(18 days)
Elation MB metal reinforced plastic brackets is indicated for orthodontic movement of natural teeth.
The marketed product Elation Metal Reinforced Plastic Brackets has a barrel polished bonding base. A modification has been made to replace the base with the previously tested mechanical lock base and an improvement in the tie wing, Elation MB Metal Reinforced Plastic Brackets.
The provided document is a 510(k) summary for a medical device (Elation MB Metal Reinforced Plastic Brackets), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance data in the format typically used for software or AI/ML device evaluations. Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of statistical metrics, sample sizes, expert ground truth, and comparative effectiveness studies is not applicable or available in this type of regulatory submission.
This document describes a modification to an existing device and justifies its safety and substantial equivalence based on prior use of components and material composition, not through a performance study that measures diagnostic accuracy or clinical outcomes with quantifiable metrics against acceptance criteria.
However, I can extract and infer some information based on the context of a 510(k) submission for a non-software/AI device:
1. A table of acceptance criteria and the reported device performance
For a mechanical device like an orthodontic bracket, "acceptance criteria" usually relate to mechanical strength, biocompatibility, and fit, often tested against industry standards or the performance of a predicate device. The document states that the device meets these, but detailed quantitative criteria and performance values are not provided in this summary.
| Acceptance Criteria Category (Inferred) | Reported Device Performance (Inferred from document) |
|---|---|
| Biocompatibility | "All of the components found in Elation MB Metal Reinforced Plastic Brackets have been used in legally marketed devices and/or were specified on the basis of having biocompatibility data..." |
| Mechanical Lock/Bonding | "A modification has been made to replace the base with the previously tested mechanical lock base..." (Implies meeting performance of the predicate's mechanical lock) |
| Material Composition & Safety | "All of the components... were found safe for dental use. The performance data provided, and the bio-compatibility data support the use of Elation MB Metal Reinforced Plastic Brackets for the indicated uses." |
| Equivalence to Predicate Indications for Use | "Elation MB is indicated for orthodontic movement of natural teeth." (Matches the inferred indication of the predicate devices) |
2. Sample sizes used for the test set and the data provenance
Not applicable in the context of this 510(k) summary. This document does not describe a clinical or performance study with a test set of data points in the way a software/AI device would. The "tests" here refer to material and mechanical evaluations, likely performed on a sufficient number of bracket samples to ensure product quality and regulatory compliance, but specific sample sizes are not disclosed in this summary. Data provenance is not described as it is not a data-driven device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for a mechanical device like this is established through material science principles, engineering testing (e.g., tensile strength, bond strength), and biocompatibility assessments, not by expert consensus on clinical cases.
4. Adjudication method for the test set
Not applicable. There is no "test set" in the context of clinical cases 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 is a physical orthodontic bracket, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical orthodontic bracket.
7. The type of ground truth used
For a non-AI/ML medical device like this, the "ground truth" is typically:
- Material Science Specifications: Conformance to established standards for materials (e.g., plastics, metals used in the bracket).
- Biocompatibility Data: Established safety profiles for the materials used, often from prior regulatory clearances or published standards.
- Mechanical Engineering Principles: Performance of the mechanical lock, retention, and overall structural integrity, verified through in-vitro laboratory testing (e.g., bond strength tests).
- Predicate Device Performance: The underlying assumption that if the new device's materials, design modifications (like the base), and intended use are substantially equivalent to a legally marketed predicate device, its performance and safety are also equivalent.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model.
9. How the ground truth for the training set was established
Not applicable.
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(092030
Image /page/0/Picture/1 description: The image shows the word "DENTSPLY" in a bold, sans-serif font. The letters are all capitalized and black. The letter "T" has a unique design, with a triangular shape cut out of the lower right corner.
1 .
510(k) SUMMARY for Elation MB Metal Reinforced Plastic Brackets
- Submitter Information: DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405
JUL 2 4 2809
DENTSPLY International World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 (800) 877-0020 Fax (717) 849-4343 www.dentsply.com
Contact Person: Helen Lewis 717-849-4229 Telephone Number: 717-849-4343 Fax Number:
2 July 2009 Date Prepared:
2. Device Name:
- Elation MB Metal Reinforced Plastic Brackets . Proprietary Name:
- Classification Name: .
Bracket Plastic Orthodontic
-
872.5470
II -
CFR Number: . Device Class: .
-
DYW . Product Code:
Sponsor's Predicate Device: 3.
| Company | Device | 510(k) Number | Date Cleared |
|---|---|---|---|
| GAC International | Elation | K942826 | 12/14/1994 |
| DENTSPLY International Inc | Mystique MB CeramicBracket | K082974 | 11/07/2008 |
| DENTSPLY International Inc | Allure MB Ceramic Brackets | K090454 | 03/20/2009 |
4. Description of Device:
The marketed product Elation Metal Reinforced Plastic Brackets has a barrel polished bonding base. A modification has been made to replace the base with the previously tested mechanical lock base and an improvement in the tie wing, Elation MB Metal Reinforced Plastic Brackets.
-
- Indications for Use:
Elation MB is indicated for orthodontic movement of natural teeth.
- Indications for Use:
000009
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Description of Safety and Substantial Equivalence:
Technological Characteristics.
The Elation MB metal reinforced plastic brackets represents a modification to K942826.
All of the components found in Elation MB Metal Reinforced Plastic Brackets All of the components tound in Llation 112 norder were found safe for dental use.
have been used in legally marketed devices and/or were specition on the nave been used in legally markets co reast and the same composition as the Elation NID Metal Kennorood Flastro Enterestibility testing is not necessary:
We believe that the prior use of the component of Elation MB Metal Reinforced Plastic We believe that the prof as of the composited. The performance data provided, and the Brackets in legally marketed devices, the partiniates and provincess of Elation brocompationity catal Plastic Brackets for the indicated uses.
INTENSE
000010
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three bars below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 4 2009
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872
Re: K092030
Trade/Device Name: Elation MB Metal Reinforced Plastic Brackets Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: DYW Dated: July 2, 2009 Received: July 6, 2009
Dear Ms. Lewis:
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.
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. Lewis
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 (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 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 to http://www.fda.gov/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Susan Gunner
Susan Runner, D.D.S., M.A. Acting 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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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K09 2030
Device Name: Elation MB metal reinforced plastic brackets
Indications for Use:
Elation MB metal reinforced plastic brackets is indicated for orthodontic movement of natural teeth.
Prescription Use X (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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kevin Mulvey for MSR
(Division Sign Off)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092030
§ 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.