(64 days)
CERA F ALLOY is indicated as a dental alloy for fabricating inlays, crowns, bridges, precision milling bars and attachments, and crowns and bridges for porcelain fused to metal technique.
CERA F ALLOY is a gold-based dental alloy for prosthodontic devices.
This document is a 510(k) premarket notification for a dental alloy, CERA F ALLOY. It is important to note that this is NOT a study report for an AI/ML-based medical device. Therefore, most of the requested information regarding acceptance criteria, study design, expert ground truth, and human-in-the-loop performance is not applicable or cannot be extracted from this document.
However, I can provide the available information:
1. A table of acceptance criteria and the reported device performance
This document does not provide specific acceptance criteria or quantitative performance metrics for CERA F ALLOY in the typical sense of a diagnostic or treatment AI device. Instead, the "performance" is based on its similarity to legally marketed devices and its historical use.
| Acceptance Criteria Type | Reported Device Performance (Summary) |
|---|---|
| Technological Characteristics (Composition) | "All of the components found in CERA F ALLOY have been used in legally marketed devices." |
| Formulation Similarity | "CERA F ALLOY is very similar in formulation to legally marketed dental alloys." |
| Biocompatibility | "This alloy has been on the European market since 2001 with over 250,000 units placed. Therefore, it was determined that no biocompatibility testing was necessary." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study testing a device's diagnostic or predictive performance on a test set. The "performance data" referred to is historical use data.
The data provenance regarding historical use is:
- Country of Origin: Europe
- Retrospective/Prospective: Retrospective (historical use data from 2001 to 2003)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth as typically defined for AI/ML performance evaluation is not relevant to this type of device submission. The "ground truth" for this device's safety and effectiveness relies on the established safety of its component materials and its historical clinical use.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no test set or adjudication process as described for AI/ML performance studies.
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 device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dental alloy, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" (or basis for safety and effectiveness) for CERA F ALLOY is established through:
- Historical Use Data/Outcomes Data: "This alloy has been on the European market since 2001 with over 250,000 units placed." This implies that clinical outcomes and safety profiles from this extensive use were considered sufficient to forgo new biocompatibility testing.
- Component Material Precedent: "All of the components found in CERA F ALLOY have been used in legally marketed devices." This refers to the established safety and effectiveness of the individual constituent metals.
8. The sample size for the training set
Not applicable. This is not an AI/ML device. The "training" for this device's regulatory approval stems from the established safety history of its components and the product's historical use. The "sample size" for this historical use is "over 250,000 units placed" in Europe.
9. How the ground truth for the training set was established
Not applicable for an AI/ML "training set." As described above, the "ground truth" for the device's safety and effectiveness was established by:
- The established regulatory history and safety profiles of its constituent materials (components found in legally marketed devices).
- Real-world clinical use data ("over 250,000 units placed" in Europe since 2001) which implicitly includes long-term outcomes and absence of reported adverse events, negating the need for further biocompatibility testing.
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510(k) SUMMARY
NAME & ADDRESS:
SEP 3 0 2003
DENTSPLY International
70 West College Avenue O. Box 872 York, PA 17405-0872 717) 845-7511 772 840 1762 ww.dentsply.com
P. J. Lehn Telefax (717) 849-4343
P. Jeffery Lehn CONTACT:
July 25, 2003 DATE PREPARED:
TRADE OR PROPRIETARY NAME: CERA F ALLOY
Gold based alloy for clinical use (872.3060) CLASSIFICATION NAME:
PREDICATE DEVICES: Stabilor NF IV alloy K951780
DEVICE DESCRIPTION: CERA F ALLOY is a gold-based dental alloy for prosthodontic devices.
INTENDED USE: CERA F ALLOY is indicated as a dental alloy for fabricating inlays, crowns, bridges, precision milling bars and attachments, and crowns and bridges for porcelain fused to metal technique.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in CERA F ALLOY have been used in legally marketed devices.
CERA F ALLOY is very similar in formulation to legally marketed dental alloys. This alloy has been on the European market since 2001 with over 250,000 units placed. Therefore, it was determined that no biocompatibility testing was necessary.
We believe that the prior use of the components of CERA F ALLOY in legally marketed devices, the performance data provided, and the historical use of the device in Europe support the safety and effectiveness of CERA F ALLOY for the indicated uses.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human profiles facing to the right, stacked on top of each other.
Public Health Service
SEP 3 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. P Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872
Re: K032321
Trade/Device Name: Cera F Alloy Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: July 25, 2003 Received: July 28, 2003
Dear Mr. Lehn:
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 such 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 -Mr. Lehn
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): 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.
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), please contact the Office of Compliance at (301) 594-4613. 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 Division of 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/dsma/dsmamain.html
Sincerely yours,
Suser Purse
Susan Runner, DDS, MA Interim 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
(As Required by 21 CFR 807.87(e)
510(K) Number (if known):
Device Name:
CERA F ALLOY
Indications for Use:
Fabricating inlays, crowns, bridges, precision milling bars and attachments, and crowns and bridges for porcelain fused to metal technique.
MCG Lu for MSR
(Division Sign-O Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ V
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.