AIGIS-PT is an inlay, onlay, crown and bridge alloy. This device is dependable 77% gold alloy with a high gold appearance. AIGIS-PT is excellent for inlays, three-quarter crowns, long and short-span bridges.

AI/ML Overview

Here's a summary of the acceptance criteria and the study for the AIGIS-PT device, based on the provided text.

Based on the provided 510(k) summary, AIGIS-PT is a dental casting alloy, and its acceptance criteria and study are based on demonstrating substantial equivalence to a legally marketed predicate device (AUROFLUID 2PF) through comparisons of chemical composition and physical/mechanical properties, according to established standards. This is not a study of an AI-based medical device, but rather a traditional materials science regulatory submission. Therefore, many of the requested fields related to AI device performance (like sample sizes for test sets, expert ground truth, MRMC studies, standalone performance) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the comparison to the predicate device and the adherence to industry standards. The reported device performance is presented in comparison to the predicate.

Property	Predicate (AUROFLUID 2PF) Performance / Acceptance Criteria	AIGIS-PT Reported Performance	Meets Criteria?
Composition	Not explicitly numerical criteria, but "main elements and their concentration are almost identical" to predicate.	"main elements and their concentration are almost identical" to predicate (77% gold alloy).	Yes (by qualitative comparison)
Melting Point Range	1,705-1,768 °F	1,807-1,868 °F	Yes (comparable range, within acceptable variation for alloys)
Hardness (Vickers)	125	143	Yes (comparable)
Yield Strength (MPa)	260	220	Yes (comparable)
Elongation (%)	40	33	Yes (comparable)
Density (g/cm³)	16.0	16.3	Yes (comparable)
Biocompatibility	Assumed similar to predicate due to similar composition	Assumed similar to predicate due to similar composition	Yes (by assumption)

Conclusion from data: The submission concludes that "AIGIS-PT is substantially equivalent to AUROFLUID 2PF and the minor differences between them do not affect safety or effectiveness."

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

Sample Size for Test Set: Not applicable. This is a material characterization rather than a clinical study involving a "test set" in the context of AI. The properties are inherent to the material formulation.
Data Provenance: Not specified, but likely from laboratory testing conducted by the manufacturer, SB Lucius, Inc.

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

Number of Experts: Not applicable. Ground truth for material properties is established through standardized laboratory testing, not expert consensus.
Qualifications of Experts: N/A

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Material properties are measured objectively.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No. This is not a study assessing reader performance with or without AI.

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

Standalone Study: No. This is not an AI device.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for the device's properties is established through standardized laboratory testing as per ANSI/ADA 5 and ISO 9693 standards. These standards define the methods for measuring properties like melting point, hardness, yield strength, elongation, and density.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not an AI device that requires a "training set."

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

How Ground Truth was Established: Not applicable.

Summary

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K0241444

510(K) SUMMARY

MAR 0 7 2003

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

Dec 15, 2002 Date of Summary:

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

Legally marketed device: AUROFLUID 2PF 510(k) number: K944572

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS

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

Comparison of composition:

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Comparison of physical and mechanical properties:

Alloy	Melting Point Range (°F)	Hardness (Vickers)	Yield Strength (MPa)	Elongation (%)	Density (g/cm3)
AUROFLUID 2PF	1,705-1,768	125	260	40	16.0
AIGIS-PT	1,807-1,868	143	220	33	16.3

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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-PT is an inlay, onlay, crown and bridge alloy. This device is dependable 77% gold alloy with a high gold appearance. AIGIS-PT is excellent for inlays, three-quarter crowns, long and short-span bridges. AIGIS-PT is substantially equivalent to AUROFLUID 2PF and the minor differences 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 a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

MAR 0 7 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: K024144

Trade/Device Name: AIGIS-PT 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 Runner

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-PT

AIGIS-PT 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)

Robert Betz DDS for D.K. Mulby
(Division Sign Off)

Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number. K024144

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.