AIGIS-FINE is an inlay, onlay, crown and bridge alloy. This device is dependable 7 1% gold alloy with a high gold appearance. AIGIS-FINE 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-FINE, and its substantial equivalence to a predicate device, AUROFLUID M. The substantial equivalence is based on a comparison of composition and physical/mechanical properties.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly defined by the properties of the predicate device, AUROFLUID M. The newer device, AIGIS-FINE, is considered acceptable if its properties are substantially equivalent and do not negatively impact safety or effectiveness.

Property	Acceptance Criteria (AUROFLUID M)	Reported Device Performance (AIGIS-FINE)
Composition (Weight %)	Very similar to AUROFLUID M	"Main elements and their concentration are almost identical"
Gold (Au)	Not explicitly stated, implied to be high	71% gold alloy (implied to be similar to AUROFLUID M)
Melting Point Range (°F)	1,687-1,777	1,730-1,832
Hardness (Vickers)	155	145
Yield Strength (MPa)	340	250
Elongation (%)	27	26
Density (g/cm3)	15.4	15.19

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

Sample Size: Not explicitly stated. The comparison is made based on material properties, which are typically derived from standardized testing of material samples. The text does not provide details on the number of samples tested for each property.
Data Provenance: Not explicitly stated. The data is presented as a comparison between the applicant's device (AIGIS-FINE) and a legally marketed predicate (AUROFLUID M). It's reasonable to assume the AIGIS-FINE data was generated by the applicant (SB LUCIUS, INC.), likely from laboratory testing. The provenance of the AUROFLUID M data is not mentioned but would have been established during its own regulatory approval. The study is retrospective in the sense that it relies on existing data for the predicate device and newly generated data for the proposed device for comparison.

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

This type of study does not involve experts establishing ground truth for a test set in the way a diagnostic imaging AI algorithm would. Instead, the "ground truth" for material properties is established through standardized laboratory testing (as in ANSI/ADA 5 and ISO 9693). The results of these tests (melting point, hardness, yield strength, etc.) are objective measurements, not subjective expert opinions.

4. Adjudication method for the test set

Not applicable. There is no adjudication method described as this is a comparison of material properties, not a review of expert interpretations.

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 comparison of material properties for a dental casting alloy, not a diagnostic imaging device involving human readers or AI.

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

Not applicable. This is a material science comparison, not an algorithmic performance study.

7. The type of ground truth used

The ground truth used is based on standardized physical and mechanical property measurements of the dental alloy. These are objective laboratory measurements, not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This is not a machine learning study, so there is no concept of a training set.

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

Not applicable. As there is no training set, there is no ground truth established for it.

Summary

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K024143

MAR 1 0 2003

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: Dec 15, 2002

Trade name: Common: Classification name: AIGIS-FINE Dental casting alloy Gold based alloys and precious metal alloys for clinical use EJT Class II

Froduct code: Classification:

Legally marketed device: AUROFLUID M 510(k) number: K993475

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS

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

Comparison of composition:

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POSITION (WEIGHT %)

Comparison of physical and mechanical properties:

Alloy	Melting Point Range (°F)	Hardness (Vickers)	Yield Strength (MPa)	Elongation (%)	Density (g/cm3)
AUROFLUID M	1,687-1,777	155	340	27	15.4
AIGIS-FINE	1,730-1,832	145	250	26	15.19

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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.

Conclusion:

The main elements and their concentration are almost identical. AIGIS-FINE is an inlay, onlay, crown and bridge alloy. This device is dependable 7 1% gold alloy with a high gold appearance. AIGIS-FINE is excellent for inlays, three-quarter crowns, long and short-span bridges. AIGIS-FINE is substantially equivalent to Metalor's AUROFLUID M and the minor d fferences between them do not affect safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines connecting them. The logo is black and white.

MAR 1 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K024143

Trade/Device Name: AIGIS-Fine 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 vour 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 (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). 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 Purser

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 : ______________________________________________________________________________________________________________________________________________________________

Device Name(s) : AIGIS-FINE

AIGIS-FINE 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)

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concurrence of chrd,office of device evaluation(oed)

Mccarthy for MSR

esiology. 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.