The provided document for the "OASYS-ORAL AIRWAY SYSTEM" (K030440) does not contain detailed acceptance criteria or a specific study proving the device meets quantitative performance metrics. This is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to predicate devices rather than proving novel safety and effectiveness through extensive clinical trials with predefined acceptance criteria.

The document primarily highlights the device's technical characteristics and intended use, comparing them qualitatively to predicate devices. There are no quantifiable performance metrics, sample sizes, expert ground truth details, or statistical analyses typically associated with proving acceptance criteria.

Therefore, I cannot populate the requested table and answer the study-related questions quantitatively based on the information provided. The document specifically states: "Literature supports the historical significance of oral devices that reposition the mandible and reduce and manage snoring as well as sleep apnea." This implies reliance on existing knowledge and predicate device performance rather than dedicated efficacy studies for this specific device in this submission.

However, I can extract information related to the device's intended use and the comparison to predicate devices, which implicitly serves as the "acceptance criteria" in a 510(k) context – demonstrating that the new device is as safe and effective as existing legally marketed devices.

Summary of Information from the Provided Document (K030440):

Since no specific acceptance criteria with quantifiable metrics and associated study data are presented in this 510(k) summary, I will interpret "acceptance criteria" in the context of a 510(k) submission as the attributes and intended uses for which the device needs to demonstrate substantial equivalence to its predicates. The "reported device performance" would then be its conformance to these attributes and uses as stated in the comparison.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Attribute/Intended Use)	Reported Device Performance (OASYS K030440)
Intended Use:
Indicated as an intraoral device	Yes
Intended to reduce or help snoring	Yes (stated, and implied by comparison to predicates with this indication)
Indicated for use with persons who snore	Yes (stated, and implied by comparison to predicates with this indication)
Indicated to reduce or alleviate obstructive sleep apnea (OSA)	Yes (stated, and implied by comparison to predicates with this indication)
Indicated for single patient, multi-use	Yes
Indicated for use at home or sleep laboratories	Yes
Design Characteristics:
Heat sensitive impressible material for fitting to teeth	Yes
Custom fit for each user	Yes
Can be adjusted or refit	Yes
Placed in users mouth each evening	Yes
Cleaned daily	Yes
Easily removed from mouth	Yes
Permits user to breathe through mouth	Yes
Prevents grinding of teeth	Yes
Materials:
Heat sensitive impression material	Yes
Rigid tray	Yes
Non-Sterile	Yes
Safety and Effectiveness:	The submission states: "This difference [nasal dilators] does not have a significant effect on the safety or effectiveness of the device." and "Literature supports the historical significance of oral devices that reposition the mandible and reduce and manage snoring as well as sleep apnea."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The provided document does not mention any specific test set, sample size, or data provenance from a study conducted for this device. The submission relies on demonstrating substantial equivalence to predicate devices and general literature support for oral appliances.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

No test set is described, and therefore, no information is provided regarding experts or their qualifications for establishing ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No test set is described, and therefore, no information on adjudication methods is provided.

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 MRMC study was conducted or reported in this 510(k) submission. This is not an AI-assisted device.

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

No standalone algorithm performance study was conducted or reported. This device is a mechanical oral appliance, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

No specific ground truth type is mentioned as no dedicated study data is presented for this device's performance. The submission relies on the established safety and effectiveness of predicate devices and general scientific literature on oral appliances for snoring and sleep apnea.

8. The sample size for the training set

No training set is described, as this is a mechanical device submission and not an AI/algorithm submission.

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

No training set is described, and therefore, no information on how ground truth was established for a training set is provided.

Summary

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Kozouyo

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OASYS-ORAL AIRWAY SYSTEM

Mark Abramson 35 Renato Court Redwood City, CA 94061

Non-Confidential Summary of Safety and Effectiveness

Page 1 of 3

April 16, 2003

Mark Abramson 35 Renato Court Redwood City, CA 94061 Tel-(650) 369-9227

Fax-(650) 369-9241

Official Contact: Proprietary or Trade Name: Common/Usual Name: Device: Predicate Devices:

Mark Abramson, D.D.S. OASYS -Oral Airway System Oral Appliance - anti-snoring device OASYS -Oral Airway System Dr. Keith Thorton - K972061 Snore-Ezzer, LLC - K963063 Marketing Technologies, Inc. - K963616 Nellcor Puritan Bennett, Inc. - K962516

Device Description:

The OASYS ORAL AIRWAY SYSTEM Anti-Snoring Device is composed of:

Lower tray fitted over the lower teeth. ●
Upper shield fitting in front of upper anterior teeth. .
Upper molded splint fitted over upper teeth. ●
Connecting mechanism joining upper shield and lower tray. .
Extensions off shield which act as nasal dilators .

Intended Use:

Indicated use:	The OASYS Oral Airway System is intended to reduce or alleviate snoring and obstructive sleep apnea, OSA.
----------------	-----------------------------------------------------------------------------------------------------------

Target population: Adult patients.

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Non-Confidential Summary of Safety and Effectiveness (continued) Page 2 of 3 April 16, 2003

Environment of Use: Home and sleep laboratories

Comparison to Predicate Devices:

Attribute	OASYSK030440	Breathe EZK022891	Dr. 's MouthpieceK991948	Marketing T.I.K963063
Use:
Intended as anintraoral device	Yes	Yes	Yes	Yes
Intended to reduce orhelp snoring	Yes	Yes	Yes	Yes
Indicated for use withpersons who snore	Yes	Yes	Yes	Yes
Indicated for singlepatientMulti-use	Yes	Yes	Yes	Yes
Indicated for use athome or sleeplaboratories	Yes	Yes	Yes	Yes
Design:
Heat sensitiveimpressible materialfor fitting to teeth	Yes	Yes	Yes	Yes
Custom fit for eachuser	Yes	Yes	Yes	Yes
Can be adjusted orRefit	Yes	Yes	Yes	Yes
Placed in users moutheach evening	Yes	Yes	Yes	Yes
Cleaned daily	Yes	Yes	Yes	Yes
Easily removed fromMouthPermits user to breathThrough mouth	Yes	Yes	Yes	Yes
Attribute	OASYS	Breathe EZ	Dr. 's MouthpieceK991948	Marketing T.I.K963063
Prevents grinding ofTeeth	Yes	Yes	Yes	Yes
Materials:
Heat sensitiveImpression material	Yes	Yes	Yes	Yes
Rigid tray	Yes	Yes	Yes	Yes
Non-Sterile	Yes	Yes	Yes	Yes

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Non-Confidential Summary of Safety and Effectiveness (continued) Page 3 of 3 April 16, 2003

Difference Between Other Legally Marketed Predicated Devices

The difference between the intended device and predicates is only the design of the device. All of the predicates act as mandibular repositioners. The OASYS has extensions which act as nasal dilators. This difference does not have a significant effect on the safety or effectiveness of the device.

Literature supports the historical significance of oral devices that reposition the mandible and reduce and manage snoring as well as sleep apnea.

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with healthcare. The caduceus has a staff with two snakes winding around it and a pair of wings at the top.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 6 2003

Dr. Mark Abramson Mark Abramson, D.D.S. Incorporated 35 Renato Court Redwood City, California 94061

Re: K030440

Trade/Device Name: Oasys Oral Airway System Regulation Number: 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK, LWF Dated: July 8, 2003 Received: July 8, 2003

Dear Dr. Abramson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Dr. Abramson

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runner

Susan Runner, DDS, MA Interim 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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Page 1 of 1

510(k) Number (if known): __ K030440

OASYS Oral Airway System Device Name: __

Indications For Use:

OASYS Oral Airway System is intended for use to reduce or eleviate snoring and obstructive sleep apnea.

Susan Runne

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: KG38446

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use ----

(Cpuoral Format 1-2-96)

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.”