(77 days)
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
Medium gold casting alloy
This document is a 510(k) premarket notification for a dental casting alloy, AUREBOND 51. The information provided is primarily focused on demonstrating substantial equivalence to a predicate device, Jelenko Olympia, rather than presenting a study proving the device meets specific performance acceptance criteria for an AI/ML medical device.
Therefore, most of the requested information regarding acceptance criteria, study design for AI/ML performance, sample sizes, expert involvement, and ground truth establishment is not present in this document. This typically applies to AI/ML software as a medical device (SaMD) or as part of a medical device (SiMD).
Here's an attempt to answer the questions based only on the provided text, recognizing its limitations for the requested context:
1. A table of acceptance criteria and the reported device performance
Based on the document, the "acceptance criteria" are implied to be the ranges and values of the predicate device (Jelenko Olympia) for its composition and physical/mechanical properties. The "reported device performance" are the measured values for the new device (Aurebond 51).
| Property | Predicate Device (Olympia) Criteria | New Device (Aurebond 51) Performance | Acceptance/Comparison |
|---|---|---|---|
| Composition (weight%) | |||
| Au | 51.5 | 51.4 | Similar |
| Pd | 38.4 | 38.5 | Similar |
| Ga | 1.5 | 1.1 | Similar |
| In | 8.5 | 8.7 | Similar |
| Ru | (not present) | 0.3 (less than 1%) | Minor addition |
| Physical/Mechanical | |||
| Melting Point Range - solid. (°C) | 1200 | 1260 | Different |
| Melting Point Range - liquid (°C) | 1300 | 1290 | Different |
| Hardness (Vickers 5/30) - soft | 245 | 235 | Similar |
| Hardness (Vickers 5/30) - hard | (not reported) | 275 | New value |
| Yield Strength (MPa) - soft | 552 | 530 | Similar |
| Yield Strength (MPa) - hard | (not reported) | 580 | New value |
| Elongation (%) - soft | 5 | 20 | Different (better) |
| Elongation (%) - hard | (not reported) | 15 | New value |
| CTE (x10^-6/°C) | 14.2 | 13.9 | Similar |
| Density (g/cm^3) | 13.7 | 14.0 | Similar |
Conclusion from the document: "Essentially similar composition, only slight difference in mechanical properties." This indicates that the observed differences were deemed acceptable for substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. Standard material testing would use multiple samples, but the exact number isn't in the provided text.
- Data Provenance: The device manufacturer (Aurex) is in the Republic of South Africa. The testing methods applied are "as in ANSI/ADA 5 and ISO 9693," which are international standards for dental materials. The raw data origin (country, retrospective/prospective) is not specified.
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 to a material testing submission. "Ground truth" in this context would be physical and chemical measurements performed according to established standards, not expert consensus or interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Material testing follows standardized methods, not expert adjudication.
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 a material science submission, not an AI/ML diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a material science submission, not an AI/ML diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by standardized physical and chemical testing methods using laboratory equipment, as referenced by ANSI/ADA 5 and ISO 9693 standards. It's not based on expert consensus, pathology, or outcomes data in the way an AI/ML diagnostic would be.
8. The sample size for the training set
Not applicable. This is a material science submission, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is a material science submission, not an AI/ML device.
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Image /page/0/Picture/0 description: The image shows a logo for AUREX. The logo consists of a geometric shape above the word "AUREX". The geometric shape is made up of three overlapping triangles, creating an abstract design. The word "AUREX" is written in a bold, sans-serif font.
P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918
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510 (k) Summary
AUREBOND 51 Trade name: Dental casting alloy Common name: Gold based alloys and precious metal alloys for clinical use Classification name: Class ification number: EJT
Legally marketed device: Jelenko Olympia Description of the device: Medium gold casting alloy Intended use of the device: Type IV restoration with porcelain veneering
Summary of the technological characteristics
Test methods applied: as in ANSI/ADA 5 and ISO 9693
Comparison of composition:
| ALLOY | COMPOSITION (weight%) | |||||
|---|---|---|---|---|---|---|
| Name | Au | Pd | Ga | In | Ru | |
| Legal | Olympia | 51.5 | 38.4 | 1.5 | 8.5 | |
| New | Aurebond 51 | 51.4 | 38.5 | 1.1 | 8.7 | 0.3 |
x is less than 1 %
Comparison of physical and mechanical properties
| ALLOY | Melting point range (°C) | Hardness (Vickers 5/30) | Yield strength (MPa) | Elongation (%) | CTE (x10-6/°C) | Density (g/cm3) | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| Name | solid. | liquid | soft | hard | soft | hard | soft | hard | ||
| Legal Olympia | 1200 | 1300 | 245 | 552 | 5 | 14.2 | 13.7 | |||
| New Aurebond 51 | 1260 | 1290 | 235 | 275 | 530 | 580 | 20 | 15 | 13.9 | 14.0 |
Discussion
Discussion
Conclusion
Essentially similar composition, only slight difference in mechanical properties.
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SEP - 5 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jerome D. Davis Manaqinq Director Aurex Precious Metal Industries (PTY) LTD. P.O. Box 509 -------Edenvale 1610 Republic of South Africa
K972952 Re : Trade Name: Aurebond 51 Regulatory Class: II EJT Product Code: Dated: June 13, 1997 Received: June 20, 1997
Dear Mr. Davis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). "You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
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Page 2 - Mr. Davis ----
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Kj Matron
Timothy A. Ulatow Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: AUREBOND 51
Indications For Use:
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Super AM (Division Sign-Off) Distribution Sign-On)
Dision of Dantal, Infection Control, and General Hospital E : Olk) Number
Prescription Use er 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.