AIGIS-SOFT is an inlay, onlay, crown and bridge alloy. This device is dependable 83% gold alloy with a high gold appearance. AIGIS-SOFT is excellent for inlays, three-quarter crowns, long and short-span bridges.

AI/ML Overview

Here's an analysis of the provided text regarding the AIGIS-SOFT device, focusing on acceptance criteria and the supporting study:

Key Takeaway: This 510(k) summary is for a dental casting alloy, not a software or AI-driven medical device. Therefore, the questions regarding AI performance, reader studies, ground truth establishment for algorithms, and training set sizes are not applicable to this submission. The "study" described is a comparison of material properties to a predicate device.

Acceptance Criteria and Device Performance

The acceptance criteria for AIGIS-SOFT are not explicitly stated as numerical targets in the same way one might find for a diagnostic device. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a legally marketed predicate device (ARGENCO 83) based on composition and physical/mechanical properties. The performance is assessed by comparing these properties.

Table of Acceptance Criteria and Reported Device Performance

Criterion (Implicit Acceptance)	Predicate Device (ARGENCO 83) Performance	AIGIS-SOFT Performance	Meets Acceptance Criteria?
Composition	Main elements & concentrations not explicitly detailed, but implied to be "very similar" to AIGIS-SOFT	Main elements & concentrations similar to ARGENCO 83 (implied high gold content)	Yes (based on "almost identical" main elements and concentration)
Melting Point Range	1,730-1,760 °F	1,922-2,002 °F	Yes (difference not deemed to affect safety/effectiveness)
Hardness (Vickers)	80	60	Yes (difference not deemed to affect safety/effectiveness)
Yield Strength (MPa)	103	85	Yes (difference not deemed to affect safety/effectiveness)
Elongation (%)	35	45	Yes (difference not deemed to affect safety/effectiveness)
Density (g/cm³)	16.6	17.2	Yes (difference not deemed to affect safety/effectiveness)
Biological Compatibility	Assumed safe	Assumed safe (due to similar composition)	Yes (based on assumption of similar biocompatibility)
Intended Use	Inlay, onlay, crown and bridge alloy	Inlay, onlay, crown and bridge, short/long span bridges, removable partials	Yes (similar intended uses)

Summary of the Study:

The study proving the device meets the acceptance criteria is a comparison study against a predicate device, ARGENCO 83 (K893384). The core of the study involved:

Chemical Composition Analysis: Comparing the elemental composition (though specific percentages are not fully tabulated for both in the provided text). The submission states, "The main elements and their concentration are almost identical."
Physical and Mechanical Properties Testing: Measuring key properties such as melting point, hardness, yield strength, elongation, and density for both AIGIS-SOFT and the predicate device. These are presented in a direct comparison table.

The conclusion drawn from this comparative study is that "AIGIS-SOFT is substantially equivalent to ARGENCO 83 and the minor differences between them do not affect safety or effectiveness."

Specific Information Requested:

Given the nature of the device (a dental alloy), most of the requested points related to AI/software performance are not applicable.

Table of Acceptance Criteria and Reported Device Performance: (See table above). The acceptance criterion is "substantial equivalence" to the predicate, with reported performance being the direct comparison of material properties.
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in terms of number of units of alloy tested, but implies standard material testing methods (e.g., tensile tests, hardness measurements) would involve multiple samples. No "test set" in the context of an algorithm.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It's standard materials testing data, likely generated in a lab setting.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- N/A. This is a material properties comparison; there's no "ground truth" established by human experts in the context of diagnostic interpretation. Physical measurements (e.g., melting point, hardness) are empirically determined.
Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:
- N/A. No expert adjudication is applicable for material property measurements.
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. AIGIS-SOFT is a physical dental alloy, not an AI or imaging device, so no MRMC study was performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Empirical Measurement Data: The "ground truth" for the properties comes from direct physical and chemical measurements (e.g., melting point via calorimetry, hardness via Vickers indenter, elemental composition via spectroscopic methods). The "truth" for biocompatibility is inferred from chemical similarity.
The sample size for the training set:
- N/A. There is no "training set" as this is not a machine learning algorithm.
How the ground truth for the training set was established:
- N/A. Not applicable, as there is no training set for an algorithm.

Summary

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K024136

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

Date of Summary: Dec 15, 2002

Trade name:	AIGIS-SOFT
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 83 510(k) number: K893384

SLMMARY OF THE TECHNOLOGICAL CHARACTERISTICS

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

Comparison of composition:

COMPOSITION (WEIGH10
evice Name		F
1
A MIN CHANNEW AND THE LE AND START CONNECT CONNUMER CONNUMof an and any anywayTI	31	CONSULTION COLLECTION CONSULTER CONSULTER COUNCE CONSULTION CONSULTION AND CONSULTION CONSULTION AND CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULT

COMPOSITION (WEIGHT %)

Comparison of physical and mechanical properties:

Alloy	Melting Point Range (°F)	Hardness (Vickers)	Yield Strength (MPa)	Elongation (%)	Density (g/cm3)
ARGENCO 83	1,730-1,760	80	103	35	16.6
AIGIS-SOFT	1,922-2,002	60	85	45	17.2

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Ciscussion:

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. AIGIS-SOFT is an inlay, onlay, crown and bridge alloy. This device is dependable 83% gold alloy with a high gold appearance. AIGIS-SOFT is excellent for inlays, three-quarter crowns, long and short-span bridges. AIGIS-SOFT is substantially equivalent to ARGENCO 83 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 black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized caduceus with three lines representing the human form. The symbol is placed to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT FOR HEALTH & HUMAN SERVICES - USA".

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: K024136 Trade/Device Name: AIGIS-SOFT 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 vours.

Susan Quares

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. Ste. 205, Anaheim, CA 92804

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

INDICATIONS FOR USE

510(K) Number : K024136

Device Name(s) : AIGIS-SOFT

AIGIS-SOFT 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(OE.D)

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MR a/h for MSR

nesthesiology, 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.