Data

In a one arm pilot study investigating the use of Oniris device in patients with moderate sleep apnea demonstrated a reduction of apnea index and oxygen desaturation index and was subjectively evaluated by patients to provide positive impact on snoring, morning fatigue and sleep quality.

Conclusions :

The Oniris device function is a similar manner to other comparative predicate devices and the intended use is the same. All are prescription devices indicated for patients suffering and/or mild to moderate obstructive apnea.

The information in this 510(k) submission demonstrate the Oniris device are substantially equivalent to the predicate devices. Fundamental scientific technology of the device is identical to the referenced predicate device. Rationale discussion on design differences of interchangeable rod has been conducted in the 510(k) Submission.

Regulation Number and Section

§ 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.”