(212 days)
BRUX MOUTHGUARDS are indicated to help protect the teeth from damage caused by bruxism, sports injuries, and muscle contractions.
BRUX MOUTHGUARDS are polymer trays that are used intraorally over the dentition. Two models are to be offered for upper (BRUX NIGHT), or lower (BRUX SPORT) dentition.
The provided text describes a 510(k) summary for BRUX MOUTHGUARDS. This submission primarily focuses on establishing substantial equivalence to a predicate device and includes biocompatibility testing. It does not contain information typically associated with studies proving acceptance criteria for AI/ML-powered medical devices, such as performance metrics (sensitivity, specificity, AUC), sample sizes for test sets, expert-derived ground truth, or comparative effectiveness studies.
Therefore, many of the requested fields cannot be answered from the provided text.
Here's a breakdown of what can be answered based on the given information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-cytotoxic | Non-cytotoxic |
| Non-oral irritant | Non-oral irritant |
| Non-skin sensitizer | Non-skin sensitizer |
Explanation: The acceptance criteria for BRUX MOUTHGUARDS, as implied by the testing performed, focused on biocompatibility. The reported performance confirmed that the material met these criteria.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. The "test set" in this context refers to the biological samples used for biocompatibility testing, not a dataset for an algorithm. The specific number of samples for cytotoxicity, oral irritation, and skin sensitization tests is not provided.
- Data Provenance: Not specified, but these are standard in-vitro and in-vivo (animal) biocompatibility tests conducted according to ISO 10993 guidelines.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Biocompatibility testing results are typically interpreted by laboratory personnel and toxicologists/biocompatibility specialists, not "experts" in the sense of clinical reviewers establishing ground truth for an AI algorithm.
- Qualifications of Experts: Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Biocompatibility test results are typically determined by established laboratory protocols and readings, not by an adjudication process as understood in clinical studies for algorithm evaluation.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a physical mouthguard, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: No, a standalone algorithm performance study was not done. This device is a physical mouthguard.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" here is the biological response observed in biocompatibility tests (e.g., cell viability for cytotoxicity, tissue reaction for irritation).
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable.
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510(k) Summary
CONTACT: Massimo Sasso, President DENTAL ARTE, INC. 13670 Danielson St. Suite F Poway, CA 92064 USA Ph:(858) 486-5484 Fax:(858) 486-7674 massimo.sasso@dentalarteinc.com www.dentalarteinc.com
DATE PREPARED: October 18, 2011 TRADE OR PROPRIETARY NAME: BRUX MOUTHGUARDS CLASSIFICATION NAME: MOUTHGUARDS PREDICATE DEVICE: K073446
This summary includes only information that is also covered in the body of this 510(k) document, does not contain any puffery or unsubstantiated labeling claims, does not contain any raw data, i.e., contains only summary data, and does not contain any patient identification information. Confidential information is included.
DEVICE DESCRIPTION: BRUX MOUTHGUARDS are polymer trays that are used intraorally over the dentition. Two models are to be offered for upper (BRUX NIGHT), or lower (BRUX SPORT) dentition.
INTENDED USE: BRUX MOUTHGUARDS are indicated to help protect the teeth from damage caused by bruxism, sports injuries, and muscle contractions.
TECHNOLOGICAL CHARACTERISTICS vs. the predicate device: BRUX MOUTHGUARDS are essentially identical to the predicate device, Archtek Inc. Grind Guard (K073446).
Both BRUX MOUTHGUARDS (BRUX NIGHT and BRUX SPORT) and the predicate mouthguards are composed of EVA and designed for use over the dentition for protection from biting forces.
BRUX MOUTHGUARDS are available in limited colors.
OTHER: The BRUX MOUTHGUARD material was tested according to ISO 10991-1 guidelines for cytotoxicity (ISO 10993-5), oral irritation (ISO 10993-10) and skin sensitization (ISO 10993-10). The results of this testing show that the material of the BRUX MOUTHGUARDS was non-cytotoxic, and was neither an oral irritant, nor a skin sensitizer.
We believe that the performance data provided herein support the safety and effectiveness of use of BRUX MOUTHGUARDS.
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized symbol with three curved lines above a wavy line, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
DEC - 8 2011
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dental Arte, Incorporated C/O Ms. Carolyn M. Primus Consultant Primus Consulting 7046 Owl's Nest Terrace Braderdon, Florida 34203
Re: K111310
Trade/Device Name: BRUX MOUTHGUARDS Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: OBR, MQR Dated: October 18, 2011 Received: October 28, 2011
Dear Ms. Primus:
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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Page 2 - Ms. Primus
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 /ucm 115809.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 yours.
hh 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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510(k) Number (if known):K111310
Device Name: BRUX MOUTHGUARDS
Indications For Use: BRUX MOUTHGUARDS are indicated to help protect the teeth from damage caused by bruxism, sports injuries, and muscle contractions.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (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), ANTYBE Page 1 of
Premarket Notification K11031
Dental Arte Inc. BRUX MOUTHGUARDS
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Digital, Devices
510(k) Number:
N/A