AIGIS-PLUS is an inlay, onlay, crown and bridge alloy. This device is dependable 56% gold alloy with a high gold appearance. AIGIS-PLUS is excellent for inlays, three-quarter crowns, long and short-span bridges.

AI/ML Overview

This 510(k) summary describes a dental casting alloy, AIGIS-PLUS, and aims to demonstrate its substantial equivalence to a legally marketed predicate device, ARGENCO 56. The study focuses on comparing the physical and mechanical properties and composition of the two alloys.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document. Instead, the "acceptance criteria" are implied by the comparison to the predicate device, ARGENCO 56. The device is considered to meet acceptance criteria if its properties are "very similar" or "almost identical" to the predicate, with "minor differences" that "do not affect safety or effectiveness."

Property	Acceptance Criteria (Predicate: ARGENCO 56)	Reported Device Performance (AIGIS-PLUS)
Composition (Weight %)	- Main elements and their concentration	- Main elements and their concentration are almost identical
Melting Point Range (°F)	1,600-1,710	1,690-1,742
Hardness (Vickers)	186	154
Yield Strength (MPa)	372	300
Elongation (%)	38	15
Density (g/cm³)	13.6	13.7

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

This document does not specify a separate "test set" in the context of typical algorithm validation. The "study" here is a comparison of material properties.

Sample Size: Not explicitly stated. The table presents single values for each property, implying these are average or representative values obtained from testing unspecified sample sizes of both ARGENCO 56 and AIGIS-PLUS.
Data Provenance: Not explicitly stated. It is implied that the data for AIGIS-PLUS was generated by the submitter (SB Lucius, Inc.) through their own testing, as they are providing this information for their new device. The data for ARGENCO 56 would presumably be from its existing regulatory submission or published material data. The country of origin for the data is not mentioned, but the submitter is based in Anaheim, CA, USA. The study is retrospective in the sense that the predicate device's data is pre-existing; the testing of AIGIS-PLUS to generate its performance data would be prospective.

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

Not applicable. This is not a study involving expert review for establishing ground truth, but rather a materials science comparison. The "ground truth" here is the measured physical and mechanical properties of the alloys.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as it's not and expert-based review. The comparison is based on objective measurements against a predicate device.

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 not a diagnostic device or an AI-enabled device. It is a dental casting alloy.

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

Not applicable. This is not an algorithm or AI-enabled device.

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

The "ground truth" for this study is based on standardized materials testing of the physical and mechanical properties of the dental alloys, as described by "Test methods applied: as in ANSI/ADA 5 and ISO 9693." These standards define the procedures for measuring properties like melting point, hardness, yield strength, elongation, and density.

8. The sample size for the training set

Not applicable. There is no training set for this type of material comparison study.

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

Not applicable, as there is no training set.

Summary

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MAR 1 0 2003

K024135

510(K) SUMMARY

Submitter of 510(k): SB LUCIUS, INC. 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

Dec 15, 2002 Date of Summary:

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

Legally marketed device: ARGENCO 56 510(k) number: K893568

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS

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

Comparison of composition:

COMFUSHIUN (WEIGHT, %
Cevice Name	16				R/In
ARGENCO50	VIV			ﻟﻠﺘﻌﻠﻴﻤﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
AIGIS "	10.6	05	ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ

COMPOSITION (WEIGHT %)

Comparison of physical and mechanical properties:

Alloy	Melting Point Range (°F)	Hardness(Vickers)	YieldStrength(MPa)	Elongation(%)	Density(g/cm3)
ARGENCO 56	1,600-1,710	186	372	38	13.6
AIGIS-PLUS	1,690-1,742	154	300	15	13.7

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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.

Coriclusion:

The main elements and their concentration are almost identical. AIGIS-PLUS is an inlay, onlay, crown and bridge alloy. This device is dependable 56% gold alloy with a high gold appearance. AIGIS-PLUS is excellent for inlays, three-quarter crowns, long and short-span bridges. AIGIS-PLUS is substantially equivalent to ARGENCO 56 and the minor differences between them do not affect safety or effectiveness.

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Image /page/2/Picture/1 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract human profiles facing right, with flowing lines suggesting movement or connection. The profiles are stacked vertically, creating a sense of depth and unity.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2003

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

Re: K024135

Trade/Device Name: AIGIS-PLUS Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: December 15, 2002 Received: December 16, 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.

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Page 2 - Mr. 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 (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), 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 Runore

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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SE LUCIUS,INC. 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) : AIGIS-PLUS

AIGIS-PLUS is intended for manufacturing

Inlay / Onlays …
Crowns -
Short span bridges -
Long span bridges -
Removable partials -

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

CONCURRENCE OF CHRD,OFFICE OF DEVICE EVALUATION(OED)

Me advh ta MSR

nesthesiology, General Hospital, Infection Control, Dental Devic

510(k) Number.__K

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.