CERANUM 76 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 76 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 text describes a 510(k) premarket notification for a dental casting alloy, CERANUM 76. This submission aims to prove substantial equivalence to a legally marketed predicate device, Metalor's V-Supra Plus, rather than establishing acceptance criteria for a new device's performance through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth establishment is not applicable in this context.

Here's an breakdown of the relevant information provided:

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

In the context of a 510(k) for a material like a dental alloy, acceptance criteria are generally established by demonstrating similarity to a predicate device's characteristics and meeting recognized standards.

Characteristic	Acceptance Criteria (Predicate Device: V-Supra Plus)	Reported Device Performance (CERANUM 76)
Composition (Weight %)
Au	76.00%	76.00%
Pt	7.80%	4.00%
Pd	9.80%	10.00%
Aq	2.50%	2.97%
Cu	0.0%	2.97%
In	3.70%	3.97%
Physical/Mechanical Properties
Melting Point Range (°F)	2048-2,246	2,066-2,192
Hardness (Vickers)	230	170
Yield Strength (MPa)	540	350
Elongation (%)	10.0	13.0
CTE (x10-6/°C)	14.4	15.1

The acceptance criteria here are implicitly the values of the predicate device. The device "meets" the criteria by demonstrating sufficiently similar characteristics, even if there are some differences, as stated in the conclusion: "Despite minor differences in the materials, we believe that CERAUM 76 is a substantially equivalent to Metalor's V-Supra Plus. These changes do not affect safety or effectiveness." The submission also notes "Test methods applied: as in ANSI/ADA 5 and ISO 9693," indicating compliance with recognized standards.

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

Sample Size: Not explicitly stated as a separate "test set" in the context of a clinical study. The data presented are material properties, likely derived from laboratory testing of material samples. The exact number of samples tested to determine these averages is not provided.
Data Provenance: The data appears to originate from laboratory testing of the CERANUM 76 alloy and the predicate device (Metalor's V-Supra Plus). There is no indication of country of origin for the data or whether it is retrospective or prospective, as it's not a clinical study involving human or animal subjects.

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

This is not applicable. Ground truth, in this context, would not be established by medical experts. The "truth" for material properties is determined through standardized physical and chemical testing.

4. Adjudication method for the test set:

Not applicable. There is no adjudication method described as this is not a study involving subjective interpretations or multiple readers.

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 is a submission for a dental alloy, not an AI-powered diagnostic device, so MRMC studies and concepts of AI assistance are not relevant.

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

Not applicable. This is a material science characterization, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the material properties (composition, melting point, hardness, yield strength, elongation, CTE) is quantitative measurement data obtained through standardized laboratory testing according to ANSI/ADA 5 and ISO 9693. This is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI context, so there is no "training set."

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

Not applicable, as there is no training set.

Summary

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K023200

4 2002 NOV

510(K) SUMMARY

SB LUCIUS, INC. Submitter of 510(k): 9778 Katella Ave. Ste, 205, Anaheim, CA 92804 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 76
Common:	Dental casting alloy
Classification name:	Gold based alloys and precious metal alloys forclinical use
Product code:	EJT
Classification:	Class II

Legally marketed device: Metalor's V-Supra Plus 510(k) number: K993508

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS

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

Comparison of composition:

COMPOSITION (WEIGHT, %)

Device	Au (%)	Pt (%)	Pd (%)	Aq (%)	CU(%)	IN(%)
V-Supra Plus	76.00	7.80	9.80	2.50	0.0	3.70
CERANUM 76	76.00	4.00	10.00	2.97	2.97	3.97

Comparison of physical and mechanical properties:

Alloy	Melting PointRange (°F)	Hardness(Vickers)	Yieldstrength(MPa)	Elongation(%)	CTE(x10-6/°C)
V-Supra Plus	2048-2,246	230	540	10.0	14.4
CERANUM 76	2,066-2,192	170	350	13.0	15.1

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Discussion:

Since the composition of the leqally 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 76 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 76 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 76 is a substantially equivalent to Metalor's V-Supra Plus. These changes do not affect safety or effectiveness.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

ood and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

NOV 4:2002

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

Re: K023200

Trade/Device Name: Ceranum 76 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.

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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 (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

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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LUCIUS. INC

9778 Katella Ave

Ste-205, Anaheim, CA 92804

x : (14) 5

INDICATIONS FOR USE

11023200 510(K) Number :

Device Name(s) : ceranum 76

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)

Susan Quinn

esthesiology, General Hospital,

510(k) Number

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.