(82 days)
LUCIUS 62 is intended for manufacturing:
- Inlay / Onlays -
- Crowns -
- Short span bridges -
- Long span bridges -
- Removable partials -
LUCIUS 62 is a platinum-free crown and bridge alloy. This device is dependable 62% gold alloy with a high gold appearance. LUCIUS 62 is excellent for inlays, three-quarter crowns, long and short-span bridges.
The provided text describes the 510(k) summary for a dental casting alloy, LUCIUS 62. This summary is not about a device that uses AI or involves image analysis, but rather a metal alloy for dental restorations. Therefore, many of the requested points regarding AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details, and ground truth establishment methods typical for AI/ML) are not applicable to this document.
The document focuses on establishing substantial equivalence to a predicate device (Jel-62) based on chemical composition and physical/mechanical properties, as per traditional medical device regulations for materials.
Here's an attempt to answer the applicable questions based on the provided text:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implied by the comparison to the predicate device, Jel-62, and adherence to "Test methods applied: as in ANSI/ADA 5 and ISO 9693." The device performance is considered acceptable if it is "substantially equivalent" to Jel-62. No explicit target ranges or pass/fail thresholds are given, but rather a direct comparison to the predicate.
| Property | Acceptance Criteria (Predicate: Jel-62) | Reported Device Performance (LUCIUS 62) |
|---|---|---|
| Composition | Very similar to Jel-62 (implied) | Main elements and concentration almost identical |
| Melting Point Range | 1,598-1,724 °F | 1,652-1,710 °F |
| Hardness (Vickers) | 170 | 150 |
| Yield Strength (psi) | 42,000 | 40,600 |
| Elongation (%) | 45.0 | 33.1 |
| Density (g/cm³) | 14.3 | 14.1 |
Discussion on Acceptance: The document states, "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." And concludes: "LUCIUS 62 is substantially equivalent to JELENKO'S Jel-62, and the minor differences between them do not affect safety or effectiveness."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the summary. The document does not specify sample sizes for mechanical testing or details on data provenance (e.g., country of origin, retrospective/prospective nature). It simply presents comparison data.
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)
This is not applicable. The "ground truth" here is the established properties of the predicate device and the new device as measured by standard material testing methods (ANSI/ADA 5 and ISO 9693), not expert interpretation of complex data (like medical images).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically relevant for ambiguous cases in diagnostic studies resolved by expert consensus, which is not the nature of this submission.
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
This is not applicable. This device is a dental casting alloy, not an AI-powered diagnostic tool, so no MRMC study or AI assistance evaluation would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithm or an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the comparison is the physical and mechanical properties of the materials, measured according to recognized industry standards (ANSI/ADA 5 and ISO 9693). It is objective measurement data, not expert consensus, pathology, or outcomes data in the usual sense.
8. The sample size for the training set
This is not applicable. This is not an AI/ML device, so there is no training set in that context.
9. How the ground truth for the training set was established
This is not applicable. As there is no training set mentioned or implied for an AI/ML context, the method for establishing its "ground truth" is irrelevant.
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SEP = 3 2002
510(K) SUMMARY OF STATEMENT
Lucius Metals Com. Submitter of 510(k): 4241 Farquhar Ave. #2, Los Alamitos, CA 90720 Phone/Fax: (562) 799-6626, Cell: (562) 477-0155
| Contact person: | Dae Kyu Chang |
|---|---|
| Phone: | (562) 799-6626 |
| Fax: | (562) 799-6626 |
| E-mail: | Gatorkr@yahoo.co.kr |
Date of Summary: June 5, 2002
| Trade name: | LUCIUS 62 |
|---|---|
| Common: | Dental casting alloy |
| Classification name: | Gold based alloys and precious metal alloys forclinical use |
| Product code: | EJT |
| Classification: | Class II |
Legally marketed device: Jel-62 510(k) number: K874308
Test methods applied: as in ANSI/ADA 5 and ISO 9693
Comparison of composition:
| 101 ·iul | Pt(% | 1 / 0 / 0 / 1 / 0 / 1 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 0 / 010 | ~101 | 101oul | |
|---|---|---|---|---|---|
| -60lel-UL | 00 00 | 0.00 | 3.00 | 0620. | 3.0 |
| ે જિ_ucius & | ۵۹ ۱۳۹ | 0.00 | 500 | 26.00 |
Comparison of physical and mechanical properties:
| Alloy | Melting PointRange(°F) | Hardness(Vickers) | Yield Strength(psi) | Elongation(%) | Density(g/cm3) |
|---|---|---|---|---|---|
| Jel-62 | 1,598-1,724 | 170 | 42,000 | 45.0 | 14.3 |
| Lucius 62 | 1,652-1,710 | 150 | 40,600 | 33.1 | 14.1 |
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.
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Conclusion:
The main elements and their concentration are almost identical. LUCIUS 62 is a platinum-free crown and bridge alloy. This device is dependable 62% gold alloy with a high gold appearance. LUCIUS 62 is excellent for inlays, three-quarter crowns, long and short-span bridges. LUCIUS 62 is substantially equivalent to JELENKO'S Jel-62, and the minor differences between them do not affect safety or effectiveness.
Statement of indication for use:
LUCIUS 62 is intended for manufacturing
- Inlay / Onlays ・
- Crowns -
- Short span bridges -
- -Long span bridges
- Removable partials -
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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 a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the top half of the circle. The text is in all capital letters and is evenly spaced around the curve of the circle.
Food and Drug Administration -9200 Corporate Boulevard Rockville MD 20850
SEP - 3 2002
Mr. Dae Kyu Chang President Lucius Metals Company 4241 Farquhar Avenue, # 2 Los Alamitos, California 90720
Re: K021948
Trade/Device Name: LUCIUS 62 Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: June 5, 2002 Received: June 13, 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.
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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Kuz1948
STATEMENT OF INDICATION FOR USE
LUCIUS 62 is intended for manufacturing:
- Inlay / Onlays -
- Crowns -
- Short span bridges -
- Long span bridges -
- Removable partials -
Susa Runges
(Division Sign-Off) Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K021941
§ 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.