(37 days)
This is a yellow casting alloy for inlay / onlays, crowns, short span bridges, long span bridges, removable partials.
LUCIUS 76 is a platinum-free crown and bridge alloy. This device is dependable 76% gold alloy with a high gold appearance. LUCIUS 76 is an excellent for inlays, three-quarter crowns, long and short-span bridges.
The provided document is a 510(k) summary for a dental casting alloy, not an AI/ML medical device. Therefore, many of the requested details about acceptance criteria and study design for an AI/ML device are not applicable or cannot be extracted from this particular document.
However, I can provide the information that is present in the document related to the device's characteristics and its comparison to a predicate device, which serves as its "acceptance criteria" and "study" for substantial equivalence.
1. A table of acceptance criteria and the reported device performance
For a traditional medical device like a dental alloy, "acceptance criteria" for 510(k) clearance are primarily about demonstrating substantial equivalence to a legally marketed predicate device. This is typically done by comparing characteristics like composition and physical/mechanical properties. The "reported device performance" is the measured values for the new device and the predicate.
| Characteristic | Acceptance Criteria (Predicate: Argenco 77**) | Reported Device Performance (LUCIUS 76) |
|---|---|---|
| Composition (Weight %) | ||
| Au (%) | 76.0 | 76.0 |
| Pt (%) | 1.0 | 1.0 |
| Pd (%) | - (Not present) | 2.0 |
| Ag (%) | 13.0 | 11.3 |
| Cu (%) | 8.45 | 9.99 |
| Zn (%) | <1.0% | 0.68 |
| Physical and Mechanical Properties | ||
| Melting Point Range (°F) | 1,650-1,715 | 1,746-1,814 |
| Hardness (Vickers) | 120 | 148 |
| Yield Strength (MPa) | 286 | 270 |
| Elongation (%) | 40.0 | 48.0 |
Discussion of Acceptance Criteria Approach for this Device:
The "acceptance criteria" here is that the LUCIUS 76 device must be sufficiently similar in composition and performance to the predicate device (Argenco 77**) to ensure comparable safety and effectiveness, as per the 510(k) pathway. The document explicitly states: "The main elements and their concentration are almost identical. LUCIUS 76 is a platinum-free crown and bridge alloy... LUCIUS 76 is a substantially equivalent to Argen's Argenco 77**, and the minor differences between them do not affect safety or effectiveness."
The following points are not applicable to this 510(k) submission for a dental alloy, as they relate specifically to AI/ML device evaluations. The document does not contain any information regarding these aspects.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A - This is a material science comparison, not software/AI model testing. The "test set" would refer to the samples of the alloys themselves that were tested in a laboratory. The document mentions "Test methods applied: as in ANSI/ADA 5 and ISO 9693" but does not specify sample sizes or data provenance beyond standard material testing protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- N/A - This is a material science comparison, not software/AI model testing requiring expert ground truth for classification. The "ground truth" for material properties is established by standardized laboratory testing methods, not expert consensus in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A - This is a material science comparison. Adjudication methods are relevant for subjective interpretations, not objective material property measurements.
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
- N/A - This is a dental alloy, not an AI/ML device. No human readers or AI assistance are involved in the direct "use" being evaluated here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A - This is a dental alloy, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the material properties (melting point, hardness, yield strength, elongation, composition) is based on standardized physico-chemical and mechanical testing methods (referenced as ANSI/ADA 5 and ISO 9693).
8. The sample size for the training set
- N/A - This is a dental alloy. There is no "training set" in the AI/ML sense.
9. How the ground truth for the training set was established
- N/A - This is a dental alloy. No "training set" or "ground truth for training set" in the AI/ML sense.
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1 2002 NOV
10223196
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: | Sept. 16, 2002 |
| Trade name:Common:Classification name: | LUCIUS 76Dental casting alloyGold based alloys and precious metal alloys forclinical use |
| Product code: | EJT |
| Classification: | Class II |
Legally marketed device: Argen's ARGENCO 77** 510(k) number: 893385
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(%) |
| Argenco 77** | 76.0 | 1.0 | - | 13.0 | 8.45 | <1.0% |
| LUCIUS 76 | 76.0 | 1.0 | 2.0 | 11.3 | 9.99 | 0.68 |
COMPOSITION (WEIGHT %)
Comparison of physical and mechanical properties:
| Alloy | Melting PointRange (°F) | Hardness(Vickers) | Yield Strength(MPa) | Elongation(%) |
|---|---|---|---|---|
| Argenco 77** | 1,650-1,715 | 120 | 286 | 40.0 |
| LUCIUS 76 | 1,746-1,814 | 148 | 270 | 48.0 |
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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. LUCIUS 76 is a platinum-free crown and bridge alloy. This device is dependable 76% gold alloy with a high gold appearance. LUCIUS 76 is an excellent for inlays, three-quarter crowns, long and short-span bridges. LUCIUS 76 is a substantially equivalent to Argen's Argenco 77**, and the minor differences between them do not affect safety or effectiveness.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is centered on the image. The font is a simple sans-serif font. The text is likely the header of a document or website.
Food and Drug Administrat 9200 Corporate Boulevard Rockville MD 20850
NOV 1 2002
Mr. Dae-Kyu Chang SB Lucius, Incorporated · 9778 Katella Avenue, Suite 205 Anaheim, California 92804
Re: K023196
Trade/Device Name: LUCIUS 76 Regulation Number: 21 CFR 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: September 16, 2002 Received: September 25, 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.
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.
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Page 2 - Mr. Chang
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Timothy A. Ulatowski 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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B LUCIUS,INC
Ste. 205, Anaheim, CA 92804 9778 Katella Ave.
Phone: (714) 530-2814 Fax : (/14) 530-3448
INDICATIONS FOR USE
510(K) Number : K023196
Device Name(s) : Lucius 76
This is a yellow casting alloy for 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)
Susan Pierce
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number K033196
§ 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.