(70 days)
Ceramage is light-curing polymer based crown and bridge, inlay, onlay composite resin materials for anterior and posterior.
CERAMAGE is intended for use for following:
- Used for crown restorations, e.g. jacket crowns and facing crowns for anterior and posterior, inlays, onlays, laminate vehove and upper structure of implants.
- Used for extra/intra-oral repair of crown restorations and defect prosthetic restorations.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a dental material called "Ceramage." This document does not contain any information about acceptance criteria or a study proving the device meets those criteria, as it is related to a medical device approval, not an AI/algorithm-based diagnostic tool.
Therefore, I cannot provide the requested information based on the input document. The questions you've asked (sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are highly relevant to the evaluation of AI/ML-based medical devices, but not to the approval of a dental resin material like Ceramage.
Here's why the questions don't apply to the provided document:
- Ceramage is a physical dental material (resin), not an AI/ML algorithm or diagnostic device. Its approval relies on demonstrating substantial equivalence to existing predicate devices based on material properties, biocompatibility, and intended use, not on performance metrics like sensitivity, specificity, or AUC against a ground truth.
- The document is a 510(k) clearance letter, not a study report or clinical trial summary. It states that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its approval.
- Concepts like "test set," "training set," "ground truth," "experts for ground truth," "adjudication," and "MRMC comparative effectiveness studies" are specific to the validation of diagnostic algorithms or software. They are not applicable to the assessment of a composite resin material.
If you have a document related to an AI/ML medical device, I would be happy to analyze it for the requested information.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 2005
Mr. David P. Morais Operations Manager ShoFu Dental Corporation 1225 Stone Drive San Marcos, California 92069-4059
Re: K050401
Trade/Device Name: Ceramage Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: February 1, 2005 Received: February 17, 2005
Dear Mr. Morais:
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 approvisions 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 such additional controls. Existing major regulations affecting (1 wr 1), it a 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 - Mr. Morais
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 moun that 1 Dr mas mas statutes and regulations administered by other Federal agencies. or the Act of ally I outsal the Act's requirements, including, but not limited to: registration 1 ou muse compry William (21 CFR Part 801); good manufacturing practice and noung (= = = = forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you don't the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj count Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Suette y. M. Michae. M.D.
Chiu Lin, Ph.D. 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
510(k) Number (if known): 〈〈○5040]
Device Name: Ceramage
Indications For Use:
Ceramage is light-curing polymer based crown and bridge, inlay, onlay composite resin materials for anterior and posterior.
CERAMAGE is intended for use for following:
-
Used for crown restorations, e.g. jacket crowns and facing crowns for anterior and . Osed for Crown restorations, org. Jacksons and upper structure of implants.
ﻢ -
posterior, inlays, onlays, laminate vehove and apple
Used for extra/intra-oral repair of crown restorations and defect prosthetic . restorations.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
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| Division of Anesthesiology, General Hospital, Infection Control. Dental Devices |
5:0(k) Number ________________________________________________________________________________________________________________________________________________________________
ix
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.