(39 days)
Ceraloy Solder is intended to be used by dentists and dental laboratories as a solder for Ceraloy alloy. It is used in the repair and fabrication of crowns, veneers, onlays, 34 crowns, short and long span bridgework and PFM restorations.
Not Found
This letter from the FDA is a determination of substantial equivalence for a medical device called "Ceraloy Solder," not a study that proves the device meets specific acceptance criteria based on performance data. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be extracted from the provided text.
The document indicates that the device is a "Base Metal Alloy" (Regulation Number: 872.3710) and is considered substantially equivalent to pre-amendments devices. This means its safety and effectiveness are deemed comparable to predicate devices already on the market, rather than being demonstrated through a contemporary performance study against specific acceptance criteria.
Here's what can be stated based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The letter does not detail specific acceptance criteria for performance nor does it report any device performance metrics. It's a regulatory clearance based on substantial equivalence, not a performance study report.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The letter does not describe any specific test set, its sample size, or the provenance of any performance data.
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)
- Cannot be provided. No information about a test set or ground truth establishment is present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No information about a test set or adjudication method is present.
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
- No such study was done or reported. This type of study relates to AI-assisted diagnostics, which is not applicable to a "Base Metal Alloy" solder.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No information about ground truth is present.
8. The sample size for the training set
- Not applicable. This device is a physical dental material, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable. This device is a physical dental material, not a machine learning algorithm.
In summary, the provided document is a regulatory clearance letter (510(k)) based on substantial equivalence. It does not contain the kind of performance data or study details that would allow for an answer to the requested questions about acceptance criteria and study design.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 6 2002
Neirynck & Vogt NV C/O Mr. Josh Andrachek Vacalon Company, Incorporated 12960 Stonecreek Drive Pickerington, Ohio 43147
Re: K021968
Trade/Device Name: Ceraloy Solder Regulation Number: 872.3710 Regulation Name: Base Metal Alloy Regulatory Class: II Product Code: EJH Dated: June 17, 2002 Received: June 17, 2002
Dear Mr. Andrachek:
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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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 (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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
Patricia Ciccantelli for
Timothy A. Ulatowski 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
Page 1 of 1
510(k) Number (if known): K021968
Device Name: Ceraloy Solder
Indications for Use:
Ceraloy Solder is intended to be used by dentists and dental laboratories as a solder for Ceraloy alloy. It is used in the repair and fabrication of crowns, veneers, onlays, 34 crowns, short and long span bridgework and PFM restorations.
(Please do not write below this line- Continue on another page if needed)
Prescription Use (Per 21 CFR 801-109) OR
Over-the-counter Use
(optional; format 1-2-96)
AutsBetz mps for Dr Susan Runner.
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number_ 0
§ 872.3710 Base metal alloy.
(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is 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.