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I apologize, but the provided text from the FDA 510(k) clearance letter for the "Jumbo Silver-Reinforced Glass Ionomer" device does not contain the detailed information necessary to answer your request about acceptance criteria, study design, and performance metrics.
The document is a clearance letter, which means the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It primarily focuses on regulatory compliance, classification, and permissions to market the device. It does not include:
- A table of acceptance criteria or reported device performance.
- Details about sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods.
- Information about MRMC comparative effectiveness studies, standalone algorithm performance, or the type of ground truth used.
- Details regarding the training set size or how its ground truth was established.
To obtain this information, you would typically need to refer to the original 510(k) submission document itself, which contains the detailed technical and clinical performance data submitted by the manufacturer to the FDA. Such documents are usually much more extensive than the clearance letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1098
Mr. John Discko Executive Vice President Centrix, Incorporated 770 River Road Shelton, Court 06484-5458
K982665 Re : Trade Name: Jumbo Silver-Reinforced Glass Ionomer Regulatory Class: II Product Code: EMA Dated: July 21, 1998 Received: July 24, 1998
Dear Mr. Discko:
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 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). You may, therefore, market the device, subject to the qeneral 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations 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 requirements, 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Discko
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) 594-4692. 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 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.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
S. Butman 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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K982.665
Paqe
of
Dist Kasysysl 510 (k) NUMBER (IF KNOWN) : Silver Kein DEVICE NAME: INDICATIONS FOR USE:
alass MA one
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
NAN (Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number
OR
Over - The - Counter - Use (Optional Format 1-2-96)
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.