UFI GEL HARD C by VOCO GMBH | FDA 510(k) Summary

Unfortunately, the provided document is a 510(k) clearance letter for the Ufi Gel Hard C, a denture relining resin. This type of document does not contain the detailed information required to fulfill your request about acceptance criteria and a study proving a device meets them.

The 510(k) process primarily demonstrates substantial equivalence to a predicate device, rather than requiring extensive clinical trials with specific performance metrics and rigorous statistical analysis as would be found in a PMA (Pre-Market Approval) application or a more detailed study report.

Therefore, I cannot provide the following information based on the given text:

A table of acceptance criteria and the reported device performance: This document doesn't specify acceptance criteria for performance metrics or present any performance data in this format.
Sample size used for the test set and the data provenance: No test set information is present.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information on expert review for a test set.
Adjudication method for the test set: Not applicable as there's no test set described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This is a material (denture resin), not an AI device, so MRMC studies and AI assistance are not relevant.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for a denture resin.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as performance data is not detailed.
The sample size for the training set: Not applicable as this is not an AI/software device with a training set.
How the ground truth for the training set was established: Not applicable.

To get this type of information, you would typically need a much more comprehensive study report, a PMA application, or a detailed scientific publication about a novel medical device, particularly for software or AI-driven diagnostics/therapeutics.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 2003

Voco GmbH Mr. Gerald W. Shipps Regulatory Affairs Consultant Cascades Device Consulting Associates 19379 Blue Lake Loop Bend, Oregon 97702-1923

Re: K030916

Trade/Device Name: Ufi Gel Hard C Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: March 21, 2003 Received: March 24, 2003

Dear Mr. Shipps:

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. Shipps

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). 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 vours.

foAwutoshacia

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

510(k) Number: K030916

Device Name: Ufi Gel Hard C (10:1)_

Indications for Use:

Hard permanent total or partial relinings to restore the functions of partial or complete dentures Lengthening of denture margins

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X OR Over-The-Counter Use _

Ken Muly for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K030916

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.