(438 days)
The SomnoBrux Splints are used for the protection of teeth and restorations from the forces of Bruxism.
The SomnoBrux Splints are intraoral devices used for treating bruxism. They consist of a custom fitted tray that fits over the upper or lower teeth. There are four different designs for this application all with varying degrees of function and suitability depending on the patients needs. The Michigan and the SomnBrux "B" splints are fitted on the maxillary arch and ii) The Gelb and Tanner splints are fitted on the mandibular arch. These devices function as a protective barrier between upper and lower tooth surfaces which will prevent tooth damage caused by grinding, bruxing and will help alleviate jaw and muscle pain. The dentist prescribes the Michigan, Gelb, Tanner or SomnoBrux "B" design; whichever is best suited to the patient.
The provided text is a 510(k) summary for the SomnoBrux Splints. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about specific performance acceptance criteria or a study designed to prove the device meets those criteria in the way typically found for AI/ML devices.
The entire summary focuses on establishing substantial equivalence to previously cleared devices based on comparative analysis of features, materials, and design, rather than quantitative performance metrics for the SomnoBrux Splints themselves.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not specify quantitative acceptance criteria or reported performance metrics for the SomnoBrux Splints. The conclusion of substantial equivalence is based on a qualitative comparison of design and function with predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. No test set or clinical study data is mentioned in relation to proving the performance of the SomnoBrux Splints. The submission relies on design and functional similarity to predicates.
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):
- Cannot be provided. No test set or ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. No test set or adjudication process is described.
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:
- Cannot be provided. The device is a physical intraoral splint, not an AI/ML algorithm. Therefore, an MRMC study related to AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Cannot be provided. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be provided. No ground truth is established for the SomnoBrux Splints' performance in the context of a study. The "ground truth" for this 510(k) is essentially the established safety and effectiveness of the predicate devices based on their design and intended use.
8. The sample size for the training set:
- Cannot be provided. This is not an AI/ML device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established:
- Cannot be provided. Not applicable to this type of device submission.
Summary of available information regarding substantial equivalence criteria (not "acceptance criteria" in the AI/ML sense):
The document states that the SomnoBrux Splints are substantially equivalent to the predicate devices (MYOHEALTH CLENCHING INHIBITOR and DSG Relaxer Splint) based on a "comparative analysis of features, materials and design."
- Key comparison points for substantial equivalence:
- All are custom manufactured.
- All are all acrylic type devices.
- All treat bruxism by relaxing the structure of the masticatory system.
- All cover posterior occlusal surfaces (with one predicate also covering maxillary six anterior teeth).
- Conclusion: "Any minor design differences between these various models do not affect safety and performance."
This indicates that the "acceptance criteria" for the 510(k) clearance was predominantly a qualitative assessment of functional and material similarity to legally marketed predicate devices, rather than quantitative performance benchmarks demonstrated through a specific study.
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DEC 1 3 2011
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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.
Contact Persons: Bradley Southworth Submitter Information: SomnoMed Inc.
Address of Contact Person: 7460 Warren Parkway, Suite 190, Frisco, TX 75034, Phone 888-447-6673
Date Summary Prepared: October 28, 2011
Device Name: Various versions of SomnoBrux
Trade Name(s): SomnoBrux Splint(s)
Classification Name: Mouthguard,Prescription
Panel: Dental; Product Code: MQC
The SomnoBrux Splints are intraoral devices used for treating bruxism. They Device Description: consist of a custom fitted tray that fits over the upper or lower teeth. There are four different designs for this application all with varying degrees of function and suitability depending on the patients needs. The Michigan and the SomnBrux "B" splints are fitted on the maxillary arch and ii) The Gelb and Tanner splints are fitted on the mandibular arch. These devices function as a protective barrier between upper and lower tooth surfaces which will prevent tooth damage caused by grinding, bruxing and will help alleviate jaw and muscle pain. The dentist prescribes the Michigan, Gelb, Tanner or SomnoBrux "B" design; whichever is best suited to the patient.
Intended Use: The SomnoBrux Splints are used for the protection of teeth and restorations from the forces of Bruxism.
Substantial Equivalence and Predicate Device Information:
| Device Name | Manufacturer | 510(k) Reference |
|---|---|---|
| MYOHEALTH CLENCHINGINHIBITOR also know as Bite Soft | MCI-MYOHEALTH SYSTEMS | K040315 |
| DSG Relaxer Splint | Dental Services Group SentageCorporation, dba. DentalServices Group. | K022627 |
Conclusion: Based upon the comparative analysis of features, materials and design the SomnoBrux Splint, Myo Health Clenching Inhibitor, and the SomnoBrux Splints are all custom manufactured, all acrylic type devices that treat bruxism by relaxing the structure of the masticatory system. All of these splints cover posterior occlusal surfaces, whereby the Myo Health Clenching Inhibitor only covers the Maxiliary six anterior teeth. By having the dental arches discluded with these acrylic splints (anterior or posterior) prevents excessive wear of the hard dental tissue caused by the parafunctional movement known as bruxism. Any minor design differences between these various models do not affect safety and performance.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002
Mr. Bradley Southworth Quality Assurance Manager SomnoMed Incorporated 7460 Warren Parkway. Suite 190 Frisco. Texas 75034
Re: K102909
Trade/Device Name: SomnoBrux Splints Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: MOC Dated: December 5, 2011 Received: December 7, 2011
Dear Mr. Southworth:
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.
DEC 1 3 2011
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Page 2 - Mr. Southworth
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use
510(k) Number (if known): K102909
Device Name: SomnoBrux Splints
Indications for Use: The SomnoBrux Splints are used for the protection of teeth and restorations from the forces of Bruxism.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruser
(Division Siom-Off) Division of A . sthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K162909
N/A