The use of the SNOREX device is indicated for anyone who snores, has a desire to alleviate or eliminate snoring, and has sufficient natural upper and lower teeth to hold the appliance in place while sleeping.

Device Description

The SNOREX is a custom formed mandibular splint designed to hold the lower jaw in a forward position while sleeping.

AI/ML Overview

The provided 510(k) summary for the SNOREX device does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria in the requested format. The document is a 510(k) premarket notification for a medical device submitted in 1997, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance study results against predefined acceptance criteria.

Here's why the requested information cannot be extracted from the given text:

No Acceptance Criteria or Performance Data: The document states that "The SNOREX and the SILENCER are comparable in all aspects." This is a general statement of equivalency, not a presentation of specific acceptance criteria (e.g., reduction in AHI by X%, snoring loudness reduction by Y dB) or quantitative performance data (e.g., actual reduction in snoring instances, AHI improvement).
No Study Details: There is no mention of a specific study design, methodology, sample size, or results of any clinical trial or performance evaluation. The document focuses on the device's description, intended use, and comparison to a predicate device.
No Ground Truth Information: Since no performance study is described, there's no mention of how ground truth was established, the number or qualifications of experts, or adjudication methods.
No MRMC or Standalone Study Information: The concepts of multi-reader multi-case studies or standalone algorithm performance are not relevant to this type of device (a physical anti-snoring appliance) and are not mentioned.
No Training Data Information: The document is about a physical device, not an AI/algorithm, so there is no training data or how its ground truth was established.

In summary, the provided document is a regulatory submission for substantial equivalence based on technological characteristics and intended use, not a performance study report. Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details.

However, based on the information provided, I can infer the general approach to regulatory clearance at the time:

Acceptance Criteria (Implied): The implied acceptance criterion is "substantial equivalence" to the predicate device, "THE SILENCER APPLIANCE," meaning it performs similarly in its intended use of maintaining open airways to reduce or eliminate snoring and sleep apnea.
"Study" (Implied): The "study" is the comparison of technological characteristics to show that the SNOREX is "comparable in all aspects" to the predicate, with the exception of the "Halstrom Hinge," which the SNOREX achieves via its "manufacturing procedure without the use of a hinge." This is a technical comparison for substantial equivalence, not a clinical trial.

Without a detailed clinical or performance study report, the requested table and specific questions cannot be answered.

Summary

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K971818

510(k) SUMMARY DEC 18 1997

Submitted by:

Vernon Pribble 8210 Carrleigh Parkway Springfield, VA 22152

Phone/Fax (703) 866 0694

Contact Person:

Vernon Pribble (see above)

Prepared:

6 May 1997

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Trade Name:

SNOREX

Common Name:

AntiSnoring Device

Classification Name:

AntiSnoring Device

Predicate Device

The SNOREX is claiming significant equivilence to

THE SILENCER APPLIANCE

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Photo and Description of SNOREX

The SNOREX is a custom formed mandibular splint designed to hold the lower jaw in a forward position while sleeping.

Image /page/2/Picture/2 description: The image shows two bone fragments against a black background. The bone fragments appear to be parts of a jawbone, with visible teeth sockets. The fragments are illuminated, making them stand out against the dark background. The image is in black and white.

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Intended Use of the Device

To maintain open airways and thereby reduce or eliminate snoring and sleep apnea.

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Summary of Technological Characteristics of SNOREX

Compared To

The Silencer Appliance

The SNOREX and the SILENCER are comparable in all aspects with the exception of the "Halstrom Hinge". The amount of advancement of the mandible and precision alignment is achieved by the SNOREX manufacturing procedure without the use of a hinge.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Vernon Pribble Owner/Operator Snorex (NZ) Ltd. 12 Kura Place, Torbay North Shore City, New Zealand

DEC 18 1997

K971818 Re : Trade Name: Snorex Requlatory Class: Unclassified Product Code: LQZ Dated: October 4, 1997 Received: October 10, 1997

Dear Mr. Pribble:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Pribble

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.ffla.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

SNOREX Device Name:

Indications for Use:

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

Concurrence of DCRHL, Office of Device Evaluation (ODE)

	Swner Runner
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K971818

Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use
---------------------------------------	----	----------------------

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.”