PROGOLD ELECTROCOPING SYSTEM by MICRO DENTAL LABORATORIES

I am sorry, but the provided text does not contain the detailed study information required to answer your request about acceptance criteria and device performance. The document is a 510(k) clearance letter from the FDA for a dental system called "ProGold - Gold Electrocoping System." It states that the device is substantially equivalent to previously marketed devices but does not include any specifics about clinical studies, performance metrics, acceptance criteria, or sample sizes.

Therefore, I cannot extract the following information:

A table of acceptance criteria and the reported device performance
Sample sizes used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size
If a standalone performance study was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

Summary

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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 stylized eagle with its head facing left and its wings forming three horizontal lines. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Nicolas E. Azar Director Research & Development Micro Dental Laboratories 6665 Amador Plaza Road Dublin, California 94568

MAR - 9 1998

Re : K980613 Progold Electrocoping System Trade Name: Requlatory Class: II EJT Product Code: February 9, 1998 Dated: February 18, 1998 Received:

Dear Mr. Azar:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes. compliance with ... ... the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Azar

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Patrici Cucurati/for

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): Not Known

Device Name: ProGold - Gold Electrocoping System

. .

(Per 21 CFR 801.10)

Indications For Use: Fabrication of 24 karat 99.96% pure gold substructure for porcelain fused to metal restorations.

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Concurrence of CDRH, Office of Device Evaluation ( ODE )

(Division Sign-Off)	PDS for MSR
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	6980613

Prescription Use	3/2	OR	Over-The-Counter Use	No
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(Optional Format 1-2-96)

Regulation Number and Section

§ 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.