MIRACLE 98 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for single unit with lower fusing porcelains and indirect restorative composites. MIRACLE 98 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 request is to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

Based on the provided 510(k) summary for the "MIRACLE 98" dental casting alloy, the device is a Class II device (Gold-based alloys and precious metal alloys for clinical use). The approval is based on substantial equivalence to a predicate device, Heraeous Kulzer's Jel Bios Pure (K002645), rather than a clinical study with acceptance criteria in the typical sense of a diagnostic or AI device.

Here's the information formatted as requested, with "N/A" where the information is not applicable to this type of device and submission:

Acceptance Criteria and Device Performance for MIRACLE 98 (K031010)

This submission relies on demonstrating substantial equivalence to a legally marketed predicate device (Heraeous Kulzer's Jel Bios Pure, K002645) by comparing material composition and physical/mechanical properties. The "acceptance criteria" are implied by the similarity of these characteristics to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Property	Acceptance Criteria (Predicate: Jel Bios Pure)	Reported Device Performance (MIRACLE 98)	Pass/Fail
Composition (Weight %)
Au (%)	99.30	97.60	Pass
Pt (%)	<1.0	2.1	Pass
In (%)	<1.0	<1.0	Pass
Zn (%)	<1.0	<1.0	Pass
Physical & Mechanical Properties
Melting Point Range (°F)	1,900-2,010	1,904-2,015	Pass
Hardness (Vickers)	50	45	Pass
Yield Strength (psi)	55,000	54,000	Pass
Elongation (%)	45.0	50.0	Pass
CTE (x10-6/°C)	15.3	15.1	Pass
Density (g/cm3)	19.2	19.2	Pass

Note: The "Pass" determination is based on the submitter's conclusion that "The main elements and their concentration are almost identical" and "Despite minor differences in the materials, we believe that MIRACLE 98 is a substantially equivalent to Heraeous Kulzer's Jel Bios Pure. These changes do not affect safety or effectiveness." The FDA concurred with this assessment in their letter.

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

Sample Size: N/A for a clinical or diagnostic test set. The data consists of reported material properties for a specific formulation of the alloy. It is a comparison of two material specifications, not a test on a "test set" of patients or cases.
Data Provenance: N/A in the typical sense. The properties are likely derived from laboratory testing of the alloy materials, as per ANSI/ADA 5 and ISO 9693 standards. The country of origin for the data is not specified, but the submitter is SB LUCIUS, INC. (Anaheim, CA, USA). The data is not retrospective or prospective in the clinical study context.

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

Number of Experts: N/A. Ground truth for material properties is established through standardized laboratory testing and chemical analysis, not expert interpretation of results in a clinical setting.
Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

Adjudication Method: N/A. There is no "test set" requiring expert adjudication. The comparison is based on objective material specifications and test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

MRMC Study: No. This is a material science submission, not a diagnostic imaging or AI device.

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

Standalone Performance: No. This is a dental material, not an algorithm or AI device.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" here is the scientifically determined chemical composition and physical/mechanical properties of the alloy materials, as measured according to recognized industry standards (ANSI/ADA 5 and ISO 9693).

8. The Sample Size for the Training Set

Training Set Sample Size: N/A. This is a material device; there is no "training set" in the context of machine learning.

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

Ground Truth Establishment for Training Set: N/A.

Summary

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K03/010

JUN 2 5 2003 510(K) SUMMARY

Submitter of 510(k):

SB LUCIUS, INC.

9778 Katella Ave. 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:	March. 26, 2003
Trade name:	MIRACLE 98
Common:	Dental casting alloy
Classification name:	Gold based alloys and precious metal alloys for clinical use
Product code:	EJT
Classification:	Class II

Legally marketed device: Heraeous Kulzer's Jel Bios Pure 510(k) number: K002645

SJMMARY OF THE TECHNOLOGICAL CHARACTERISTICS

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

Comparison of composition:

COMPOSITION (WEIGHT)

Device Name	Au (%)	Pt (%)	In (%)	Zn (%)
Jel Bios Pure	99.30	<1.0	<1.0	<1.0
Ceranum 98	97.60	2.1	<1.0	<1.0

Comparison of physical and mechanical properties:

Alloy	Melting PointRange (°F)	Hardness(Vickers)	YieldStrength(psi)	Elongation(%)	CTE(x10-6/°C)	Density(g/cm3)
Jel Bios Pure	1,900-2,010	50	55,000	45.0	15.3	19.2
Miracle 98	1,904-2,015	45	54,000	50.0	15.1	19.2

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Discussion:

Sirice 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. MIRACLE 98 is a High Noble, Micro-fine, Yellow, Gold based alloy to be used for single unit with lower fusing porcelains and indirect restorative composites. MIRACLE 98 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 MIRACLE 98 is a substantially equivalent to Heræous Kulzer's "el Bios Pure". These changes do not affect safety or effectiveness.

Statement of indication for use: MIRACLE 98 is intended for manufacturing:

Porcelain to metal fabrication of single units

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three wavy lines, which are meant to represent the human form.

Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 2003

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

Re: K031010

Trade/Device Name: MIRACLE 98 Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: March 26, 2003 Received: March 31, 2003

Dear Ms. 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.

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Page 2 - Ms. Chang

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); 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Ruane

Susan Runner, DDS, MA Interim 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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SB LUCIUS,INC. 9778 Katella Ave. Ave. Ste 205, Anaheim, CA 92804

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

INDICATIONS FOR USE

510(K) Number : K031010

[Device Name(s) : MIRACLE 98

MIRACLE 98 is intended for manufacturing :

Porcelain to metal fabrication of single units

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

text

CONCURRENCE OF CHRD,OFFJCE OF VICE EVALUATION(OED)

. General H

510(k) Number: K 031012

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.