CZR PRESS LF by NORITAKE CO., INC.

I am sorry, but the provided text from the FDA 510(k) K043462 document for "CZR Press LF" porcelain powder does not contain the acceptance criteria or a study that proves the device meets specific performance criteria.

This document is a clearance letter from the FDA indicating that the device has been found substantially equivalent to a legally marketed predicate device. This type of FDA clearance does not typically include detailed performance study results or explicit acceptance criteria. Instead, it relies on demonstrating that the new device is as safe and effective as an existing, cleared device.

Therefore, I cannot fulfill your request for the following sections based on the provided text:

A table of acceptance criteria and the reported device performance: Not present in the document.
Sample size used for the test set and the data provenance: Not present in the document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present in the document.
Adjudication method: Not present in the document.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable as this is not an AI/diagnostic device. The document does not mention any MRMC studies or AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/diagnostic device.
The type of ground truth used: Not present in the document.
The sample size for the training set: Not applicable as this is not a device typically requiring a "training set" in the machine learning sense.
How the ground truth for the training set was established: Not applicable.

The document primarily states that the FDA "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 devices marketed in interstate commerce prior to May 28, 1976... and that therefore, market the device, subject to the general controls provisions of the Act."

For devices like porcelain powder, substantial equivalence is often demonstrated through material characterization, biocompatibility testing (if applicable), and comparison to the physical and chemical properties of predicate devices, rather than large-scale clinical performance studies as would be seen for diagnostic or AI-powered devices. These details are not within this specific FDA letter.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or feathers. The bird is positioned to the right of the text, which is arranged in a circular pattern around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

JAN 1 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Noritake Company, Incorporated C/O Mr. Ivan J. Wasserman, Counsel Collier Shannon Scott, PLLC Washington Harbour, Suite 400 3050 K Street NW Washington, District of Columbia 20007

Re: K043462

Trade/Device Name: CZR Press LF Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: December 14, 2004 Received: December 15, 2004

Dear Mr Wasserman:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 510(x) pic.harter is substantially equivalent (for the indications for referenced above and have delemined the ace rices marketed in interstate commerce
use stated in the enclosure) to legally market devices marketed in interstate use stated in the enclosure) to legally filanced produce Amendments, or to devices that prior to May 28, 1976, the enacthen with the provisions of the Federal Frod, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal From W have been reclassified in accordance with the provisions of the Act. The mays.
Act (Act) that do not require approval of a premarket approval applications of the general Act (Act) that do not require apploval of a prematice applo realizions of the Act. The general
therefore, market the device, subject to the general controls provisions of de therefore, market the device, subject to the senents for annon registration, listing of devices, good
controls provisions of the Act include requirements for annial registeri controls provisions of the Act mender requirements are at adulteration.
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 If your device is classified (see above) into Club Class in (erest ons affecting your device can be
may be subject to such additional controls. Existing major regulations F may be subject to such additions, Title 21, Parts 800 to 89%. In addition, FDA may publish
found in the Code of Federal Regulations, Title 21, Parts 800 to 89%. In additio found in the Code of Federal reegalament, your device in the Federal Register.

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Page 2 - Mr. Ivan J. Wasserman, Esq.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualled of a solenice complies with other requirements of the Act or that FDA made a decemination max your ced by other Federal agencies. You must comply with ally rederal statutes and regulations abut not limited to: registration and listing (21 CFR Part 807); all the Act s requirements, monacturing practice requirements as set forth in the quality labeling (21 CFR Part 001), good management of any from 11 case on one product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product Systems (QD) 105-105-131-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin maneting your antial equivalence of your device to a legally premarket nothleation: "The FDA midning of backanse of 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 If you desire specific advice ion your ac now to 2011-01-11 5. Also, please note the regulation entitled, comact the Office of Comphance at (210) 27 of CFR Part 807.97). You may obtain other Misoraliums of reference to promaibilities under the Act from the Division of Small general intornation on your responsionnes 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,

Carl S. Luip, Ph.D.

Chiu S. Lin, PhD 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

1043462 510(k) Number (if known):

Device Name: CZR Press LF

Indications For Use:

For use in prosthetic dentistry to create an all-ceramic prosthesis

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Syoom Russe

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

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Kouzyler 510(k) Number:_

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.