CERANUM 87 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for inlays, onlays, single crowns, bridge, implant superstructures and substrate for medium expansion with lower fusing porcelains and indirect restorative composites. CERANUM 87 is a high gold ceramic alloy, which heightens the porcelain esthetics of the restoration and provides strength, durability and color of gold.

AI/ML Overview

The provided document, KO21947, is a 510(k) premarket notification for a dental casting alloy named CERANUM 87. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies to evaluate device performance against specific acceptance criteria in the same way a diagnostic AI device would.

Therefore, many of the requested elements for a clinical study on AI device performance are not applicable to this document. The document describes a comparison of physical and chemical properties of a dental alloy, not a clinical study involving human patients or complex performance metrics for a diagnostic device.

Here's a breakdown based on the provided document and the nature of a 510(k) for a dental alloy:

A table of acceptance criteria and the reported device performance

There isn't a direct "acceptance criteria" table for a diagnostic AI device's performance in the clinical sense. Instead, the "acceptance criteria" can be inferred from the comparison of the CERANUM 87 alloy's properties to those of the predicate device, DEGUDENT GS. The implicit acceptance criterion is that the new device's properties are "substantially equivalent" to the predicate.

Property	Acceptance Criteria (Predicate: Degudent GS)	Reported Device Performance (Ceranum 87)
Composition (Weight)
Au (%)	86.00	86.95
Pt (%)	9.70	8.87
Pd (%)	2.20	1.15
In (%)	2.0	1.0
Physical/Mechanical Properties
Melting Point Range (°F)	1,949-2,174	2,008-2,079
Hardness (Vickers)	155	150
Yield Strength (psi)	58,000	53,600
Elongation (%)	8.0	9.0
CTE (x10-6/°C)	14.4	13.4
Density (g/cm3)	18.5	18.6

*Implicit Acceptance Criterion*: The values for CERANUM 87 are considered "almost identical" or within a range that does not affect safety or effectiveness, leading to a determination of substantial equivalence. The document states: "The main elements and their concentration are almost identical." and "Despite minor differences in the materials, we believe that CERAUM 87 is a substantially equivalent to DEGUSSA AG's DEGUDENT GS. These changes do not affect safety or effectiveness."

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

*   **N/A.** This is a comparison of alloy properties based on standard test methods (ANSI/ADA 5 and ISO 9693), not a clinical study with a patient test set. The "samples" would refer to tested batches of the alloy, not a patient population. Data provenance (country of origin, retrospective/prospective) is not mentioned as it's not relevant for this type of submission.

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)

*   **N/A.** Ground truth in the context of diagnostic performance is not applicable here. The "ground truth" for material properties is established by the results of the standardized physical and mechanical tests themselves.

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

*   **N/A.** No adjudication method is described or required for this type of material property comparison.

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

*   **N/A.** This is not a diagnostic AI device, so no MRMC study or assessment of human reader improvement is relevant.

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

*   **N/A.** Not an AI algorithm.

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

*   **Material Property Standards/Test Results.** The "ground truth" related to the device's characteristics are the quantitative measurements of its physical and mechanical properties, as determined by applying recognized industry standards like ANSI/ADA 5 and ISO 9693.

8. The sample size for the training set

*   **N/A.** This is not an AI/machine learning device, so there is no training set.

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

*   **N/A.** Not an AI/machine learning device.

Summary

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KO21947

AUG 2 6 2002

510(K) SUMMARY

Submitter of 510(k): Lucius Metals Com. 4241 Farquhar Ave. #2, Los Alamitos, CA 90720 Phone/Fax: (562) 799-6626, Cell: (562) 477-0155

Contact person:	Dae Kyu Chang
Phone:	(562) 799-6626
Fax:	(562) 799-6626
E-mail:	Gatorkr@yahoo.co.kr

Date of Summary: June 5, 2002

Trade name:	CERANUM 87
Common:	Dental casting alloy
Classification name:	Gold based alloys and precious metal alloys forclinical use
Product code:	EJT
Classification:	Class II

Legally marketed device: DEGUDENT GS 510(k) number: K905387

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS Test methods applied: as in ANSI/ADA 5 and ISO 9693

Comparison of composition:

COMPOSITION (WEIGHT)
	Au (%)	Pt (%)	Pd (%)	In (%)
Degudent GS	86.00	9.70	2.20	2.0
Ceramum87	86.95	8.87	1.15	1.0

POSITION MICICUTY

Comparison of physical and mechanical properties:

Alloy	Melting PointRange (°F)	Hardness(Vickers)	YieldStrength(psi)	Elongation(%)	CTE(x10-6/°C)	Density(g/cm3)
DegudentGS	1,949-2,174	155	58,000	8.0	14.4	18.5
Ceranum87	2,008-2,079	150	53,600	9.0	13.4	18.6

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Discussion:

Since the composition of the legally marketed alloy and the new device is very similar, it may be assumed that the biological compatibility of the alloys is also very similar.

Conclusion:

The main elements and their concentration are almost identical. CERANUM 87 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for inlays, onlays, single crowns, bridge, implant superstructures and substrate for medium expansion with lower fusing porcelains and indirect restorative composites. CERANUM 87 is a high gold ceramic alloy, which heightens the porcelain esthetics of the restoration and provides strength, durability and color of gold. Despite minor differences in the materials, we believe that CERAUM 87 is a substantially equivalent to DEGUSSA AG's DEGUDENT GS. These changes do not affect safety or effectiveness.

Statement of indication for use: CERANUM 87 is intended for manufacturing:

-Inlay / Onlays
-Crowns
Bridges -
-Implant superstructures

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract image of an eagle or bird, with three stylized lines forming the body and wings.

AUG 2.6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Dae-Kyu Chang Manager Lucius Metals Com. 4241 Farquhar Avenue, #2 Los Alamitos, California 90720

Re: K021947

Trade/Device Name: CERANUM 87 Regulation Number: 872.3060 Regulation Name: Gold-based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: June 5, 2002 Received: June 13, 2002

Dear Mr. Chang:

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.

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.

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Page 2 – Mr. Chang

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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613 . 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 Internetaddress http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski

Timothy A. Ulatowski 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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Koz1947

STATEMENT OF INDICATION FOR USE

CERANUM 87 is intended for manufacturing:

Inlay / Onlays ・
Crowns -
Bridges -
Implant superstructures -

Robert Spetz DDS for Dr. Susan Sumner

(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital,
Division Ocetrol, Deptal Devices Division of Anesthoolors.org
Infection Control, Dental Devices

510(k) Number: K021947

Regulation Number and Section

§ 872.3060 Noble metal alloy.

(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.