RESIN 4 by HARRY J. BOSWORTH CO.

This document does not contain information about acceptance criteria or a study proving device performance related to specific metrics like sensitivity, specificity, or accuracy.

Instead, it is a regulatory document stating that the FDA has reviewed the manufacturer's Section 510(k) notification and determined that the device is "substantially equivalent" to legally marketed predicate devices. This means it has similar intended use, technological characteristics, and safety and effectiveness as a device already on the market.

Therefore, I cannot provide the requested information, including:

A table of acceptance criteria and the reported device performance: This document does not define such criteria nor report performance metrics in that format.
Sample size used for the test set and the data provenance: Not mentioned. The substantial equivalence determination likely relies on comparison to a predicate device's characteristics rather than a new standalone clinical performance study with a test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not mentioned. The concept of "human readers improve with AI" is not relevant to this type of dental material device.
If a standalone performance study was done: Not explicitly mentioned in terms of performance metrics. The 510(k) process typically relies on demonstration of substantial equivalence, which may involve bench testing and material characterization, but not necessarily a clinical performance study with a "standalone" algorithm in this context.
The type of ground truth used: Not applicable in the context of typical AI/diagnostic device ground truth.
The sample size for the training set: Not applicable as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable.

The document's purpose is to grant market clearance based on substantial equivalence, not to detail the results of a performance study against specific acceptance criteria.

Summary

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Image /page/0/Picture/1 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 1999

Ms. Mildred M. Goldstein President Harry J. Bosworth Company 7227 North Hamlin Avenue Skokie, Illinois 60076

K981862 Re : Trade Name: RESIN 4 Regulatory Class: II Product Code: EBI Dated: January 21, 1999 Received: January 27, 1999

Dear Ms. Goldstein:

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 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 (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. ਰੇ 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 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 not affect any obligation you might have under sections 531

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Page 2 - Ms. Goldstein

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" (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.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director

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: K981862

Device Name: RESIN 4

INDICATIONS FOR USE:

This device is for ratients requiring a heat-cured, non-cadmium pigment, containing denturi: base resin.

(PI.EASE DO NO´` WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRII, Office of Device Evaluation (ODE)

Prescription Use Use (Per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

サ

Susan Runos

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

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.