AcceleDent® Aura is intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement.

Device Description

AcceleDent® Aura is an orthodontic accessory for the treatment of tooth malocclusion. It is used as an adjunctive therapy for patients with orthodontic appliances such as braces to help facilitate tooth movement. AcceleDent® Aura should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment.

AcceleDent® Aura includes the Activator, Mouthpiece and Travel Case. The Activator and connected Mouthpiece are used by patients to provide a light vibration to the teeth – the Activator vibrates at a 0.25 N (25 grams) force level and 30 Hz frequency for 20 minutes when turned-on; the vibration is transmitted from the Activator through the Mouthpiece to the patient's teeth as they lightly bite down on the Mouthpiece.

The Activator and Mouthpiece assembly is light, comfortable, hands-free, and can be used while multi-tasking or while engaged in a variety of other daily activities. The Travel Case is an enclosure that may be used to conceal, protect, and keep the AcceleDent® Aura Activator and Mouthpiece clean while not in use. The device includes a USB port, which can connect directly into a computer or power supply to recharge the battery. The USB port can also be connected to a computer to display usage data. A USB Cable and Power Adaptor are included to complete the system.

AI/ML Overview

The provided document is a 510(k) premarket notification for the AcceleDent Aura, an orthodontic accessory. It explicitly states: "No further clinical data were collected for AcceleDent® Aura." This means there isn't a new study demonstrating the device meets acceptance criteria as typically understood for new medical devices requiring clinical trials.

Instead, the submission relies on the concept of substantial equivalence to a previously cleared predicate device (AcceleDent, K110661). The acceptance criteria and "proof" in this context refer to engineering and performance testing comparing the new device (AcceleDent Aura) to the predicate device to ensure it performs safely and as intended, without significant differences in safety or effectiveness.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly that the AcceleDent Aura performs functionally equivalently to the predicate AcceleDent, particularly regarding the therapeutic vibration parameters and intended use. The performance data presented is primarily a comparison table that shows identical specifications for the core therapeutic elements.

Feature / Acceptance Criteria	Predicate Device (AcceleDent) Performance	Subject Device (AcceleDent Aura) Performance	Note/Acceptance
Intended Use (facilitate minor anterior tooth movement)	Yes	Yes	Identical. Acceptance: Considered substantially equivalent for this critical aspect.
Regulation Number (21 CFR 872.5470)	21 CFR 872.5470	21 CFR 872.5470	Identical. Acceptance: Complies with same regulatory classification.
Product Code (OYH)	OYH	OYH	Identical. Acceptance: Same product code.
Device Class (II)	II	II	Identical. Acceptance: Same device class.
For use with orthodontics	Yes	Yes	Identical. Acceptance: As intended.
Material (Elastomer)	Elastomer	Elastomer	Identical. Acceptance: No change in material for key components.
Duration of Use (20 minutes per day)	20 minutes per day	20 minutes per day	Identical. Acceptance: Same treatment protocol.
Power Source (Lithium Polymer Battery)	Lithium Polymer Battery	Lithium Polymer Battery	Identical. Acceptance: Same battery type.
Output Force (0.25 N / 25 g)	0.25 N (25 g)	0.25 N (25 g)	Identical. Acceptance: This is a critical therapeutic parameter. Maintaining the same output force ensures similar biological effect.
Frequency (30 Hz)	30 Hz	30 Hz	Identical. Acceptance: This is another critical therapeutic parameter. Maintaining the same frequency ensures similar biological effect.
Weight - Activator (grams)	65 g	33 g	Difference. New device is lighter. Acceptance: Improved user experience, not expected to negatively impact safety or effectiveness, potentially enhances compliance.
Dimensions - Activator (HxLxW -mm)	76x41x28	79x36x30	Difference. Slight dimensional changes. Acceptance: Not expected to impact therapy, likely related to reduced weight/design improvements.
Rechargeable	Yes	Yes	Identical. Acceptance: Functionality maintained.
Automatic Timer	Yes	Yes	Identical. Acceptance: Functionality maintained.
Usage Data	Yes - Displayed on charging port	Yes - Displayed on PC (FastTrac Usage Report)	Difference. Method of displaying usage data changed. Acceptance: Functionality maintained, with an update to data access method (PC connection via USB). This is an enhancement, not a compromise.
Activator/Mouthpiece Attachments	Yes / Same	Yes / Same	Identical. Acceptance: Core components are present and compatible.
USB Connector	No	Yes	Difference. New feature. Acceptance: Enhancement for charging and data transfer, not affecting core therapeutic function negatively.
Charging Port	Yes	No	Difference (replaced by USB). Acceptance: Charging mechanism altered but charging functionality maintained via USB.
Travel Shell/Case	Yes (Shell)	Yes (Case)	Difference. Storage accessory name/design changed. Acceptance: Device still protected for travel.
Audible On/Off Switch	No	Yes	Difference. New feature. Acceptance: Enhancement for user feedback, not affecting core therapeutic function negatively.
Shelf Life	2.0 years	2.0 years	Identical. Acceptance: Device stability maintained.
Battery Life	2.5 years	2.0 years*	Difference. Slightly reduced stated battery life (2.0 years vs 2.5 years, with deactivation after 18 months of daily use). Acceptance: The battery life is still sufficient for the intended treatment duration and designed to deactivate after accumulated usage, indicating a controlled obsolescence rather than a deficiency. This is disclosed and deemed acceptable.

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

Sample Size: Not applicable in the context of clinical testing for this 510(k) submission. The changes were evaluated through design control review, risk analysis (ISO 14971), and verification testing (IEC 60601 and device specifications), rather than a sample of patient data.
Data Provenance: Not applicable for clinical data. The engineering and performance testing would have been conducted by the manufacturer, OrthoAccel Technologies, Inc., based in Bellaire, TX, USA. These are laboratory/bench tests, not patient-derived data.
Retrospective/Prospective: Not applicable.

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 as there was no clinical test set for which ground truth needed to be established by experts. The "ground truth" for this 510(k) is the performance of the predicate device.

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

Not applicable as there was no clinical test set requiring 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 an orthodontic vibrating accessory, not an AI-assisted diagnostic tool for human readers.

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

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

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

For this 510(k), the "ground truth" for performance is the established safety and effectiveness of the predicate device (AcceleDent, K110661), which was presumably demonstrated through its own testing and clinical data at the time of its 510(k) clearance. The AcceleDent Aura is deemed substantially equivalent because its modifications do not alter its fundamental scientific technology, intended use, or therapeutic parameters (output force, frequency).

8. The sample size for the training set

Not applicable, as no clinical training set was used for this 510(k) submission for the AcceleDent Aura device.

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

Not applicable, as no clinical training set was used.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for OrthoAccel Technologies, Inc. The logo features the company name in a bold, sans-serif font, with three curved lines above the "O" in "OrthoAccel", which may represent radio waves. Below the company name, in a smaller font, is the company's legal designation, "Technologies, Inc.". The logo is simple and modern, and it is likely used on the company's website, marketing materials, and products.

AcceleDent Aura Special 510(k) NOTIFICATION

APR 2 3 2013

510(k) Summary

· AcceleDent® Aura

April 11, 2013

This summary of Special 510(k) substantial equivalence determination is being submitted in accordance with the requirements of 21 CFR part 807.92.

510(k) Submitter:	OrthoAccel® Technologies, Inc.6575 West Loop South, Suite 200Bellaire, TX 77401Phone: 832-803-0339Fax: 713-583-9972
Contact:	Zaffer Syed
Device trade name:	AcceleDent® Aura
Common name:	Orthodontic plastic bracket
Classification name:	Orthodontic Vibratory Accessory
Regulation number:	21 CFR 872.5470
Classification:	Class II
Panel:	Dental
Product code:	OYH
Predicate Device:	AcceleDent®, 510(k) Number K110661

Device Description:

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Image /page/1/Picture/0 description: The image shows the logo for OrthoAccel Technologies, Inc. Below the logo is the text "AcceleDent Aura TM" and "Special 510(k) NOTIFICATION". The text is black and the background is white.

conceal, protect, and keep the AcceleDent® Aura Activator and Mouthpiece clean while not in use. The device includes a USB port, which can connect directly into a computer or power supply to recharge the battery. The USB port can also be connected to a computer to display usage data. A USB Cable and Power Adaptor are included to complete the system.

AcceleDent® Aura is a modified version of the predicate FDA-cleared AcceleDent® [[510(k) Number K110661]. The fundamental scientific technology of delivering therapeutic vibrations to teeth and the intended use have not changed with the subject AcceleDent® Aura device. A comparison table of the AcceleDent® Aura to the predicate AcceleDent® is shown below.

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Image /page/2/Picture/0 description: The image shows the logo for OrthoAccel Technologies, Inc. The logo features a stylized symbol resembling sound waves emanating from the letter 'O', followed by the text "OrthoAccel" in a bold, sans-serif font. Below "OrthoAccel" is the text "technologies, inc." in a smaller, lighter font.

AcceleDent Aura™ Special 510(k) NOTIFICATION

Comparison of AcceleDent® and AcceleDent® Aura

	AcceleDent® (Predicate Device)	AcceleDent® Aura (Subject Device)
Indication for Use	AcceleDent® is an orthodonticaccessory intended for use duringorthodontic treatment. It is used inconjunction with orthodonticappliances such as braces andhelps facilitate minor anteriortooth movement.	AcceleDent® Aura is an orthodonticaccessory intended for use duringorthodontic treatment. It is used inconjunction with orthodonticappliances such as braces andhelps facilitate minor anteriortooth movement.
Regulation Number	21 CFR 872.5470	21 CFR 872.5470
Product Code	ΟΥΗ	ΟΥΗ
Device Class	II	II
510(k) Number	K110661	K130643
For use with orthodontics	Yes	Yes
Material	Elastomer	Elastomer
Duration of Use	20 minutes per day duringOrthodontic treatment	20 minutes per day duringOrthodontic treatment
Power Source	Lithium Polymer Battery	Lithium Polymer Battery
Output Force	0.25 N (25 g)	0.25 N (25 g)
Frequency	30 Hz	30 Hz
Weight - Activator (grams)	65	33
Dimensions - Activator(HxLxW -mm-)	76x41x28	79x36x30
Rechargeable	Yes	Yes
Automatic Timer	Yes	Yes
Usage Data	Yes - Displayed on charging port	Yes - Displayed on PC(FastTrac Usage Report)
Activator	Yes	Yes
Mouthpiece Attachments	Same	Same
Storage	Travel Shell	Travel Case
USB Connector	No	Yes
Charging Port	Yes	No
Travel Shell	Yes	No
Travel Case	No	Yes
LED Battery Charge Indicator	Yes	Yes
Audible On/Off Switch	No	Yes
Shelf Life	2.0 years	2.0 years
Battery Life	2.5 years	2.0 years*

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Image /page/3/Picture/0 description: The image contains the logo for OrthoAccel Technologies, Inc. The logo features the company name in a bold, sans-serif font, with a stylized graphic above the name. The graphic consists of three curved lines that resemble sound waves or vibrations. Below the company name, the words "Technologies, Inc." are printed in a smaller font size.

AcceleDent Aura Special 510(k) NOTIFICATION

*Device deactivates after equivalent of 18 months of 20 minute daily sessions.

Intended Use:

AcceleDent® Aura is intended for use during orthodontic treatment. It is used in conjunction with orthodontic appliances such as braces and helps facilitate minor anterior tooth movement.

Substantial Equivalence Discussion:

A thorough design control review of the modifications made in the AcceleDent® Aura has demonstrated that the device will perform safely and as intended when compared to the AcceleDent®. As a result, the AcceleDent® Aura is substantially equivalent to the predicate AcceleDent®.

Performance Testing:

Risk Analysis was performed according to ISO 14971 and the results supported implementation of the modifications. Verification testing to IEC 60601 and device specifications supplemented the analysis performed. Results of the analysis and testing showed that performance of the modifications met device specifications and further demonstrated substantial equivalence.

Clinical Testing:

No further clinical data were collected for AcceleDent® Aura.

Conclusions:

Based on the information provided in this premarket notification, it is concluded that the AcceleDent® Aura is safe and effective and is substantially equivalent to the predicate device which was the original AcceleDent®.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

Public Health Service

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

April 23, 2013

Mr. Zaffer Syed Director, Clinical & Regulatory Affairs OrthoAccel® Technologies, Incorporated 6575 West Loop South, Suite 200 BELLAIRE TX 77401

Re: K130643

Trade/Device Name: AcceleDent® Aura Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: OYH Dated: March 21, 2013 Received: March 26, 2013

Dear Mr. Syed:

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 devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

ﺴﺴ

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Kwame O. Ulmer for
-S HDA

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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O: Incaccel

AcceleDent Aura™ جcial 510(k) NOTIFICATION

Indication for Use

K130643 510(k) Number (if known): Not Assignet

Device Name: AcceleDent® Aura

Indication For Use:

AcceleDent® Aura is 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 __ × (21 CFR Part 801 Subpart D) AND/OR

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office Device Evaluation (ODE)

Mary S. Runner -S 013:04.23 12:11:09 00 04'00'

Division Sign-Off

510(k) K130643

Regulation Number and Section

§ 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.