The HypnosPad of mandibular advancement devices is intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Device Description

HypnosPad (HP01) is a home-use mouthpiece and indicated for the treatment of night-time snoring. It is suitable for mild to moderate obstructive sleep apnea (OSA) patients in adults. The accessories of HyponsPad are a storage box and a spatula. The device is made by thermoflexible and biocompatible material. The usage method of HyponsPad is custom fit after hot water bathing. The duration of HypnosPad is about 8-10 hours contacting in patient's oral cavity. The HyponsPad is intended for holding the mandible in a protruded position thus maintaining the airway open during sleep. The HypnosPad will be used the spatula help to operate the device during boil and bite process. The HypnosPad will be stored in the storage box.

AI/ML Overview

The provided text describes the HypnosPad, an intraoral device for snoring and obstructive sleep apnea, and its substantial equivalence to a predicate device (SomnoGuard, K061688). However, it does not contain a study that directly proves the device meets specific performance acceptance criteria in terms of clinical effectiveness for treating snoring or sleep apnea.

The document primarily focuses on demonstrating substantial equivalence to the predicate device through comparisons of technological characteristics and various bench and usability tests. It does not provide clinical performance data with explicit acceptance criteria for treating the medical conditions it addresses.

Here's an analysis of the provided information based on your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., reduction in AHI, reduction in snoring events). Instead, the performance evaluation is based on demonstrating that the HypnosPad performs "as well as the noted predicate" in certain bench tests and usability, and that its technological characteristics are comparable, or differences do not raise new safety/effectiveness questions.

Characteristic / Test	Acceptance Criteria (Implicit)	Reported Device Performance
Intended Use	Identical to predicate: Treatment of night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.	Identical to predicate.
Mechanism of Action	Identical to predicate: Extends lower jaw, opening upper airway, reducing snoring and breathing arrests.	Identical to predicate.
Biocompatibility	Meets ISO 10993-1, 10993-5, 10993-10 standards.	Pass: Biocompatibility testing based on ISO 10993-1, 10993-5:2009 (in vitro cytotoxicity), and 10993-10:2010 (irritation and skin sensitization) were performed. (Reported as "Identical" to predicate's approach).
Usability	Meets IEC 62366:2007; differences from predicate do not introduce additional risk.	Pass: Usability test based on IEC 62366:2007 was performed. Differences in human factors (e.g., "Design - Oral appliance size and outward") did not raise additional risk based on usability test (Appendix D).
Mechanical Strength & Fitting Process	Performance comparable to predicate; differences don't introduce additional risk.	Pass: Bench test for performance for fitting process and mechanical strength was performed. Differences in "Design - Mandibular Advancement Range" and "Design - Patient Contacting Materials" did not raise additional risk based on this test and material property evaluation (Appendix F). The new device "performed as well as the noted predicate."
Material Properties	Performance comparable to predicate; differences don't introduce additional risk.	Pass: Material property evaluation was performed. Differences in "Design - Patient Contacting Materials" and "Material Thermal properties" did not raise additional risk. The new device "performed as well as the noted predicate."
Thermal Properties	Performance comparable to predicate; differences don't introduce additional risk.	Pass: Thermal property test was performed. Differences in "Material Thermal properties" did not raise additional risk based on Thermal Property Test Report (Appendix H). The new device "performed as well as the noted predicate."

2. Sample Size for the Test Set and Data Provenance

The document does not specify the sample size for any clinical test set, as no clinical performance study for the HypnosPad itself is presented in this summary.

For the bench tests, usability tests, and material property evaluations, the sample sizes are not explicitly stated, nor is the provenance of any data beyond what is implied by the testing standards (e.g., in-vitro cytotoxicity tests would involve cell cultures, mechanical tests would involve device units). There is no "country of origin of the data" or "retrospective/prospective" context for these engineering and safety tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided as there is no mention of a clinical study involving diagnosis or outcome assessment where experts would establish ground truth.

4. Adjudication Method for the Test Set

This information is not provided as there is no mention of a clinical study requiring adjudication of ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document does not describe any study comparing human readers' performance with and without AI assistance for this device, which is a physical medical device and not an AI-powered diagnostic tool.

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

No, a standalone performance study in the context of an algorithm or AI was not done. This device is a physical intraoral device, not a software algorithm.

7. The Type of Ground Truth Used

For the safety and performance tests mentioned (biocompatibility, usability, mechanical strength, material/thermal properties), the "ground truth" is established by adherence to recognized international standards (ISO, IEC) and performance benchmarks relative to the predicate device. There is no clinical "ground truth" (like expert consensus, pathology, or outcomes data) presented for the HypnosPad's effectiveness in treating sleep apnea or snoring.

8. The Sample Size for the Training Set

There is no mention of a training set as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set was Established

This point is not applicable as there is no training set mentioned.

In summary:

The provided K152660 document is a 510(k) summary demonstrating substantial equivalence of a physical medical device (HypnosPad) to a predicate. It relies on non-clinical performance data (bench testing, usability, biocompatibility) to establish that the new device is as safe and effective as the predicate. It does not contain a rigorous clinical study with specific acceptance criteria that would directly prove the device's efficacy in treating snoring or sleep apnea in a clinical population or the other types of performance criteria listed in your request related to AI or expert-driven assessments.

Summary

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

November 9, 2016

Somnics Inc. Tsung-Min Hsieh Manager, QA & RA 5F, No. 22, Sec. 2, Sheng Yi Rd., Hsinchu Science Park, Zhubei City Hsinchu County TAIWAN

Re: K152660

Trade/Device Name: HypnosPad Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea Regulatory Class: Class II Product Code: LRK Dated: September 30, 2016 Received: October 3, 2016

Dear Tsung-Min Hsieh:

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 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 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/Resourcesfor You/Industry/default.htm. 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 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. Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting 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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name

HypnosPad

Indications for Use (Describe)

The HypnosPad of mandibular advancement devices is intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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510(k) Summary

1. SUBMITTER

Company Name: Somincs Inc. Address: 5F, No.22, Sec. 2, Sheng Yi Rd, Hsinchu Science Park, Zhubei City, Hsinchu County 30261, Taiwan(R.O.C.) Contact Person: Tsung-Min Hsieh, QA/RA manger, Somnics, Inc. Phone: +886-3-550-9623-190 Fax: +886-3-550-3633 Email: tsungmin@somnics.com

Summary Preparing Date: October 11, 2016

II. DEVICE

Name of Device: HypnosPad, Model HP01 Common or Usual Name: Anti-Snoring / Sleep Apnea Device Classification Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea (21 CFR 872.5570) Device Classification: II Product Code: LRK Prior Submission: no prior submissions for the same device

III. PREDICATE DEVICE

SomnoGuard, K061688 This predicate has not been subject to a design-related recall in US.

No reference devices were used in this submission.

DEVICE DESCRIPTION IV.

HypnosPad (HP01) is a home-use mouthpiece and indicated for the treatment of night-time snoring. It is suitable for mild to moderate obstructive sleep apnea (OSA) patients in adults.

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The accessories of HyponsPad are a storage box and a spatula. ●
The device is made by thermoflexible and biocompatible material. ●
The usage method of HyponsPad is custom fit after hot water bathing.
The duration of HypnosPad is about 8-10 hours contacting in patient's oral cavity.
The HyponsPad is intended for holding the mandible in a protruded position thus maintaining the airway open during sleep.
The HypnosPad will be used the spatula help to operate the device during boil and bite process.
The HypnosPad will be stored in the storage box.
INDICATION FOR USE V.

The HypnosPad of mandibular advancement devices is intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VI. DEVICE
The proposed "HypnosPad" and the predicate are intended for the treatment of night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. Their indications for use, fundamental design, and technological characteristics are also comparable, as listed in the following table:

Device	HypnosPad (Model: HP01) – The Subject	Predicate Device SomnoGuard in SomnoGuard Series	Comparison
Intended Use & Indications for Use	Treatment of night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.	Treatment of night-time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.	Identical
Mechanism of Action	Extend the lower jaw, thereby opening the upper airway and reducing snoring and	Extend the lower jaw, thereby opening the upper airway and reducing snoring and	Identical
K152660/S001 additional information response
	the breathing arrestsdue to obstructivesleep apnea.	the breathing arrestsdue to obstructivesleep apnea.
OTC/PrescriptionUse	Prescription Use	Prescription Use	Identical
DeviceComposition	MAD Device,SpatulaStorage box	MAD DeviceSpatulaStorage box	Identical
Single Patient	Single patient	Single patient	Identical
Multiple Use	Multiple use	Multiple use	Identical
Treatment Time	Everyday overnight	Everyday overnight	Identical
Where Used	At home or clinicsetting(SleepLaboratories)	At home or clinicsetting(SleepLaboratories)	Identical
Design Concept	One piece designReady-to-UseUpper and low trays	One piece designReady-to-UseUpper and low trays	Identical
PersonalInterface ofCustomFabricated	Boil and bite fitting forPersonalizedproducts as a singlepatient multiple use	Boil and bite fitting forPersonalized productsas a single patientmultiple use	Identical
Design - PatientContactingMaterials	Thermoplasticelastomer	Thermoplasticelastomer	Purpose: Identical;Technology/spec:Difference, there isno additional riskbased on materialproperty evaluation(Appendix K), andPerformanceTesting Report forFitting Process andMechanical Strength(Appendix F).
Adjustable	Re-mold with lowerjaw extended but notin mechanism adjust.	Re-mold with lower jawextended but not inmechanism adjust.	Identical
			K152660/S001 additional information respc
Material Thermalproperties	Optimal thermoplasticcondition is large than67°C	Optimal thermoplasticcondition is large than60°C	Purpose: Identical;Technology/spec:Difference, there isno additional riskbased on ThermalProperty TestReport (AppendixH).
	Human Factors	Use during sleepperiod. User operatesboil and bite fitting atfirst time to use.	Use during sleepperiod. User operatesboil and bite fitting atfirst time to use.	Purpose: IdenticalTechnology/spec:Difference, there isno additional riskbased on usabilitytest (Appendix D).
		Design – Oralappliance sizeand outward	52mm x62.5mm x20.5mmFillet cushionLip seal curve	44.5mm x 63mm x25.5mmNANA	Purpose: IdenticalTechnology/spec:Difference, there isno additional riskbased on usabilitytest (Appendix D).
			Design –MandibularAdvancementRange	Up to 10 mmLimited mandibularadvancement.Patients with OSAshould be able toextend their lower jawforward at least 7mm	Limited mandibularadvancement. Patientswith sleep apneashould be able toextend their lower jawforward at least 7mm	Purpose: Identical;Technology/spec:Difference, there isno additional riskbased onPerformanceTesting Report forFitting Process andMechanical Strength(Appendix F).
SterilityRequirement				Non-sterile	Non-sterile	Identical
Biocompatibility				Biocompatibilitytesting based on ISO10993-1	Biocompatibility testingbased on ISO 10993-1	Identical

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Based on the testing results and relative technical information, the new device through these performance testing is substantially equivalent to the predicate.

VII. PERFORMANCE DATA

This device conforms to the standards and testing listed below:

· ISO 10993-1:2009: Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
· ISO 10993-5:2009: Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
· ISO 10993-10:2010: Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
Usability test (Based on IEC 62366:2007: Medical devices Application of usability engineering to medical device)
. Bench test for performance for fitting process and mechanical strength
Material property evaluation .
· Thermal property test
Comparative testing was done between the new device and the noted predicate device for . the material property evaluation, thermal property and the fitting process and mechanical strength. These performance data of the new device are demonstrated that the new device performed as well as the noted predicate.

Summary:

Based on the results of performance testing, HypnosPad was found to be as safe and as effective as the predicate.

VIII. CONCLUSION

The indication for use for the subject device is identical to the predicate device. The differences in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness. The performance data provided demonstrate that the device performs as intended and is as safe and as effective as the predicate device.

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.”