(254 days)
AcceleDent is an orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement.
The AcceleDent™ System is an orthodontic accessory for the treatment of tooth malocclusion. AcceleDent™ should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment with fixed appliances such as braces. The Activator and Mouthpiece assembly is light (2.7 oz or 75 g), comfortable, handsfree, and can be used while multi-tasking or while engaged in a variety of other daily activities.
The AcceleDent™ System is an orthodontic accessory intended to facilitate minor anterior tooth movement when used in conjunction with orthodontic appliances like braces.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated Goal) | Device Performance (Study Results) |
|---|---|
| Increase the rate of tooth movement when used as an adjunct to conventional orthodontic treatment. | The study demonstrated that the AcceleDent™ increased the rate of tooth movement when used as an adjunct to conventional orthodontic treatment. |
| No significant safety risks. | The study demonstrated that the AcceleDent™ increased the rate of tooth movement... without any significant risks, including evaluation of root resorption. |
2. Sample Size and Data Provenance:
- Test set sample size: Not explicitly stated in the provided text. The text mentions "Patients were followed at regular intervals," implying a clinical study with human subjects.
- Data provenance: Prospective clinical study ("A clinical study was performed to support this 510(k) Notification"). The country of origin is not specified, but the submission is to the U.S. FDA, suggesting the study was likely conducted or overseen in a region compliant with their regulations.
3. Number and Qualifications of Experts for Ground Truth:
- Not applicable/Not explicitly stated for the primary outcome. The study directly measured "rate of tooth movement" by following patients at regular intervals until "closure was achieved." This is an objective, measurable outcome.
- For safety assessments, "evaluation of root resorption" would typically involve dental professionals (e.g., orthodontists, radiologists), but the number and specific qualifications of these experts are not provided.
4. Adjudication Method for the Test Set:
- Not explicitly stated. Given the objective nature of measuring tooth movement and root resorption, it's possible that direct measurements were taken, and consensus or multiple readings might not have been a primary concern for the direct outcome measures.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described.
- The study compared "standard orthodontics plus the AcceleDent™ device" to "standard orthodontics plus a sham control," indicating a comparative clinical trial, but not necessarily focused on human reader performance with or without AI assistance. This device is not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance:
- No, a standalone (algorithm only) performance study was not described. The device is a physical orthodontic accessory for direct patient use, not a diagnostic algorithm.
7. Type of Ground Truth Used:
- Objective Clinical Measurements:
- Rate of tooth movement: Measured directly by following patients at regular intervals until closure was achieved.
- Root resorption: Evaluated as a safety assessment.
8. Sample Size for the Training Set:
- Not applicable/Not stated. This device is a physical medical device, not an AI model that requires a training set.
9. How Ground Truth for Training Set was Established:
- Not applicable. The device is a physical medical device, not an AI model.
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)))OrthoAccel
Technologies, Inc
AcceleDent " System TRADITIONAL 510(k) NOTIFICATION
510(k) Summary-
AcceleDent™ System
November 15, 2011
This summary of 510(k) substantial equivalence determination is being submitted in accordance with the requirements of 21 CFR part 807.92.
| Submitter: | OrthoAccel® Technologies, Inc.8275 El Rio Street, Suite 100Houston, TX 77054Phone: 832-631-1657Fax: 713-583-9972 |
|---|---|
| ------------ | ---------------------------------------------------------------------------------------------------------------------------------- |
Contact: Michael E Kaufman
| Device trade name: | AcceleDent™ System |
|---|---|
| Common name: | Orthodontic appliance and accessories |
| Classification name: | Orthodontic Vibratory Accessory |
| Classification: | Class II |
| Panel: | Dental |
| Product code: | OYH |
| Regulation number: | 872.5470 |
| Predicate device: | The Orthotrainer, K924975 |
Device Description:
The AcceleDent™ System is an orthodontic accessory for the treatment of tooth malocclusion. AcceleDent™ should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment with fixed appliances such as braces. The Activator and Mouthpiece assembly is light (2.7 oz or 75 g), comfortable, handsfree, and can be used while multi-tasking or while engaged in a variety of other daily activities. The most commonly reported multi-tasking use by patients was watching television, reading, using the computer, listening to music and doing homework.
510(k) Section 005 Page 1
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OrthoAccel"
technologies, Inc.
AcceleDent™ System TRADITIONAL 510(k) NOTIFICATION
Intended Use:
AcceleDent™ is an orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement.
Characteristics Comparison:
A comparison of the AcceleDent™ System's indications for use with the predicate device indicates the AcceleDent™ System is substantially equivalent to currently marketed devices according to the following comparison:
- The general intended use of the device as an adjunct to orthodontics to facilitate ● tooth movement is the same as the OrthoTrainer.
- The indications for use to accelerate tooth movement during standard ● orthodontic treatment is a subset of the broader indications of the OrthoTrainer.
- The technological characteristics of the AcceleDent™ are very similar to the . OrthoTrainer. Both are elastomeric devices that are held in the mouth for a sustained period each day.
Performance Testing:
Non-clinical and clinical performance testing completed with the AcceleDent™ System has demonstrated that the device performs safely and as intended.
Non-clinical performance testing completed:
- Output force testing .
- Force testing .
- Electromagnetic Compatibility and Electrical Safety .
- . Biocompatibility
A clinical study was performed to support this 510(k) Notification. The study was performed to determine whether teeth moved faster with standard orthodontics plus the AcceleDent™ device when compared to standard orthodontics plus a sham control.
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OrthoAccel®
Technologies, Inc.
AcceleDent™ System TRADITIONAL 510(k) NOTIFICATION
Patients were followed at regular intervals to measure the rate of tooth movement until closure was achieved. Safety assessments also included evaluation of root resorption. The results of the study demonstrated that the AcceleDent™ increased the rate of tooth movement when used as an adjunct to conventional orthodontic treatment, and without any significant risks.
Conclusion:
Based on the results of non-clinical and clinical testing, the AcceleDent™ System performs safely, as intended, and is substantially equivalent to the predicate device.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion. The text is in all caps and is relatively small compared to the caduceus symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Michael E. Kaufman Vice President Marketing & Business Development OrthoAccel Technologies, Incorporated 8275 El Rio, Suite 100 Houston, Texas 77054
NOV 1 7 2011
Re: K110661
Trade/Device Name: AcceleDent" System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: OYH Dated: November 9, 2011 Received: November 10, 2011
Dear Mr. Kaufman:
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 – Mr. Kaufman
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 10 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,
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
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Indication for Use
K110661 510(k) Number (if known):
Device Name:
AcceleDent™ System
Indication For Use:
AcceleDent is an orthodontic accessory intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use __ (21 CFR Part 801 Subpart C)
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Concurrence of CDRH, Office Device Evaluation (ODE)
Division Sign-Off
510(k)__
Seser Rnom
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110661
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.