(123 days)
Edgewise and Roth Ceramic Brackets are intended for use in orthodontic treatments. The brackets are affixed to teeth so that pressure can be exerted on the teeth.
Edgewise and Roth Ceramic Brackets are intended to be bonded to teeth, upon which an orthodontic wire is used to move the teeth to new positions. The Morelli bracket consists of a translucent alumina body. The bracket is uncoated. The Morelli bracket is not self-bonding and requires a primer and adhesive to bond the bracket to the teeth.
The provided text is a 510(k) summary for Edgewise Ceramic Brackets and Roth Ceramic Brackets by Dental Morelli Ltda. It describes the device, its intended use, and compares it to a predicate device (Clarity Advanced Ceramic Brackets by 3M Unitek Corporation, K102803).
This document does not describe a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device. Instead, it demonstrates substantial equivalence to an already legally marketed device to obtain FDA clearance for a physical medical device (orthodontic brackets).
Therefore, I cannot provide an answer that includes:
- A table of acceptance criteria and reported device performance (as these are not defined for an AI/ML device in this document).
- Sample size for a test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, or training set details (as these are relevant for AI/ML studies, not this type of medical device clearance).
- Type of ground truth (as it would be relevant for an AI/ML study, not for demonstrating substantial equivalence of a physical bracket).
The document focuses on comparing the new device's characteristics (materials, indications for use, anatomical site, location of use, etc.) to a predicate device. The "acceptance criteria" here is effectively the demonstration of sufficient similarity and safety/effectiveness compared to the legally marketed predicate device.
However, I can extract the information related to the device comparison, which serves as the basis for establishing "acceptance" for clearance in this context:
Acceptance Criteria and Device Performance (based on Substantial Equivalence to Predicate Device)
The "acceptance criteria" for the Edgewise and Roth Ceramic Brackets are met by demonstrating their substantial equivalence to the predicate device, Clarity Advanced Ceramic Brackets (K102803). This means the new devices exhibit similar performance and safety characteristics.
Table 1: Device Comparison ("Acceptance Criteria" through Substantial Equivalence)
| Characteristic | Edgewise Ceramic Brackets by Dental Morelli | Roth Ceramic Brackets by Dental Morelli | Predicate: Clarity Advance Ceramic Brackets by 3M Unitek Corporation (K102803) |
|---|---|---|---|
| Indications for use | Intended for use in orthodontic treatments. Affixed to teeth to exert pressure. | Intended for use in orthodontic treatments. Affixed to teeth to exert pressure. | Intended for use in orthodontic treatments. Affixed to teeth to exert pressure. |
| Target Population | Patients in need of teeth alignment correction | Patients in need of teeth alignment correction | Patients in need of teeth alignment correction |
| Anatomical Site | Teeth | Teeth | Teeth |
| Location of use | Use only by professional orthodontists | Use only by professional orthodontists | Use only by professional orthodontists |
| Materials | Aluminum oxide | Aluminum oxide | Aluminum oxide |
| Biocompatibility | Aluminum oxide is medical grade and accepted for ceramic brackets. | Aluminum oxide is medical grade and accepted for ceramic brackets. | Aluminum oxide is medical grade and accepted for ceramic brackets. |
| Compatibility with the environment and other devices | Aluminum oxide is medical grade and accepted for ceramic brackets. | Aluminum oxide is medical grade and accepted for ceramic brackets. | Aluminum oxide is medical grade and accepted for ceramic brackets. |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Maxillary In-out (mm) | 0.94 | 0.6-1.2 | 0.53-.089 |
| Maxillary Torque | 0 | -7 to +8 | -7 to +17 |
| Maxillary Angulation | 0 | 0 to +12 | 0 to +8 |
| Mandibular In-out (mm) | 0.94 | 0.6 - 1.2 | 0.51-1.14 |
| Mandibular Torque | 0 | -22 to 0 | -17 to 0 |
| Slot | 0.022" | 0.022" | 0.022" |
Study/Evaluation Proving Acceptance:
The non-clinical data and biocompatibility evaluation presented in the 510(k) submission served as the "study" to prove the device meets acceptance criteria by demonstrating substantial equivalence.
- Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML study involving a test dataset for algorithm performance. The "test set" is the physical device being compared. Data provenance is not described in this context beyond the device's characteristics and materials.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For a physical device like an orthodontic bracket, "ground truth" relates to material properties, dimensions, and performance characteristics consistent with established standards or the predicate device. The core "ground truth" for clearance is the performance and safety profile of the legally marketed predicate device. The new device's characteristics are compared against this established profile.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary: The "acceptance criteria" for these orthodontic ceramic brackets were met by demonstrating that they are substantially equivalent to a predicate device (Clarity Advanced Ceramic Brackets) in terms of intended use, indications for use, materials, design, and performance characteristics. The evaluation was a non-clinical comparison and biocompatibility assessment, not a clinical trial or AI/ML performance study.
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Image /page/0/Picture/1 description: The image shows the logo for Morelli Ortodontia. The logo features a stylized "X" shape above the word "MORELLI" in bold, block letters. Below "MORELLI" is the word "ORTODONTIA" in smaller, block letters. A horizontal line is underneath the word "ORTODONTIA".
Dental Morelli Ltda.
| SECTION 6 | |
|---|---|
| 510(k) SUMMARY | |
| Proprietary Name | Edgewise Ceramic Brackets; Roth CeramicBrackets |
| Date Prepared | April 15, 2013 |
| Submitter | DENTAL MORELLI LTDAAlameda Jundiaí, 230 -Jardim Saira - SorocabaCEP: 18085-090BrazilTelephone: 55 (15) 3238-8200 |
| Official Contact | Tara ConradTechLink International Consulting18851 NE 29th AvenueSuite 720Aventura, FL 33180TEL- (305) 377-0077 |
| Common Name | Orthodontic Ceramic Brackets |
| Trade Name | Edgewise Ceramic Brackets; Roth CeramicBrackets |
| Classification | Class II |
| Product Code | NJM |
| Classification Panel | Dental |
| Regulation Numbers | 21 CFR 872.5470 |
| Substantial Equivalence | K102803 Clarity Advanced Ceramic Brackets |
AUG 2 7 2013## Description of Proposed Device
Edgewise and Roth Ceramic Brackets are intended to be bonded to teeth, upon which an orthodontic wire is used to move the teeth to new positions. The Morelli bracket consists of a translucent alumina body. The bracket is uncoated. The Morelli bracket is not self-bonding and requires a primer and adhesive to bond the bracket to the teeth.
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Image /page/1/Picture/0 description: The image shows the text "Dental Morelli Ltda." in a bold, sans-serif font. The text is arranged horizontally, with each word clearly legible. The background is plain white, which makes the text stand out prominently.
Image /page/1/Picture/1 description: The image shows a logo for a company called "Morelli Ortodontia". The logo consists of a stylized "X" shape above the company name. The "X" shape is made up of two curved lines that intersect in the middle. The company name is written in a bold, sans-serif font.
Indications for Use
Edgewise and Roth Ceramic Brackets are intended for use in orthodontic treatments. The brackets are affixed to teeth so that pressure can be exerted on the teeth.
Device Comparison Table
| Edgewise CeramicBrackets by DentalMorelli | Roth CeramicBrackets by DentalMorelli | Clarity AdvanceCeramic Bracketsby 3M UnitekCorporationK102803 | |
|---|---|---|---|
| Indications for use | Edgewise and RothCeramic Bracketsare intended foruse in orthodontictreatments. Thebrackets areaffixed to teeth sothat pressure canbe exerted on theteeth. | Edgewise and RothCeramic Bracketsare intended foruse in orthodontictreatments. Thebrackets areaffixed to teeth sothat pressure canbe exerted on theteeth. | Clarity AdvancedCeramic Bracketsare intended foruse in orthodontictreatments. Thebrackets areaffixed to teeth sothat pressure canbe exerted on theteeth. |
| Target Population | Patients in need ofteeth alignmentcorrection | Patients in need ofteeth alignmentcorrection | Patients in need ofteeth alignmentcorrection |
| Anatomical Site | Teeth | Teeth | Teeth |
| Location of use | Use only byprofessionalorthodontists | Use only byprofessionalorthodontists | Use only byprofessionalorthodontists |
| Materials | Aluminum oxide | Aluminum oxide | Aluminum oxide |
| Biocompatibility | Aluminum oxide ismedical grade andis accepted forceramic brackets | Aluminum oxide ismedical grade andis accepted forceramic brackets | Aluminum oxide ismedical grade andis accepted forceramic brackets |
| Compatibility withthe environmentand other devices | Aluminum oxide ismedical grade andis accepted forceramic brackets | Aluminum oxide ismedical grade andis accepted forceramic brackets | Aluminum oxide ismedical grade andis accepted forceramic brackets |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Maxillary In-out(mm) | 0.94 | 0.6-1.2 | 0.53-.089 |
| Maxillary Torque | 0 | -7 to +8 | -7 to +17 |
| MaxillaryAngulation | 0 | 0 to +12 | 0 to +8 |
| Mandibular In-out(mm) | 0.94 | 0.6 - 1.2 | 0.51-1.14 |
| Mandibular Torque | 0 | -22 to 0 | -17 to 0 |
| Slot | 0.022" | 0.022" | 0.022" |
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Image /page/2/Picture/1 description: The image shows a logo for Morelli Ortodontia. The logo features a stylized "X" shape at the top, which is made up of geometric shapes. Below the "X" is the word "MORELLI" in a bold, sans-serif font, and below that is the word "ORTODONTIA" in a smaller, sans-serif font.
Substantial Equivalence
Both the non-clinical data and the biocompatibility evaluation indicate that Edgewise and Roth Ceramic Brackets are safe and effective for their intended use in orthodontic treatment and perform as well as the predicate. The subject and predicate devices have the same intended use, indications for use, compositions, device design and performance.
Device Material and Design
The body of the subject and predicate devices are composed of ceramic. The Edgewise and Roth Ceramic Bracket is not coated and does not have a liner. The Morelli Brackets have rounded edges and corners. The Edgewise and Roth Ceramic Bracket is not built to facilitate debonding.
Conclusion
This premarket notification is being submitted to request clearance for the Edgewise and Roth Ceramic Brackets. The analysis on the Edgewise Ceramic Brackets demonstrates substantial equivalence to the 3M Unitek Corporation predicate.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 27, 2013
Dental Morelli Limited C/O Ms. Tara Conrad Regulatory Affairs Manager Techlink International Consultants 18851 NE 29th Avenue Suite 720 AVENTURA FL 33180
Re: K131197
Trade/Device Name: Edgewise Ceramic Brackets; Roth Ceramic Brackets Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: May 15, 2013 Received: June 4, 2013
Dear Ms Conrad:
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 four of 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. Conrad
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 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 http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Kwame Ulmer M.S. Acting Division 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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Indications for Use Statement
Edgewise and Roth Ceramic Brackets are intended for use in orthodontic treatments. The brackets are affixed to teeth so that pressure can be exerted on the teeth.
Perscription Use ____________ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _______________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED
Sheena A. Green -5
2013.08.27 14:29:58 -04-0000 for M. Susan Runner, DDS, MA
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 131197
Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1
Page 11 of 84 Traditional 510(k) Dental Morelli Ceramic Brackets
§ 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.