The TheraSom-CAST is used to reduce or alleviate the occurrence of snoring and/or for the treatment of mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older.

Device Description

The TheraSom-CASTTM anti-snoring device is a removable, adjustable intraoral device intended for the treatment of snoring and mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years or older. The device functions as a mandibular repositioner, which acts to improve the patient's ability to breathe without obstruction of the pharyngeal airway. The TheraSom-CAST is customized by molding to conform to the patient's dentition. Like the predicate devices, this device is comprised of an upper and lower component, each fitted over the corresponding dentition and coupled together by a locking mechanism. The locking mechanism of the TheraSom-CAST is formed by stainless steel tension springs connected to the upper and lower components externally on either side of the device. The springs may vary in lengths and may be moved to adjust the relative positions of the upper and lower components so as to set the distance of the mandibular advancement. While the device includes no plastic parts (the upper and lower components are made from dental cast alloy and the springs are formed of stainless steel); this difference in materials and the construction by customized dental cast molding do not introduce any new safety issues.

AI/ML Overview

The provided text describes a 510(k) submission for the TheraSom-CAST™ device, which is an intraoral device intended to treat snoring and mild to moderate obstructive sleep apnea (OSA). The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a formal statistically powered study.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state acceptance criteria or provide a table of performance metrics to be compared against such criteria. Instead, it relies on a "feasibility study" and a comparison of substantial equivalence characteristics to predicate devices.

The "feasibility study" reports the following:

Performance Metric	Reported Device Performance (TheraSom-CAST™)
AHI post-treatment	Measured for each patient (specific values not provided, only "measured")
Snoring	Patients reported that use of the device at night reduced the symptom of snoring.
Gingival Health	Visual screening performed after 8+ months of use (results not explicitly stated, implied to be acceptable as no adverse events mentioned).
Tooth Mobility	Physical assessment performed after 8+ months of use (results not explicitly stated, implied to be acceptable as no adverse events mentioned).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Five (5) participants.
Data Provenance: The study was a "feasibility study." The location is not explicitly stated, but the submitter is Family Dental Services, P.C. in Albuquerque, New Mexico, USA, so it's likely US-based. The study is prospective for the duration of the feasibility assessment, as participants were "assessed with polysomnographic study...with and without the device in place" and followed for "at least 8 months" after use of the device.

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

The document does not specify the number or qualifications of experts used to establish a ground truth for the test set.

Polysomnographic studies are typically interpreted by sleep physicians or trained sleep technologists.
Visual screening of gingival health and physical assessment of tooth mobility would typically be performed by a dentist or periodontist.

However, the specific number and qualifications of individuals performing these assessments are not detailed in the summary.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set data. Given the small "feasibility study" size and its nature as a preliminary assessment, a formal adjudication process is unlikely to have been detailed or performed as part of this type of submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission presents a small feasibility study and a substantial equivalence comparison to predicate devices, not a study comparing human readers with and without AI assistance, or comparing human readers generally.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The TheraSom-CAST™ is a physical intraoral device, not an algorithm or AI system. Therefore, a standalone (algorithm only) performance study is not relevant.

7. Type of Ground Truth Used

The ground truth for the feasibility study appears to be a combination of:

Objective physiological measures: AHI post-treatment from polysomnographic study.
Expert clinical assessment: Visual screening of gingival health and physical assessment of tooth mobility.
Patient-reported outcomes: Patients reported reduced snoring.

8. Sample Size for the Training Set

Not applicable. The TheraSom-CAST™ is a physical medical device, not an AI/ML algorithm that requires a training set. The device is customized to each patient through molding and adjustment by a dentist or physician.

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

Not applicable, as there is no training set for this device.

Summary

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JAN 0 4 2013

510(k) Summary

This summary of substantial equivalence for the purposes of assessing safety and effectiveness under Section 510(k) of the Federal Food, Drug, and Cosmetic Act is being submitted in accordance with the requirements of 21 CFR 807.92.

Submitter:	Family Dental Services, P.C.
Contact Person:	Thomas E. Meade, D.D.S.
	Family Dental Services, P.C.
	215 16th Street, S.W.
	Albuquerque, New Mexico 87104
	Tel: (505) 263-7172
Device Name/Trade Name:	TheraSom-CAST™
Classification Name:	Intra Oral Devices for Snoring and Intra Oral Devices for Snoring
	and Obstructive Sleep Apnea (21 CFR 872.5570)
Panel:	Dental
Classification Product Code:	LRK
Subsequent Product Code:	LQZ

Predicate Devices:

Device Trade Name	Manufacturer	510(k) ReferenceNumber	ProductCode
Myerson EMA	Frantz Design, Inc.	K971794	LRK
Adjustable PM Positioner	Jonathan A. Parker, D.D.S.	K955503	LQZ
Lowe Klearway	Dr. Alan A. Lowe, Inc.	K950763	LRK
SomnoMed MAS RXA	SomnoMed, Ltd.	K050592	LRK

Intended Use:	The TheraSom-CAST is used to reduce or alleviate the occurrenceof snoring and/or for the treatment of mild to moderate obstructivesleep apnea (OSA) in patients 18 years of age or older.
Target Population:	Adult patients who have been medically diagnosed with snoringand/or mild to moderate OSA.
Environment of Use:	The device is intended for use by patients at home and in sleeplaboratories

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Device Description:

Brief Discussion

of Feasibility Study:

A feasibility study was conducted wherein five (5) participants were assessed with polysomnographic study in a sleep center, with and without the device in place. AHI post-treatment with the device was measured for each patient. Visual screening of gingival health and physical assessment of tooth mobility were performed after use of the device for a period of time of at least 8 months. The patients reported that use of the device at night reduced the symptom of snoring.

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Substantial EquivalenceCharacteristics	TheraSom-CAST	MyersonEMA	AdjustablePMPositioner	SomnoMedMAS	LoweKlearway
Use
For intraoral use	Yes	Yes	Yes	Yes	Yes
Intended to treat snoring	Yes	Yes	Yes	Yes	Yes
Indicated for treatmentof mild to moderate OSA	Yes	Yes	Yes	Yes	Yes
Indicated for single,adult patient multi-use	Yes	Yes	Yes	Yes	Yes
Design
Molded upper and lowerpieces	Yes	Yes	Yes	Yes	Yes
Separate upper andlower componentsconnected by lockingmechanism	Yes	Yes	Yes	Yes	Yes
Side placement of buccallocking mechanisms	Yes	Yes	Yes	Yes	Yes
Metallic buccal lockingmechanisms	Yes	No	Yes	Yes	Yes
Coiled spring lockingmechanisms	Yes	No	No	No	No
Titrateable, can beadjusted or re-fit	Yes	Yes	Yes	Yes	Yes
Inserted by patient atnight	Yes	Yes	Yes	Yes	Yes
Allows for nasal/oralbreathing	Yes	Yes	Yes	Yes	Yes
Permits patient to speakor drink while installed	Yes	Yes	Yes	Yes	Yes
Materials
Upper and lower piecesconstructed from acrylicmaterial	No	Yes	Yes	Yes	Yes
Upper and lower piecesconstructed of dentalalloy material	Yes	No	No	No	No

Comparison of TheraSom-CASTTM to Predicate Devices

・

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Substantial Equivalence Discussion

The TheraSom-CAST™ is believed to be substantially equivalent to the referenced predicate devices. The TheraSom-CAST and the predicate devices function as mandibular repositioners which displace the patient's mandible during sleep. The mechanical components of the . TheraSom-CAST and the predicate devices are similar, i.e. they include an upper and lower appliance component and a locking mechanism that is designed to advance the position of the lower component in relation to the upper component, thereby advancing the mandible. As with the predicate devices, the TheraSom-CAST is customized to fit each patient, and the mandibular advancement is adjusted by the dentist or physician at the time of fitting. All the contact surfaces of the TheraSom-CAST are constructed of metal and include no plastics, however this difference does not affect the mode of operation of the device as a mandibular repositioner, and it has not introduced any new safety issues.

CONCLUSION

The construction, intended use and mode of operation of the TheraSom-CAST are substantially similar to the predicate devices, and clinical study data demonstrates that the device is substantially equivalent in effectiveness and safety to the predicate devices.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service .

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

January 4, 2013

Family Dental Services, P.C. C/O Ms. Deanna L. Baxam Baxam Law Group, Limited Liability Company 2180 Satellite Boulevard, Suite 400 DULUTH GA 30097

Re: K113516

Trade/Device Name: TheraSom-CAST™ 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, LQZ

Dated: November 20, 2012 Received: November 27, 2012

Dear Ms. Baxam:

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 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.

Kwame O. Ulmer

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use

510(k) Number: K | | 35 | (To be assigned)

ં M Device Name: TheraSom-CAST

Indications for Use: The TheraSom-CAST is used to reduce or alleviate the occurrence of snoring and/or for the treatment of mild to moderate obstructive sleep apnea (OSA) in patients 18 years of age or older.

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

Over-The-Counter Use NO (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)

2013.01.04 Susan Runner DDS, MA 07:50:13 -05'00'

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

K113516

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.”