Zirconia Blanks are dental materials (semi finished products) made of presintered zirconium dioxide for milled production of crowns and bridges frameworks on commercial CAD/CAM systems or hand operated copymilling machines, with outstanding biocompatibility and high resistance against tension and pressure. In its pre-sintered condition the product is excellently suitable for preparing dental prostheses(crowns, bridges, superstructures, inlays and olays) produced by manual and machine milling technique.

AI/ML Overview

This document does not describe an AI/ML device, nor does it describe a study to prove acceptance criteria that would include the information requested (such as sample size for test/training sets, expert qualifications, adjudication methods, or MRMC studies).

The document is a 510(k) summary for a dental device called "Zircostar (zirconia blanks)". It details the device's intended use, comparison to a predicate device, and non-clinical testing performed.

Here's the information that can be extracted from the provided text, related to the initial request for acceptance criteria and device performance, but framed within the context of non-clinical testing for a traditional medical device, not an AI/ML-driven one:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Standard Reference)	Reported Device Performance
Mechanical Testing	ISO 6872:2008 (Specific parameters not detailed)	Passed all tests
Material Analysis	(Not detailed)	Passed all tests
Biocompatibility	(Not detailed)	Passed all tests

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified for any of the non-clinical tests.
Data Provenance: Testing was performed by "third-party laboratories." The document doesn't specify countries of origin for the data or if it was retrospective/prospective, as these terms are not applicable to the non-clinical material and mechanical tests described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. For this type of traditional medical device, "ground truth" as typically defined for AI/ML models (e.g., expert consensus on images) is not relevant. The "ground truth" here is adherence to established engineering and material science standards (e.g., ISO 6872:2008) in laboratory conditions.

4. Adjudication method for the test set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review in clinical or image-based studies. For non-clinical material testing, the "adjudication" is inherent in whether the measured mechanical and material properties meet the specified values in the relevant ISO standard.

5. 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:

No. An MRMC study was not conducted as this is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is not an AI/ML device, so a standalone algorithm performance study is not applicable.

7. The type of ground truth used:

Engineering and Material Science Standards: The "ground truth" was based on adherence to voluntary design standards, specifically ISO 6872:2008 for non-clinical testing, and general material analysis and biocompatibility standards. These standards define acceptable performance thresholds for dental materials.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device; therefore, there is no "training set."

9. How the ground truth for the training set was established:

Not applicable. There is no training set for this device.

Summary Conclusion from the Document:

The device, Zircostar (zirconia blanks), was deemed substantially equivalent to its predicate device (Dental Direct DD Bio Z, DD Bio Z-transpa) based on:

Identical intended use.
Similar technological characteristics.
Successful completion of non-clinical mechanical testing, material analysis, and biocompatibility tests against company specified design requirements and the voluntary design standard ISO 6872:2008.
No clinical testing was performed or relied upon to determine substantial equivalence.

Summary

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Exhibit #1

K120852

510(K) SUMMARY

JUN - 6 2012

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

Date Prepared: March 16, 2012

1. Applicant: Mr. Fényi Balázs Kerox Ltd. H-2049 Diosd, Homokbanya ut 77. Hungary
  Phone: (36 23) 382 006, ext-105

Fax: 36 23 545 158 EMAIL: balazs.fenyi@keroxdental.net

2. Submitter:

Mr. Sangram Yadav Official Correspondent for Kerox Ltd mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021

TEL: 516-482-9001 FAX: 516-482-0186

EMAIL:sangram@mdiconsultants.com

Name of the Device: 3.

Zircostar (zirconia blanks)

Common or Usual Name and Classification: 4.

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Porcelain powder for clinical use. Regulation number: 872.6660 Product Code EIH

Predicate Device Information: ડ.

Dental Direct DD Bio Z, DD Bio Z-transpa 510k number: (K093748)

Device Description : 6.

In its pre-sintered condition the product is excellently suitable for preparing dental prostheses(crowns, bridges, superstructures, inlays and olays) produced by manual and machine milling technique.

7. Intended Use

Zirconia Blanks are indicated for crowns, multi-unit bridges and inlay bridges Applications include both anterior and posterior bridges.

Comparison to Predicate Devices: 8.

The Zircostar (Zirconia blank) is substantially equivalent to the Dental Direct DD Bio Z, DD Bio Z-transpa the predicate device in intended use, operation, safety and function.

1. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

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Mechanical testing, Material analysis and biocompatibility tests were performed by third party laboratories. The device passed all tests.

10. Clinical Testing:

Kerox Ltd. did not conduct clinical tests to determine substantial equivalence.

11. Non Clinical Testing:

Kerox dental did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Non-clinical testing was performed in order to validate the design against the company's specified design requirements, and to assure conformance with the following voluntary design standard: ISO 6872:2008.

Risk Management:

The device has been designed to either completely eliminate or mitigate known health hazards associated with the use of the device. Health hazard risk reduction has been accomplished by rigorous

Application of a risk management program according to ISO 14971 "Medical devices - Application of risk management to medical devices".

Technological characteristics:

The technological characteristics between the predicate and proposed devices are identical. There is no difference in fundamental scientific technology. They have the same intended use.

· 12. Conclusion:

Kerox Ltd believes that Zircostar (Zirconia blank) is as safe and effective as the predicate device when used as instructed by knowledgeable and trained personnel, and are substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the logo. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN - 6 2012

Kerox Limited C/O Mr. Sangram Yadav Official Correspondent MDI Consultants. Incorporated 55 Northern Blvd., Suite 200 Great Neck, New York 11021

Re: K120852

Trade/Device Names: Zircostar Zirconia Blanks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: May 30, 2012 Received: May 31, 2012

Dear Mr. Yadav:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Eederal Register.

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Page 2 - Mr. Yadav:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. 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

K120852

510(k) Number (if known):

Device Name: Zirconia Blanks (Zircostar)

Indications for Use:

Zirconia Blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.

AND/OR Prescription Use X (Per 21CFR 801 Subpart D)

Over-The-Counter Use (21CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

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

510(k) Number: K120852

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.