SILKLINE SOFT RELINING KIT, MODEL 28-100100 by J. MORITA USA, INC.

The provided text is a 510(k) premarket notification letter from the FDA regarding a dental device called "SilkLine Soft Relining Kit." This document does not describe acceptance criteria for a device, nor does it detail a study that proves the device meets such criteria.

The information provided is a clearance letter from the FDA indicating that the device has been found substantially equivalent to a legally marketed predicate device. This process, known as 510(k) clearance, is primarily about demonstrating equivalency to existing devices, not about establishing specific performance metrics against pre-defined acceptance criteria through a clinical study as would be detailed for a novel device or AI-powered system.

Therefore, I cannot provide the requested information as it is not present in the given text.

To address the specific points you requested:

A table of acceptance criteria and the reported device performance: Not available in the text.
Sample size used for the test set and the data provenance: Not available in the text.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in the text.
Adjudication method: Not available in the text.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not available in the text. This type of study is more common for diagnostic AI devices, not for a dental relining kit.
If a standalone performance study was done: Not available in the text.
The type of ground truth used: Not applicable for this type of device clearance and not mentioned.
The sample size for the training set: Not applicable (no AI/algorithmic training mentioned).
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the top half of the circle. The bottom half of the circle contains a stylized image of three human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 2006

J. Morita USA, Incorporated Mr. Howard Rowe Consultant 9 Mason Irvine, California 92618

Re: K060844

Trade/Device Name: SilkLine Soft Relining Kit Regulation Number: 872.3760 Regulation Name: Denture Relining, Repairing or Rebasing Resin Regulatory Class: II Product Code: EBI Dated: March 24, 2006 Received: March 28, 2006

Dear Mr. Rowe:

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. Rowe

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 (240) 276-0115. 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/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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 (if known):	Not Assigned to date K060844
Device Name:	SilkLine Soft Relining Kit

Indications For Use:

The SilkLine Soft Relining Kit is intended to be used as a denture relining, repairing, or rebasing resin.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
OR (Per 21 CFR 801.109)
Over-The-Counter Use

Sign Here

of Anesthesiology, General Hospital,
Lion Control, Dental Devices

K Number:	K060841
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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.