AcceleDent® Optima is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.

Device Description

The AcceleDent® Optima is an orthodontic accessory for the treatment of tooth malocclusion. AcceleDent® Optima should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment.

AI/ML Overview

The provided text is a 510(k) summary for the AcceleDent® Optima device, which is an orthodontic accessory. It focuses on demonstrating substantial equivalence to a predicate device (AcceleDent® Aura, K153048) rather than presenting a standalone study with clinical acceptance criteria for a new clinical claim.

Therefore, the document does not contain a study that proves the device meets clinical acceptance criteria in the way medical imaging or diagnostic devices typically would. Instead, it demonstrates that the modified device (AcceleDent® Optima) maintains the safety and performance characteristics of its predicate device, primarily through non-clinical (engineering, material, and software) testing.

Here's an attempt to extract the requested information based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria listed in the document are primarily for engineering, material, and software verification, ensuring the modified device functions safely and as intended, similar to its predicate. There are no clinical performance metrics (e.g., sensitivity, specificity, accuracy, or reduction in treatment time) with associated acceptance criteria reported in this document.

Test Category	Acceptance Criteria (Standards/Requirements)	Reported Device Performance
Biocompatibility	ISO 10993-5:2009 (E): CytotoxicityISO 10993-10:2010(E): Intracutaneous Reactivity Irritation, Maximization SensitizationISO/USP: Acute System Toxicity	"AcceleDent® Optima passed Biocompatibility testing."
Bioburden Enumeration	No identified acceptance criteria (for study purposes only).	"AcceleDent® Optima passed Bioburden Enumeration testing."
System Verification	"The full system requirements, which includes the medical device hardware and optional/external mobile application and cloud server software, met the requirements serving as enhancements over Aura."	"AcceleDent® Optima passed System Verification testing."
Firmware Unit Test Verification	"The design requirements for the AcceleDent® Optima firmware was tested." (No specific standards mentioned)	"AcceleDent® Optima passed Firmware Unit Verification testing."
SubSystem Test Verification	"The medical device hardware met the performance requirements of Aura for therapeutic force delivery, battery charging, usage logging, and environmental operation without the interface of optional/external software."	"AcceleDent® Optima passed SubSystem Verification testing."
IEC 60601 3rd ed. (Electrical Safety)	"Each applicable requirement from IEC 60601 3rd was treated as an acceptance criterion for the product and/or documentation." (Ensuring electrical safety for medical devices.)	"AcceleDent® Optima passed IEC 60601 3rd ed. testing."
IEC 62133 Battery Safety	"Each requirement from IEC 62133:2012 was treated as an acceptance criterion for the battery and/or documentation." (Covers charging, vibration, temperature cycling, short circuit, free fall, abuse, etc.)	"AcceleDent® Optima passed IEC 62133 Battery Safety testing."
Packaging Distribution Testing	ASTM D 4169-14, ASTM D 6198-12, ASTM D3951-10 (Standards for performance testing of shipping containers).	"AcceleDent® Optima passed Packaging Distribution testing."
DEHP	"Could contain more than or equal to 0.1% by mass of DEHP as per design requirements." (This appears to be a limit for detection, not an upper limit for presence.)	"AcceleDent® Optima passed DEHP testing."
Latex Evaluation	"Test was conducted for study purposed to substantiate the claim that the device is not intentionally manufactured with latex." (No specific acceptance criterion given, but aims to ensure no adverse biological reactions due to latex.)	"AcceleDent® Optima passed Latex testing."
HFE-75 (Summative Testing / Human Factors)	ANSI/AAMI HE75:2009/(R):2013 Human factors engineering - Design of medical devicesANSI/AAMI/IEC 62366:2007/(R)2013 & A1:2013 Medical Devices - Application of usability engineering to medical devices	"AcceleDent® Optima passed Summative testing." (Demonstrates safe and effective use by intended users).
Bluetooth Certification	Bluetooth SIG (Includes approval of BLE RF sub-system performance).	"AcceleDent® Optima passed Bluetooth Certification testing."
FCC Compliance Testing	IEC 60601 (specifically EMC testing standards). (Ensuring electromagnetic interference is within approved limits).	"AcceleDent® Optima passed FCC Compliance testing."
Physical Properties Testing for Mouthpiece	Hardness DIN ISO 7610Density DIN EN ISO 1183-1Tensile Strength DIN 53504/ISO 37Elongation at Break DIN 53504/ISO 37Tear Resistance ISO 34-1 Method B	No specific pass/fail values or ranges reported in this summary, just that the tests were performed.

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

The document does not specify exact sample sizes for each test where such information might be relevant (e.g., how many units were tested for biocompatibility, system verification, or human factors). It refers to "the full 3G system" or "the 3G product" as being tested.

The data provenance is from non-clinical testing performed by the manufacturer (OrthoAccel Technology Inc.) and potentially by third-party testing labs (e.g., for certifications like Bluetooth, FCC, IEC standards). The data is retrospective in the sense that it describes tests performed on the device. No country of origin for the internal testing data is specified, but the device is marketed in the US.

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

Not applicable. This is a 510(k) submission for a modified orthodontic accessory, relying on engineering and safety testing, not clinical studies requiring expert-established ground truth for a diagnostic outcome. The human factors testing ("Summative Testing") would have involved intended users, but they are not referred to as "experts establishing ground truth" in a diagnostic context.

4. Adjudication Method for the Test Set

Not applicable. This is not a study requiring adjudication of expert interpretations for a ground truth.

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

No MRMC comparative effectiveness study was mentioned or performed. This device is not an AI-assisted diagnostic tool.

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

Not applicable. This device is a physical orthodontic accessory; it does not have a standalone "algorithm-only" performance as would be relevant for an AI or diagnostic software device. Its function is to facilitate tooth movement in conjunction with traditional orthodontic treatment. The "software" aspect refers to data transfer and internal device control, not an AI diagnostic algorithm.

7. Type of Ground Truth Used

The "ground truth" for the tests performed is based on:

Established standards and regulations: e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety, ASTM for packaging, Bluetooth SIG, and FCC regulations.
Design requirements/specifications: for internal system, firmware, and subsystem verifications, ensuring the device meets its intended engineering performance.
Performance of the predicate device (AcceleDent® Aura): for verifying that the therapeutic force delivery, battery charging, usage logging, and environmental operation are maintained.

8. Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. No training set was used.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three figures in profile facing right.

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

May 26, 2017

OrthoAccel Technology Inc. Jouana Harris-Livings Director of Quality Assurance and Regulatory Affairs 6575 West Loop South, Suite 200 Bellaire, Texas 77401

Re: K170093

Trade/Device Name: AcceleDent® Optima Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: OYH Dated: April 20, 2017 Received: April 21, 2017

Dear Jouana Harris-Livings:

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.

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

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forth in the quality systems (OS) 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Lori A. Wiggins -S6

for

Tina Kiang, Ph.D. Acting 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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Image /page/2/Picture/0 description: The image shows the logo for OrthoAccel Technologies, Inc. The word "OrthoAccel" is written in a blue sans-serif font, with the first part of the word in a lighter shade of blue. The word "Technologies, Inc" is written in a smaller, gray sans-serif font below the first word. The logo is simple and modern, and it is likely used to represent the company's brand.

Modified AcceleDe 510(k) Premarket Notification

Indication for Use

510(k) Number (if known): K170093

Device Name: AcceleDent® Optima

Indication For Use:

AcceleDent® Optima is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners 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)

Division Sign-Off

510(k)

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Image /page/3/Picture/0 description: The image shows the logo for OrthoAccel. The word "Ortho" is in blue, and the word "Accel" is in gray. There are three curved lines to the left of the word "Ortho" that look like sound waves.

510(k) Summary - AcceleDent® Optima K170093

January 09, 2017 (updated May 26, 2017)

This summary of 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 200 Bellaire, TX 77401 Phone: 832-803-0339 Fax: 713-583-9972

Contact: Jouana Harris-Livings

Device trade name:	AcceleDent® Optima
Common name:	Orthodontic plastic bracket
Classification name:	Orthodontic plastic bracket
Regulation number:	21 CFR 872.5470
Classification:	Class II
Panel:	Dental
Product codes:	OYH
Product code names	Orthodontic vibratory accessory and orthodontic LED accessory
Predicate Device:	AcceleDent® Aura, 510(k) Number K153048

Indications for Use:

AcceleDent® Optima is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.

Device Description:

This Premarket Notification (510(k)) is being submitted because the legally marketed OrthoAccel Technologies, Inc. device AcceleDent® Aura has been modified. Although the technological characteristics of the device and the indications for use described in our previous 510(k) K153048 remain unchanged, the design, raw material, manufacturing processes and related software have changed, resulting in the creation of the AcceleDent® Optima device.

Software:

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Image /page/4/Picture/0 description: The image shows the logo for OrthoAccel. The logo features the word "Ortho" in blue, with three curved lines above it, resembling sound waves. To the right of "Ortho" is "-Accel" in gray, with a small registered trademark symbol next to it. The logo is simple and modern, using a clean font and a two-tone color scheme.

The changes in software within the AcceleDent® Optima device allows for wireless transfer of data confirmed by Bluetooth and FCC testing, with a Moderate Level of Concern as determined by the risk assessment. The changes neither affect the mechanism of which the force is applied, nor the indications for use.

Material Characteristics:

Changes have been made to both the material of the activator and the mouthpiece for the AcceleDent® Optima, although they are both still Elastomers as used in the AcceleDent® Aura. Verification testing and risk evaluation has deemed these updated materials as low risk to the user.

Manufacturing Process:

There have been some changes made to the manufacturing processes in the AcceleDent® Optima device. Unlike AcceleDent® Aura, AcceleDent® Optima Activator is waterproof and thus requires ultrasonic welding to maintain the required IP rating. Additionally, assembly processes have been modified to accommodate the new design and the addition of the Charging Case. However, all major internal device components are relatively the same – PCB assembly, battery (although a NiMH rather than a lithium battery is used), and motor with off-set weight.

Performance Data Table:

The table below lists all performance testing performed on the AcceleDent® Optima to ensure its safety and efficacy.

Test	Standards/Requirements
Biocompatibility	The biocompatibility testing consisted of the following tests: Cytotoxicity,Intracutaneous Reactivity Irritation, Maximization Sensitization, and ISO/USPAcute System Toxicity.Reference ISO 10993-5:2009 (E)Reference ISO 10993-10:2010(E)Reference ISO 10993-10:2010(E)
Description	The purpose of the biocompatibility testing was to verify that the users of theAcceleDent 3G/Optima device will not experience any biological adversereactions due to the product material, color, and manufacturing process.AcceleDent® Optima passed Biocompatibility testing.
BioburdenEnumeration	Since this test was conducted for study purposes only, there was no identifiedacceptance criteria.
Description	The bioburden testing was performed on the 3G mouthpiece and activator todetermine the total number of viable microorganisms on the medical device.AcceleDent® Optima passed Bioburden Enumeration testing.
System Verification	This testing verified that the full system requirements, which includes themedical device hardware and optional/external mobile application and cloudserver software, met the requirements serving as enhancements over Aura.
Description	The scope of the testing is to verify that the 3G product met all of its systemrequirements. The system is comprised of the Activator, Charging Case, CloudApp, Mobile App, and Web Portal.AcceleDent® Optima passed System Verification testing.
Firmware Unit TestVerification	No standards were utilized in this testing. The design requirements for theAcceleDent® Optima firmware was tested.
Description	The purpose of this test was to verify the firmware requirement were met byfirmware design.AcceleDent® Optima passed Firmware Unit Verification testing.
SubSystem TestVerification	This testing verified that the medical device hardware met the performancerequirements of Aura for therapeutic force delivery, battery charging, usagelogging, and environmental operation without the interface of optional/externalsoftware (i.e. mobile application, cloud server).
Description	The scope of this testing is to verify that the physical components of the 3GAcceleDent System function as intended. Devices under Test (DUT) are theActivator and Charging Case Assembly, AC Power Wall Adapter, CableAcceleDent® Optima passed SubSystem Verification testing.
IEC 60601 3rd ed.	Each applicable requirement from IEC 60601 3rd was treated as an acceptancecriterion for the product and/or documentation. The full 3G system was tested,which includes the medical device hardware and optional/external mobileapplication and cloud server software
Description	The scope of this testing was to perform all required medical device safetyverification tests outlined in IEC 60601-1 and associated standards for 3G toensure that it met all statutory requirements for electrical safety for medicaldevices sold in the US, Canada, the European Union and China.AcceleDent® Optima passed IEC 60601 3rd ed. testing.
IEC 62133 BatterySafety	Each requirement from IEC 62133:2012 was treated as an acceptance criterionfor the battery and/or documentation.
Description	This testing was conducted on the NiMH Cell Battery (17AAAH, 17AAAH1A6Z) toverify that it met all requirements of IEC 62133:2012. The CB Scheme testprocedure included the following tests: charging procedure, continuous low-rate charging, vibration, temperature cycling, incorrect installation, externalshort circuit, free fall, mechanical shock (crash hazard), thermal abuse, crushingof the cells, low pressure, overcharge, and forced discharge.AcceleDent® Optima passed IEC 62133 Battery Safety testing.
Packaging DistributionTesting	The following standards were used for testing:ASTM D 4169-14 Standard Practice for Performance Testing of ShippingContainers and SystemsASTM D 6198-12 Standard Guide for Transport Packaging DesignASTM D3951-10 Standard for Commercial Packaging
Description	The scope of this testing was to test the worse-case shipping scenario of 2patient kit boxes shipped in an over-pack box, and a single parcel shipment ofthe RMA box, due to the fact that RMA boxes are not shipped in an overpackbox. Two separate boxes were tested in this shipping scenario.AcceleDent® Optima passed Packaging Distribution testing
DEHP	The activator and mouthpiece could contain more than or equal to 0.1% bymass of DEHP as per design requirements.
Description	The purpose of the DEHP testing is to determine the amount of DiethylhexylPhtalate (DEHP) present in the 3G mouthpiece and activator.AcceleDent® Optima passed DEHP testing.
Latex Evaluation	Test was conducted for study purposed to substantiate the claim that thedevice is not intentionally manufactured with latex.
Description	The purpose of the latex testing was to ensure that the 3G device will notexperience any biological adverse reactions due to the presence of latex.AcceleDent® Optima passed Latex testing.
HFE-75 (SummativeTesting)	The following standards were utilized:ANSI/AAMI HE75:2009/(R):2013 Human factors engineering - Design of medicaldevicesANSI/AAMI/IEC 62366:2007/(R)2013 & A1:2013 Medical Devices - Application ofusability engineering to medical devices
Description	The Summative Testing was performed to demonstrate that the finalAcceleDent Optima System user interface can be used by the intended userssafely and effectively for the intended use and under the expected useconditions.AcceleDent® Optima passed Summative testing.
Bluetooth Certification	Bluetooth Radio Compliance was per Bluetooth SIG, which includes approval ofBLE RF sub-system performance.
Description	The purpose of the Bluetooth Radio Compliance Testing is to test theAcceleDent 3G activator to achieve both Bluetooth SIG- BQE Certificate andBluetooth SIG – RF Approval (Low Energy) Testing.AcceleDent® Optima passed Bluetooth Certification testing.
FCC ComplianceTesting	The FCC compliance testing is one of the required components of the IEC 60601testing (within the EMC testing). Refer to the IEC 60601 3rded. Study criteriaabove.
Description	Federal Communications Commission (FCC) testing is a requirement for allelectronic products that radiate unintentional emissions. Receiving the FCCMark certification certifies that the electromagnetic interference is under thelimits approved by the FCC.AcceleDent® Optima passed FCC Compliance testing.
Physical PropertiesTesting forMouthpiece	Hardness DIN ISO 7610
	Density DIN EN ISO 1183-1
	Tensile Strength DIN 53504/ISO 37
	Elongation at Break DIN 53504/ISO 37
	Tear Resistance ISO 34-1 Method B

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Image /page/5/Picture/0 description: The image shows the logo for OrthoAccel. The word "Ortho" is in blue and has three curved lines to the left of it, resembling sound waves. The word "Accel" is in gray and has a small registered trademark symbol to the right of it.

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Image /page/6/Picture/0 description: The image shows the logo for OrthoAccel. The word "Ortho" is in blue, and there are three curved lines to the left of the word. The word "Accel" is in gray, and there is a registered trademark symbol to the right of the word.

Substantial Equivalence Information:

This Premarket Notification is being submitted to demonstrate substantial equivalence of the AcceleDent® Optima to the existing AcceleDent Aura (K153048). The data within this submission exhibits that the indications for use and the technology used to produce the

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Image /page/7/Picture/0 description: The image shows the logo for OrthoAccel. The logo features the word "Ortho" in blue, followed by "-Accel" in gray. There are three curved lines above the word "Ortho" that resemble sound waves. The logo is simple and modern, and the colors are eye-catching.

0.25 N (25 grams) force level and 30 Hz frequency required to deliver the treatment are the same; thus, these two devices are substantially equivalent.

AcceleDent® Optima: Traditional 510(k), (5) Page 6 of 6

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.