Refractron Porcelain Powder Blanks are high purity, bisque fired zirconia machining blanks. The powders pressed to form these blanks are of a uniform size and well dispersed, ensuring no agglomerates. The resultant fine-grained, bisque body allows intricate shapes to be machined with specified tolerances. Refractron Technologies Corporation Blanks (exactly Zircar Zirconia, Inc. Blanks) are dental ceramic blanks designed for the manufacturing of substructures for ceramic dental appliances. The dental appliance is machined either by CAD/CAM machining or using the copying technique. Products are either porous or dense. Porous blanks can then be sintered to full density and strength. Dense blanks do not need a final heat treatment and are therefore ready for veneering immediately after machining. All appliances are for the sole use of the particular patient only. At the dental lab (Refractron's customer that processes the blanks) a metal chuck is glued on the end of the blank that holds it in the CAD/CAM machine which is used to machine the final dental restoration. At the completion of the machining steps, the dental restoration is fired, i.e. sintered, in the oven to harden the ZrQ2.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, specifically Refractron Bisque Zirconia Blanks. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria through clinical trials.

The document explicitly states: "The Refractron Bisque Zirconia Blank is substantially equivalent in function and intended use to the Zircar Zirconia, Inc. Bisque Zirconia Blanks - K081850." and "It has been shown in this pre-market notification submission, that the differences between the Refractron Porcelain Powder Blanks and the Zirconia Blanks do not raise any questions regarding their safety and effectiveness. They are, as explained below, the same product."

Therefore, the information typically requested in your prompt (such as acceptance criteria, reported device performance metrics from a study, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not present in this type of regulatory submission because it's not a de novo clearance or a PMA where such detailed performance studies are usually required. The "study" here is essentially a comparison to a predicate device to show identical or very similar characteristics and performance.

Here's a breakdown based on the information that is available in the provided text:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: The primary "acceptance criterion" for a 510(k) is substantial equivalence to a predicate device. This means demonstrating that the new device has the same intended use and technological characteristics as a predicate, or if there are differences, that those differences do not raise new questions of safety or effectiveness.
Reported Device Performance: The document asserts that "The Refractron Porcelain Powder Blanks, as designed and manufactured, are as exactly safe and effective as the predicate device and therefore are determined to be substantially equivalent to the referred predicate device. They are in fact, one-in-the same." No specific performance metrics (e.g., strength, durability, fit) are reported in a quantifiable table within these pages; rather, it's a qualitative statement of equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not Applicable. This document does not describe a clinical or performance study with a test set of data. The submission relies on demonstrating the material properties and manufacturing process are equivalent to the predicate, which itself would have undergone testing previously.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not Applicable. As there is no clinical or performance test set described, there are no experts establishing ground truth for such a set within this document. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. No test set or need for adjudication is mentioned.

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:

Not Applicable. This device is a dental material, not an AI-assisted diagnostic tool, so MRMC studies are irrelevant.

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

Not Applicable. This is a physical dental material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" implicitly relied upon is the established safety and effectiveness profile of the predicate device (Zircar Zirconia, Inc. Bisque Zirconia Blanks - K081850), as determined by previous FDA clearance processes. The current submission argues that the Refractron blanks are identical or sufficiently similar to this predicate, meaning no new safety or effectiveness concerns are raised.

8. The sample size for the training set:

Not Applicable. No training set for a machine learning algorithm is involved.

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

Not Applicable. No training set for a machine learning algorithm is involved.

In summary, this document is a 510(k) Premarket Notification focused on demonstrating substantial equivalence to an existing predicate device rather than presenting performance data from a novel study against specific acceptance criteria.

Summary

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SEP 1 0 2009

K09/852

Refractron Technology Corporation (Pre-market Notification)

Page 14

Appendix A (Summary of Safety And Effectiveness)

Submitter:

John Gagliardi, President (contact person) and official correspondent for RTC) MidWest Process Innovation, LLC 7736 Woodside Court Maineville, OH 45039 513-573-0085 (Telephone and fax) or 513-573-0519 (Telephone and fax) JGAGL777@One.Net

Trade Name: Refractron Technologies Corporation Bisque Zirconia Blanks

Common Name: Refractron Technology Corporation Bisque Zirconia Blanks

Classification Name: Porcelain Powder for Clinical Use

Summary of Safety and Effectiveness:

The Refractron Bisque Zirconia Blank is substantially equivalent in function and intended use to the Zircar Zirconia, Inc. Bisque Zirconia Blanks - K081850. This predicate device is presently on the market.

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. As such, it has been shown in this pre-market notification submission, that the differences between the Refractron Porcelain Powder Blanks and the Zirconia Blanks do not raise any questions regarding their safety and effectiveness. They are, as explained below, the same product

The Refractron Porcelain Powder Blanks, as designed and manufactured, are as exactly safe and effective as the predicate device and therefore are determined to be substantially equivalent to the referred predicate device. They are in fact, one-in-the same.

Note: Zircar Zirconia Blanks (the predicate device designated for this Pre-Market Notification submitted by Refractron Technologies Corporation, Newark, NY are actually, on a day-to-day basis, produced for Zircar Zirconia, Inc., PO Box 287, Florida, NY 10921-0287, i.e. the actual Bisque Zirconia Blanks so mentioned in K081850 are a product manufactured by Refractron Technologies Corporation for Zircania, Inc. Zircar Zirconia, Inc. has only one supplier for these blanks. i.e. Refractron Technologies Corporation.

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SEP 1 0 2009

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

Refractron Technologies, Incorporated C/O Mr. John Gagliardi President MidWest Process Innovation, L.L.C. 7736 Woodside Court Maineville, Ohio 45039

Re: K091852

Trade/Device Name: Bisque Zirconia Blanks RG10191, RG10210, RG10211, and RG10205

Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: June 19, 2009 Received: June 23, 2009

Dear Mr. Gagliardi:

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 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. Gagliardi

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

Susan Tanner

Susan Runner, D.D.S., M.A. Acting Division 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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Refractron Technologies Corporation Pre-market Notification

Page 5

1071

INDICATIONS FOR USE

510(k) Number (if known): Not known at this time.

Classification Name: Porcelain Powder For Clinical Use

Device Name: Refractron Technologies Corporation Bisque Zirconia Blanks

Indications for Use: Refractron Technologies Corporation Bisque Zirconia Blanks (Type BYZ), are indicated for use as a substructure for ceramic dental restorations.

Sizes: Various sizes and shapes, e.g. rectangular, disk-shaped, square, etc. and similar to the sizes mentioned in K081850

Prescription Use Only: All blanks are sold by or on the order of a dental X professional. They are not for use by the general public or over the counter (OTC).

Per Part 21 CFR 801, Subpart D

(Please Do Not write below this line-continue on another page as needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

of Page

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

510(k) Number: K091852

K091852 Susan Fox

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

510(k) Number: K

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.