FIBREKOR POST SYSTEM by JENERIC/PENTRON, INC.

This appears to be a 510(k) clearance letter from the FDA for the "FIBREKOR POST SYSTEM ™". The letter itself does not contain the detailed information about acceptance criteria, study design, or performance metrics that would be present in the actual 510(k) submission.

Since the provided text is only the FDA's clearance letter and not the original submission, it does not include the specific details of the acceptance criteria or the study used to demonstrate substantial equivalence. The letter merely states that the device is "substantially equivalent" to predicate devices.

Therefore, I cannot provide the requested information based solely on the text provided. The information typically required for FDA clearance (and thus, to answer your questions) would be found in the 510(k) submission itself, which is not included here.

Here's what I can tell you based on the provided letter, and what would be missing to answer your questions fully:

Information NOT available in the provided text:

A table of acceptance criteria and the reported device performance: This would be in the detailed testing results section of the 510(k) submission.
Sample sizes used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not mentioned. This type of study is more common for diagnostic imaging AI than for a dental post system.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for a physical medical device like a dental post.
The type of ground truth used: Not applicable or mentioned.
The sample size for the training set: Not applicable for this type of device.
How the ground truth for the training set was established: Not applicable for this type of device.

What the letter does indicate:

Device Name: FIBREKOR POST SYSTEM ™
Indications For Use:
- Reinforcement of an endodontically involved tooth
- Retention of Core and or Core Material
Regulatory Class: I
Product Code: ELR
Type of Submission: 510(k) notification, indicating substantial equivalence to a predicate device. This means the device was determined to be as safe and effective as a legally marketed device that was on the market prior to May 28, 1976, or has been subsequently reclassified. For Class I devices, the general controls provisions of the Act apply.

To obtain the specific details you're asking about, one would typically need to review the full 510(k) submission for K983266, which is usually publicly available on the FDA website (though finding very old submissions might be challenging, or they may only contain a summary).

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 9 1998

Mr. Murray G. Gamberg Quality System Director Jeneric®/Pentron®, Incorporated 53 North Plains Industrial Road P.O. Box 724 Wallingford, Connecticut 06492-0724

K983266 Re: Fibrekor Post System Trade Name: Regulatory Class: I Product Code: ELR September 14, 1998 Dated: September 17, 1998 Received:

Dear Mr. Gamberg:

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 aqainst 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does 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 regulations.

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Page 2 - Mr. Gamberg

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 requlation (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" (21 CFR 807.97). Other qeneral 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/dsmamain.html".

Sincerely yours,

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):	K983266
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Device Name:FIBREKOR POST SYSTEM ™

Indications For Use:

Reinforcement of an endodontically involved tooth

Retention of Core and or Core Material

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

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Prescription Use Over-the-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number

Regulation Number and Section

§ 872.3810 Root canal post.

(a)
Identification. A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.(b)
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 the limitations in § 872.9.