The Somnomed MAS Flex "S" is an intra-oral device used for treating Snoring and mild to moderate Obstructive Sleep Apnea. It consists of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable lugs. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep and improves their ability to exchange air during sleep. The device is custom made for each patient and has the adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the SomnoMed MAS Flex "S" device. It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria in the typical sense for algorithm performance.

Here's an analysis based on the information provided and how it relates to your request:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or detailed performance metrics in the way one would for a diagnostic algorithm. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to existing predicate devices.

Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (Summary of Comparison)
Indications for Use:	Indications for Use:
- Treatment of Snoring in Adults	- Yes (Matches all predicate devices)
- Treatment of mild to moderate Obstructive Sleep Apnea	- Yes (Matches all predicate devices)
Operational Use:	Operational Use:
- Intra oral device for overnight use	- Yes (Matches all predicate devices)
- Single patient multi use	- Yes (Matches all predicate devices)
- Use at home or at a Sleep Laboratory	- Yes (Matches all predicate devices)
- Prescription Device	- Yes (Matches all predicate devices)
Action Mechanism:	Action Mechanism:
- Works by mandibular advancement	- Yes (Matches all predicate devices)
Design Characteristics:	Design Characteristics:
- Custom fit for each patient	- Yes (Matches all predicate devices)
- Rigid separate upper and lower tray pieces	- Yes (Matches all predicate devices)
- Can be adjusted or refit	- Yes (Matches all predicate devices)
- Lower jaw adjustment using a supplied adjustment key	- Yes (Matches all predicate devices)
- Cleaned and inspected daily	- Yes (Matches all predicate devices)
- Permits patient to breathe through the mouth	- Yes (Matches all predicate devices)
- Upper and lower trays disengage for easy removal from mouth	- Yes (Matches all predicate devices)
Materials:	Materials:
- Safe and effective for intended use	- Trays constructed from a soft lining material adhered to a hard surface acrylic. This is the primary difference from the original SomnoMed MAS, but the document states "This difference does not have significant effect on the safety or effectiveness of the SomnoMed MAS Flex "S"." Bench testing confirmed material biocompatibility and product strength.

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

There is no test set sample size mentioned as this document does not describe a clinical study comparing the device's efficacy in a patient population against a gold standard for snoring or sleep apnea reduction. The submission is focused on material changes and confirming safety/equivalence through bench testing.

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)

Not applicable. There was no human expert evaluation of a test set for clinical performance mentioned. The ground truth, in the context of a 510(k) for a modified device, is primarily the established safety and effectiveness of the predicate device for its intended use, and the demonstration that the material change does not negatively impact this.

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

Not applicable. There was no test set requiring expert adjudication.

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

Not applicable. This device is a physical medical device (intra-oral appliance), not an AI algorithm, and therefore an MRMC study is not relevant to its evaluation.

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

Not applicable. This is a physical device, not an algorithm.

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

The "ground truth" in this context is the established safety and effectiveness of the predicate device (SomnoMed MAS K020592) for treating snoring and mild to moderate obstructive sleep apnea, combined with bench testing data (biocompatibility, product strength) on the new material to demonstrate it does not compromise these aspects.

8. The sample size for the training set

Not applicable. This is a physical device and does not involve a training set for an algorithm.

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

Not applicable. This is a physical device and does not involve a training set for an algorithm.

In summary:

This 510(k) notification is for a modification to an existing physical medical device, primarily involving a change in catch material. The "study" referenced is bench testing to confirm the new material's biocompatibility and product strength, and a comparison table to demonstrate that the new device retains all functional attributes and indications for use of the predicate device. The primary "proof" is the demonstration of substantial equivalence to an already legally marketed device, not a new clinical efficacy trial for the device's therapeutic effect.

Summary

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Premarket Notification - SomnoMed MAS Flex "S"

K073004

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

Submitter Information: SomnoMed Inc

JAN 30 Ok

Date Summary Prepared: 5th October 2007

Contact Persons: Ashley Truitt

Device Name: Trade Name(s): SomnoMed MAS Flex "S" Classification Name: Device, Anti-snoring (21CFR827.5570) Panel: Dental Product Code: LRK

Predicate Device Information:

Device Name------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	Manufacturer	510(k) Reference
SomnoMed MAS	SomnoMed Inc	K020592

Device Description:

Intended use - The SomnoMed MAS Flex "S" is intended to reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea.

Target population – Adult patients who have a problem with snoring or obstructive sleep apnea.

Environment of Use – The device is initially fitted under the supervision of a licensed practitioner (dentist or physician) and is subsequently used in either a home environment or in a sleep laboratory.

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Comparison to Predicate Device:

K073002
2 of 3

This submission is for a modification to the originally cleared SomnoMed MAS device.

The SomnoMed MAS Flex "S" is substantially equivalent to the SomnoMed MAS with the only exception of a soft lining material (SMH Flex "S") that can be used instead of the stainless steel ball clasps for retention. The difference between the two types of retention are that the soft lining material (SMH Flex "S") is technologically advanced to grip around the tooth creating a good retention which is designed for patient comfort, this negates the need for metal retention such as ball clasps.

	SomnoMedMASK050592	OASYSK030407	TAP 11K062951	SomnoMedFlex 292
Indications for Use
Treatment of Snoring in Adults	yes	yes	yes	Yes
Treatment of mild to moderate obstructive sleep apnea	yes	yes	yes	yes
Use
Intra oral device for overnight use	yes	yes	yes	yes
Single patient multi use	yes	yes	yes	yes
Use at home or at a Sleep Laboratory	yes	yes	yes	yes
Prescription Device	yes	yes	yes	yes
Action
Works by mandibular advancement	yes	yes	yes	yes
Design
Custom fit for each patient	yes	yes	yes	yes
Rigid separate upper and lower tray pieces	yes	yes	yes	yes
Can be adjusted or refit	yes	yes	yes	yes
Lower jaw adjustment using a supplied adjustment key	yes	yes	yes	yes
Cleaned and inspected daily	yes	yes	yes	yes
Permits patient to breathe through the mouth	yes	yes	yes	yes
Upper and lower trays disengage for easy removal from mouth	yes	yes	yes	yes
Materials
Trays constructed from molded hard acrylic and ball clasps	yes	no	no	no
Trays constructed from a soft lining material adhered to a hardsurface acrylic	no	no	no	yes
Trays constructed from a heat sensitive impress able material forfitting to teeth	no	yes	yes	no

The difference between the intended device SomnoMed Flex "S" and the predicate devices are the materials. All of the predicates act as mandibular repositioners for the treatment of Snoring and mild to moderate Obstructive Sleep Apnea. This difference does not have significant effect on the safety or effectiveness of the SomnoMed MAS Flex "S". It is the prescribing physician's choice what material is used for the patients comfort and what is most suitable for the individual patient's dentition.

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K673004
373

Comparative performance testing was carried out with a previously cleared predicate material Ivocap Elastomer K896130 that is used in the Orthodontic field for the fabrication of Tooth Positioners, Mouthguards and Soft Bite Guards.

Performance Test Data and Conclusions:

Bench testing has established material biocompatibility and product strength with the material SMH Flex "S".

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human figures within its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 30 2008

Ms. Ashley Truitt SomnoMed Incorporated 3537 Teasley Lane Denton, Texas 76210

Re: K073004

Trade/Device Name: SomnoMed MAS Flex "S" 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, EBI Dated: December 15, 2007

Dear Ms. Truitt:

Received: January 25, 2008

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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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 (OS) 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 vour 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Suita y. Michioms

Chiú Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

K073004

1081

510(k) Number (if known):

Device Name: SomnoMed MAS Flex "S"

Indications for Use:

The SomnoMed MAS Flex "S" is intended to reduce or alleviate night time Snoring and mild to moderate Obstructive Sleep Apnea (OSA).

Prescription Use	XX
(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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)
Division of Anesthesiology, General HospitalInfection Control, Dental Devices
510(k) Number:	K073004

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.”