(84 days)
AIGIS-SUPER is intended for manufacturing
- Inlay / Onlays -
- Crowns -
- Short span bridges -
- Long span bridges -
- Removable partials -
AIGIS-SUPER is an inlay, onlay, crown and bridge alloy. This device is dependable 53% gold alloy with a high gold appearance. AIGIS-SUPER is excellent for inlays, three-quarter crowns, long and short-span bridges.
The provided document is a 510(k) summary for a dental casting alloy named AIGIS-SUPER. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, JENSEN'S JYE. The focus of the evaluation is on the material properties, not an AI/ML device.
Therefore, many of the questions regarding acceptance criteria for an AI/ML device, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this document.
However, I can extract the acceptance criteria and performance data related to the physical and mechanical properties of the dental alloy.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for AIGIS-SUPER are implicitly defined by its substantial equivalence to the predicate device, JENSEN'S JYE. While explicit numerical ranges for acceptance aren't provided, the comparison of properties indicates that AIGIS-SUPER should have similar or acceptable ranges for these properties.
| Property | Predicate Device (JYE) | Test Device (AIGIS-SUPER) | Acceptance Criteria (Implicit from Predicate) | Meets Criteria? |
|---|---|---|---|---|
| Melting Point Range (°F) | 1,545 - 1,635 | 1,768 - 1,948 | Similar range to JYE | Yes (discussed) |
| Hardness (Vickers) | 170 | 150 | Similar to JYE (within reasonable tolerance) | Yes (discussed) |
| Yield Strength (MPa) | 345 | 300 | Similar to JYE (within reasonable tolerance) | Yes (discussed) |
| Elongation (%) | 23 | 21 | Similar to JYE (within reasonable tolerance) | Yes (discussed) |
| Density (g/cm³) | 12.8 | 13.8 | Similar to JYE (within reasonable tolerance) | Yes (discussed) |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a comparison of technological characteristics, specifically focusing on the composition and physical/mechanical properties. The test methods applied are stated as per ANSI/ADA 5 and ISO 9693.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test (e.g., how many samples were tested for hardness, melting point). The document presents summary values.
- Data Provenance: Not specified. It's a manufacturing specification/test rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not a diagnostic device involving expert interpretation of medical images or data. The "ground truth" here is the measured physical and mechanical properties of the material, assessed against established standards (ANSI/ADA 5 and ISO 9693) and comparison to the predicate device.
4. Adjudication method for the test set:
- Not applicable. This is not a study requiring adjudication of expert opinions.
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 not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
- The "ground truth" in this context is the measured physical and mechanical properties of the dental alloy, determined through standardized test methods (ANSI/ADA 5 and ISO 9693). This is compared against the known properties of the legally marketed predicate device (JENSEN'S JYE).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set in the AI sense.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an AI/ML model.
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Ko24142
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 |
Dec 15, 2002 Date of Summary:
| Trade name: | AIGIS-SUPER |
|---|---|
| Common: | Dental casting alloy |
| Classification name: | Gold based alloys and precious metal alloys forclinical use |
| Product code: | EJT |
| Classification: | Class II |
Legally marketed device: JENSEN'S JYE 510(k) number:
SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS
Test methods applied: as in ANSI/ADA 5 and ISO 9693
Comparison of composition:
| And Am S & S & S & S & S . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . C . | CMAN BAFF PARTER STATES STATE Wand and the commission and the program | 11 11 1 1 1 1 1 1 1 2 2 2 2 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | |||||
|---|---|---|---|---|---|---|---|
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COMPOSITION WEICHT W
Comparison of physical and mechanical properties:
| Alloy | Melting Point Range (°F) | Hardness (Vickers) | Yield Strength (MPa) | Elongation (%) | Density (g/cm3) |
|---|---|---|---|---|---|
| JYE | 1,545 - 1,635 | 170 | 345 | 23 | 12.8 |
| AIGIS-SUPER | 1,768-1,948 | 150 | 300 | 21 | 13.8 |
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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-SUIPER is an inlay, onlay, crown and bridge alloy. This device is dependable 53% gold alloy with a high gold appearance. AIGIS-SUPER is excellent for inlays, three-quarter crowns, long and short-span bridges. AIGIS-SUPER is substantially equivalent to JENSEN'S JYE and the minor differences between them do not affect safety or effectiveness.
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 2003
Mr. Dae-Kyu Chang SB LUCIUS, Incorporated 9778 Katella Avenue, Suite 205 Anaheim, California 92804
Re: K024142
Trade/Device Name: AIGIS-SUPER 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 (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 Tanner
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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SE LUCIUS, INC 9778 Katella Ave. Ste. 205, Anaheim, CA 92804
Phone: (714) 530-2814, Fax : (714) 530-3448,
INDICATIONS FOR USE
510(K) Number : K₀24/4₂
Device Name(s) : AIGIS-SUPER
AIGIS-SUPER 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)
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siology, General Hospital. 510(k) Number
10
§ 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.