The attachment is at a 40 degree angle to enable movement of the appliances, thus patient can open and close while wearing the appliances. The appliance is open in the front and allowing the patient to inhale and exhale more air per breath.

The RH Associates obstructive sleep apnea appliance "Nu-Sleep" is offered in Hard/Soft which has a dual laminate layer that provides a soft layer on the tooth surface which is made of acrylic.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Nu Sleep device, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating similarity or equivalence to predicate devices in terms of reducing snoring and apneic events. The reported device performance is presented as "success rate of reduction of snoring and the success rate of reduction of apneic events measured by polysomnograms." No specific percentage or numerical target for success is provided, nor is the "success rate" itself quantified in the document.

Therefore, the table below reflects what can be inferred from the provided text.

Acceptance Criteria (Inferred from equivalence claim)	Reported Device Performance (as stated)
Reduction of snoring similar to predicate devices	Demonstrated "success rate of reduction of snoring"
Reduction of apneic events similar to predicate devices	Demonstrated "success rate of reduction of apneic events"

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 31 patients.
- Data Provenance: The study was conducted at "one facility." The country of origin is not explicitly stated. It was a prospective study, as observations were made in two stages (without and with the appliance).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The study mentions "Objective criteria have been observed and have been measured," referring to RDI, AHI, and ODI, typically captured via polysomnography, which is interpreted by trained professionals. However, the number and qualifications of individuals interpreting these results or establishing the "ground truth" for the study's claims are not detailed.
Adjudication method for the test set:
- This information is not provided in the document.
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 MRMC study was performed or mentioned. This device is an intraoral appliance, not an AI or imaging diagnostic tool that would typically involve human reader evaluation of AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a medical device (intraoral appliance) and not an algorithm or AI system. Its performance is demonstrated with a human-in-the-loop (the patient wearing the device).
The type of ground truth used:
- For the clinical evaluation, the ground truth was established by objective polysomnographic measurements: RDI (Respiratory Disturbance Index), AHI (Apnea-Hypopnea Index), and ODI (Oxygen Desaturation Index).
The sample size for the training set:
- This is not an AI/machine learning device, so there is no concept of a "training set" in the context of this submission. The "training" here refers to the development process of the physical device itself, not an algorithm.
How the ground truth for the training set was established:
- Not applicable, as there is no training set in the context of an algorithm. For the device development, the "ground truth" would be engineering specifications, material properties, and prior knowledge from predicate devices used in its design.

Summary

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ERLI MEDICAL REGISTRATION

SECTION 5.................. 510(k) Summary (21.CEB 807.92)

510(k) Number K 481344

1	Submission Owner	RH Associates LLC257 Middle Country Rd.Smithtown, 11787 NYPhone 631-724-4664Fax 631-360-7880
2	Official CorrespondentContact Person	Sterling Medical RegistrationDaniela Levy - Regulatory Consultant22817 Ventura Blvd#161Woodland Hills, 91364 CAPhone 213-787-3026Phone 213-447-5297Web www.sterlingmedicalregistration.com
3	Submission Date	February 2012
4	Device Trade Name	Nu Sleep
5	Regulation Description	Intraoral devices for snoring and intraoral devicesfor snoring and obstructive sleep apnea (OSA)
6	Classification	Device Name : Device, Anti-SnoringProduct Code : LRKRegulation No : 872.5570Class : IIPanel : Dental
7	Reason for the Premarket Notification Submission	New Device

ס״ד

OCT 1 7 2012

Identification of Legally Marketed Predicate Devices : 8
ﻟ

. -

· · Nu Sleep appliance is substantially equivalent to Respire Blue Series K111207;
Somnomed MAS Flex S K073004; EMA K971794; in terms of intended use, い

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ס״ר

FERLING MEDICAL REGISTRATION

indication for use, technological characteristics, performance and user interface. The predicate devices are Class II medical devices.

Device Description ರಿ
Nu Sleep appliance is a patient specific made device for each patient which consists of two dental plates, upper and lower, made of Acrylic.

The RH Associates obstructive sleep apnea appliance "Nu-Sleep" is offered in Hard/Soft which has a dual laminate layer that provides a soft layer on the tooth surface which is made of acrylic.

10 Intended use

The Nu Sleep appliance is indicated to treat mild to moderate Obstructive Sleep . Apnea.

11 Performance Standards or Special Controls

Recognized Consensus Standard: ISO 7405:2008 Dentistry Evaluation of . biocompatibility of medical devices used in dentistry

Substantial Equivalent Table	CandidateNU SleepDevice	Respire Blue Series(Hard/Soft Surface)	EMA	SomnomedFlex S
510k Number		K111207	K971794	K073004
Company Name	RHAssociatesLLC	Respire Medical LLC	Frantz DesignIncorporated	SomnomedInc
Intended Use
Intended as an intraoral device	YES	YES	YES	YES
Intended to reduce snoring orhelp alleviate snoring	YES	YES	YES	YES
Treatment of mild to moderateobstructive sleep apnea	YES	YES	YES	YES
Indicated for single patient multi -use	YES	YES	YES	YES
Indicated for use at home or sleeplabratories	YES	YES	YES	YES
Target population - Adultspatients	YES	YES	YES	YES
Prescription Device	YES	YES	YES	YES

12 Substantial Equivalence

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ס״ד

Design
Rigid tray pieces	YES	YES	YES	YES
Separate tray pieces	YES	YES	YES	YES
patient specific fit for each patient	YES	YES	YES	YES
Works by mandibularadvancement	YES	YES	YES	YES
Can be adjusted or refit	YES	YES	YES	YES
Placed in patient mouth eachevening	YES	YES	YES	YES
Cleaned daily	YES	YES	YES	YES
Easily removed from mouth	YES	YES	YES	YES
Lower jaw adjustment using asupplied adjustment key	YES	YES	YES	YES
Upper and lower tray unhook foreasy removal from mouth	YES	YES	YES	YES
Permits patients to breat throughmouth	YES	YES	YES	YES
Material
Trays constructed from moldedhard acrylic and ball clasps	YES	YES	YES	NO
Trays constructed from a softlining material adhered to a hardsurface acrylic	YES	YES[No for hard]	NO	YES
Trays constructed from a heatsensitive impermissible materialfor fitting to teeth	NO	NO	NO	NO
Non Sterile	YES	YES	YES	YES

Summary of Equivalence: Nu Sleep appliance is substantially equivalent to Respire Blue Series K111207; Somnomed MAS Flex SK073004 and EMA K971794 devices. As similar to its predicate device Nu Sleep appliance is a patient specific made device, consists of two parts, upper and lower trays, made of acrylic.

Nu Sleep differs from both the Respire Blue and the Somnomed in that the both require a very rigged plastic to handle the forces applied to the acrylic wings. Nu Sleep utilizes steel to handle the forces so that the contact position can be placed further back in the mouth.

The design differences emphasis the advantages of Nu Sleep technology. Nu Sleep shares the same technological characteristics as its predicate devices and thus, the Nu Sleep appliance is substantially equivalent to its predicate devices.

Risk Assessment performance to ensure the safety and effectiveness related to the appliances.

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ס״ד

MEDICAL REGISTRATION

Bench testing - Comparable Chemical Structure testing was conducted with Nu Sleep and its predicate devices. Test results have demonstrated the equivalent and/or similarity of Nu Sleep to its predicate devices. Thus, Nu Sleep appliance shares similarity with its predicate devices.

GPC testing was conducted in order to determine the molecular weight and the molecular weight distribution. Test results have met all acceptable criteria.

Clinical evaluation study was conducted on 31 patients, female & male, at one facility. The study observation was conducted in two stages, stage one without the appliance, stage two with the appliance. Objective criteria have been observed and have been measured, such as: total sleep, RDI, AHI, ODI, at both stages. Clinical evaluation and observation results have demonstrated the success rate of reduction of snoring and the success rate of reduction of apneic events measured by polysomnograms. Thus, Nu Sleep appliance shares similarity in the indication of use to its predicate devices.

Conclusion:

As verified by clinical and non clinical data, bench testing and substantial equivalence table, Nu Sleep appliance shares similarity with its predicated device by term of intended use, raw material and technical design. The fundamental scientific technology of the device is identical or very similar to the referenced predicate devices, thus Nu Sleep appliance is considered to be substantially equivalent to the its predicates devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized design featuring what appears to be an abstract representation of people or human figures.

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

OCT 17 2012

RH Associates, Limited Liability Company C/O Daniela Levy Regulatory Consultant Sterling Medical Registration 22817 Ventura Boulevard # 161 Woodland Hills, California 91364

Re: K121344

Trade/Device Name: Nu Sleep 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: September 13, 2012 Received: September 17, 2012

Dear Ms. Levy:

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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Page 2- Ms. Levy

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 device-related 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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RLI MEDICAL REGISTRATION

SECTION 4 - Indication for Use Statement

Indications for Use

510(k) Number (if known): _ K121344

Device Name:

Nu Sleep

Indications for Use:

The Nu Sleep appliance is indicated to treat mild to moderate Obstructive Sleep Apnea.

Prescription Use _ > (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shoar Raman

Isian Stan-Off of Anesthesiology, General Hospital Infection Control, Dental I

Page 1 of _

510(k) Number:

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.”