AIGIS-XO is an inlay, onlay, crown and bridge alloy. This device is dependable 82% gold alloy with a high gold appearance. AIGIS-XO is excellent for inlays, three-quarter crowns, long and short-span bridges.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of a medical AI device.

Instead, the document is a 510(k) summary for a dental casting alloy named "AIGIS-XO," seeking market clearance as a Class II medical device. The 510(k) process is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving performance against specific acceptance criteria for AI algorithms.

Here's why the requested information cannot be extracted from this document:

Device Type: The device is "AIGIS-XO, Dental casting alloy" (a physical material), not an AI-powered diagnostic or assistive tool.
Study Type: The document describes a comparison of the new device (AIGIS-XO) to a predicate device (BIOCLUS 4) based on composition and physical/mechanical properties (e.g., melting point, hardness, yield strength, elongation, density), not performance metrics like sensitivity, specificity, or reader agreement that would be relevant for an AI study.
No AI Component: There is no mention of any AI algorithm, machine learning, deep learning, or digital imaging analysis.
No Human Reader Studies: Since it's a dental alloy, there are no human reader studies (MRMC or standalone) involved.
No Training/Test Sets: The concepts of training sets, test sets, ground truth established by experts, or adjudication methods are not applicable to the documentation of a dental alloy's properties.

Therefore, I cannot provide the requested table and study details as they pertain to AI device evaluation. The document focuses on demonstrating chemical and physical property similarities to an existing device to establish substantial equivalence.

Summary

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024145

MAR 0 7 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-XODental casting alloyGold based alloys and precious metal alloys forclinical use
Product code:	EJT
Classification:	Class II

Legally marketed device: BIOCCLUS 4 510(k) number: K960104

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS

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

Comparison of composition:

COMPOSITION (WEIGHT %)
Device Name	Au	Pt	Pd	Ag	CU	Zn	IR/In
BIOCCLUS 4	85.8	11.0	-	-	-	0.05	<1.0
AIGIS-XO	56.0	0.05	2.5	30.0	9.92	1.0	0.08

COMPOSITION (WEIGHT %)

Comparison of physical and mechanical properties:

Alloy	Melting PointRange (°F)	Hardness(Vickers)	YieldStrength(MPa)	Elongation(%)	Density(g/cm3)
BIOCCLUS 4	1,822 - 1,966	150	360	12	19.0
AIGIS-XO	1,813-1,847	133	225	46	16.97

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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-XO is an inlay, onlay, crown and bridge alloy. This device is dependable 82% gold alloy with a high gold appearance. AIGIS-XO is excellent for inlays, three-quarter crowns, long and short-span bridges. AIGIS-XO is substantially equivalent to BIOCCLUS 4 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 7 2003

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

Re: K024145

Trade/Device Name: AIGIS-XO 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, 200

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 Runser.

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

1624145 510(K) Number : ______________________________________________________________________________________________________________________________________________________________

Device Name(s) : AIGIS-XO

AIGIS-XO 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 Dr. K. Mulay
(Division Sign Off)

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number. K024145

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.