(72 days)
Orthodontic Ceramic Brackets are indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
The ORTHODONTIC CERAMIC BRACKETS are designed to move teeth to improve their alignment.
The ORTHODONTIC CERAMIC BRACKETS are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.
No accessories are marketed with the ORTHODONTIC CERAMIC BRACKETS. The dental clinician is free to choose the bonding cement, supplemental ligatures and orthodontic wires for use with the brackets.
The provided text describes an orthodontic ceramic bracket device seeking 510(k) clearance, not a medical device involving AI or complex software. As such, many of the requested categories (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are not applicable to the information provided in this 510(k) summary.
The regulatory submission for the "Orthodontic Ceramic Brackets" focuses on demonstrating substantial equivalence to predicate devices through bench testing of physical properties, rather than clinical efficacy studies often associated with advanced diagnostic or AI-powered devices.
Here's an analysis based only on the provided text, indicating where information is not applicable (N/A):
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state quantitative "acceptance criteria" for the bench tests in the format of a target value or range. Instead, it states that "performance was achieved and validated." It implies that the newly proposed device's performance in these tests was comparable to that expected of orthodontic ceramic brackets and sufficient to demonstrate substantial equivalence to the predicate devices.
| Test Type | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Friction Tests | Performance achieved and validated | Performance achieved and validated |
| Flexural Strength | Performance achieved and validated | Performance achieved and validated |
| Translucency | Performance achieved and validated | Performance achieved and validated |
| Shear Bond Tests | Performance achieved and validated | Performance achieved and validated |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. The submission mentions "bench testing," implying lab-based evaluation, but does not detail the number of samples used for each test or the origin of any materials beyond the statement that the device is "composed of a polycrystalline alumina ceramic bracket." The testing is prospective for the new device as it's part of its pre-market submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
N/A. This device is an orthodontic bracket, and its performance evaluation through bench testing does not involve "ground truth" established by human experts in the manner of diagnostic AI. Its performance is assessed through physical property measurements.
4. Adjudication Method for the Test Set
N/A. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters, especially for subjective assessments. Bench testing of physical device properties does not involve such methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Assistance
N/A. This is not an AI-powered device, nor does it involve human readers interpreting data. Therefore, an MRMC study and AI assistance effect size are not relevant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This is a physical medical device (orthodontic bracket), not an algorithm or software. Therefore, standalone algorithm performance is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by objective physical measurements (friction, flexural strength, translucency, shear bond) according to established engineering and material science principles, and comparison to the characteristics of legally marketed predicate devices. It's not based on expert consensus, pathology, or outcomes data in a clinical sense for its performance metrics.
8. The Sample Size for the Training Set
N/A. As this is a physical device and not an AI/ML model, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
N/A. See point 8.
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510(k) Summary
per 21CFR807.92
CONTACT:
DEC 1 3 2012
Mr. Jinichi Watanabe Manager, Legal Sec. TOMY, Inc. Tenko Bldg. 3-16-7 Midoricho, Fuchu City, Tokyo 183-0006 Japan
DATE PREPARED: November 1, 2012
TRADE OR PROPRIETARY NAME: ORTHODONTIC CERAMIC BRACKETS
CLASSIFICATION NAME: Bracket, Ceramic, Orthodontic, 872.5470
PREDICATE DEVICES:
In-Ovation C ceramic brackets (K060837) Mystique MB ceramic brackets (K082974)
DEVICE DESCRIPTION: The ORTHODONTIC CERAMIC BRACKETS are designed to move teeth to improve their alignment.
The ORTHODONTIC CERAMIC BRACKETS are bonded to natural teeth by dental professionals to connect with orthodontic wires to cause tooth movement to a more preferred position.
No accessories are marketed with the ORTHODONTIC CERAMIC BRACKETS. The dental clinician is free to choose the bonding cement, supplemental ligatures and orthodontic wires for use with the brackets.
INTENDED USES: The ORTHODONTIC CERAMIC BRACKETS are indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
TECHNOLOGICAL CHARACTERISTICS: The ORTHODONTIC CERAMIC BRACKETS are composed of a polycrystalline alumina ceramic bracket, which includes an archwire slot and tiewings. The self-ligating ORTHODONTIC CERAMIC BRACKETS have a metal clip so that no other ligation of the archwire is needed.
Bench testing was performed to ensure that the ORTHODONTIC CERAMIC BRACKETS' performance was achieved and validated, which consisted of friction tests, flexural strength measurements, translucency, and shear bond tests.
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The ORTHODONTIC CERAMIC BRACKETS were not evaluated for biocompatibility The ORTHODON He oblighten proven to be safe. All of the components have been because aramma has long over cate orthodontic ceramic brackets. No new questions of safety and effectiveness are raised with these devices.
SUBSTANTIAL EQUIVALENCE: No differences exist between these ORTHODONTIC SUBSTANTINE DQ OTTING DQ THIC Dredicate devices currently marketed in intended use, composition, design, function, physical properties, or performance. We believe that composition, design, function, physical propostrate these ORTHODONTIC CERAMIC the performance and provided tially equivalent in safety and effectiveness to the predicate device.
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Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or other bird-like figure. The symbol is black and has a flowing, abstract design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 13, 2012
TOMY, Incorporated C/O Carolyn M. Primus, PhD Consultant Primus Consulting 7046 Owl's Nest Terrace BRADENTON FL 34203
Re: K123094 -
Trade/Device Name: Orthodontic Ceramic Brackets Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NJM Dated: September 28, 2012 Received: October 25, 2012
Dear Dr. Primus:
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 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 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,
Kwame O. Ulmer
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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Indications for Use
510(k) Number (if known): K12 3 C 94
Device Name: ORTHODONTIC CERAMIC BRACKETS
Indications For Use: Orthodontic Ceramic Brackets are indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.
Prescription 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 NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) 2012.12.13 Page 1 of 1 Susan Runner DDS, MA -07:01:32 -05'00'
(Division Sign-Off) rhot Notification Tomy, Inc. ORTHODONTIC CERAMIC BRACKETS Division of Anesthesiology, General Hosp Infection Control, Dental Devices
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K123094 510(k) Number:_
§ 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.