CERANUM 90 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 90 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

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the CERANUM 90 device, structured to answer your specific questions.

In this 510(k) summary, the device is a dental casting alloy, and the "study" is a comparison to a legally marketed predicate device, not a typical diagnostic or AI-based study. As such, some of your requested categories (like MRMC studies, training set, or expert adjudication for image ground truth) are not applicable.

Acceptance Criteria and Device Performance for CERANUM 90

1. Table of Acceptance Criteria and Reported Device Performance

Property	Acceptance Criteria (Predicate: Jel Bios 90)	Reported Device Performance (Ceranum 90)
Composition (Weight %)
Au	90.00	90.00
Pt	7.40	4.00
Pd	-	11.95
Ag	1.0	0.05
Cu	-	0.2
Sn	-	0.40
Fe	<1.0	0.15
Zn	<1.0	1.00
Physical and Mechanical Properties
Melting Point Range (°F)	1,920-2,085	2,012-2,102
Hardness (Vickers)	160.0	145.7
Yield Strength (MPa)	386	255
Elongation (%)	8.0	16.76
CTE (x10-6/°C)	14.6 No explicit "criteria", comparison values only.	15.03
Density (g/cm³)	18.8 No explicit "criteria", comparison values only.	19.25

Acceptance Criteria Interpretation: For this type of device, "acceptance criteria" are implied by demonstrating substantial equivalence to a legally marketed predicate device (Jel Bios 90). The expectation is that the new device's composition, physical, and mechanical properties are sufficiently similar or superior such that the device is as safe and effective as the predicate. The document highlights that the "main elements and their concentration are almost identical" in composition, and provides a direct comparison of physical/mechanical properties.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable in the context of a typical clinical test set for a diagnostic device. This submission is based on material property testing and chemical composition analysis of the CERANUM 90 alloy itself, compared to the specifications of the predicate alloy. The quantity of material tested to obtain these properties is not specified but would follow standard material testing protocols (e.g., ANSI/ADA 5 and ISO 9693).
Data Provenance: The data is generated from testing of the CERANUM 90 alloy, implying a prospective testing approach where the manufacturer performed tests on their own product. The country of origin of the data is not specified, but the manufacturer is SB Lucius, Inc. based in Anaheim, CA, USA, so testing likely occurred in the US or a qualified international lab.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. Ground truth, in this context, refers to the accurately measured properties of the alloy, established through standardized material testing methods (ANSI/ADA 5 and ISO 9693), not through expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. There is no human adjudication for material property measurements. The results are quantitative and objective based on defined test methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images, which is not the case for a dental casting alloy.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a material, not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this submission consists of:
- Chemical Composition: Determined by analytical chemistry techniques.
- Physical and Mechanical Properties: Determined by standardized material testing methods (e.g., melting point, hardness, yield strength, elongation, CTE, density) as specified by ANSI/ADA 5 and ISO 9693.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/machine learning device. The material properties are inherent to the alloy's formulation and manufacturing process.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set. The properties of the CERANUM 90 alloy are established through direct measurement and adherence to manufacturing specifications.

Summary

{0}------------------------------------------------

1 2002 NOV

K023198

510(K) SUMMARY

Submitter of 510(k): SB LUCIUS, INC. Ste.205, Anaheim, CA 92804 9778 Katella Ave. Phone: (714) 530-2814, Fax : (714) 530-3448,

Contact person:	Dae-Kyu Chang
Phone:	(714) 530-2814
Fax:	(714) 530-3448
E-mail:	Gatorkr@yahoo.co.kr
Date of Summary:	Sept. 16, 2002
Trade name:	CERANUM 90
Common:	Dental casting alloy
Classification name:	Gold based alloys and precious metal alloys forclinical use
Product code:	EJT
Classification:	Class II

Legally marketed device: Jel Bios 90 510(k) number: K001196

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS

Test methods applied: as in ANSI/ADA 5 and ISO 9693

Comparison_of composition:

Device Name	Au	Pt	Pd	Ag	CU	Sn	FE	Zn
Jel Bios 90	90.00	7.40	-	1.0	-	-	<1.0	<1.0
Ceranum 90	90.00	4.00	11.95	0.05	0.2	0.40	0.15	1.00

COMPOSITION (WEIGHT %)

Comparison of physical and mechanical properties:

Alloy	Melting PointRange (°F)	Hardness(Vickers)	YieldStrength(MPa)	Elongation(%)	CTE(x10-6/°C)	Density(g/cm3)
Jel Bios 90	1,920-2,085	160.0	386	8.0	14.6	18.8
Ceranum 90	2,012-2,102	145.7	255	16.76	15.03	19.25

{1}------------------------------------------------

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 90 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 90 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 CERANUM 90 is a substantially equivalent to J.F.JELENKO's Jel Bios 90. These changes do not affect safety or effectiveness.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. In the center of the seal is a stylized image of an eagle with its wings spread. The eagle is facing to the right. The image is black and white.

d and Drug Administration Corporate Boulevard ckville MD 20850

Mr. Dae-Kyu Chang SB Lucius, Incorporated 9778 Katella Avenue, Suite 205 Anaheim, California 92804

Re: K023198

Trade/Device Name: Ceranum 90 Regulation Number: 21 CFR 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: September 16, 2002 Received: September 25, 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.

{3}------------------------------------------------

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 (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 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 Internet address http://www.fda.gov/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

{4}------------------------------------------------

9778 Katella Ave

Ste. 205, Anaheim, CA 92804

Phone: (714) 530-2814,
Fax : (714) 530-3448,

INDICATIONS FOR USE

510(K) Number : ______________________________________________________________________________________________________________________________________________________________

Device Name(s) : ceranum 90

This is a yellow ceramic alloy for single units, implants prosthetics, single & 3/4 crowns, and short span bridges.

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

CONCURRENCE OF CHRD,OFFICE OF DEVICE EVALUATION(OED)

Suvir Rana

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

510(k) Number. K(i) RAn

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.