(182 days)
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
High gold casting alloy
The provided document is a 510(k) summary for a dental casting alloy, AURELUX 77. This document focuses on demonstrating substantial equivalence to a predicate device (Jelenko Jel 96) rather than proving device performance against specific acceptance criteria in a clinical or standalone study as one would expect for an AI/CADe device.
Therefore, the information required to answer the prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not present in this document because it describes the submission of a material device, not a software or AI-driven device.
However, I can extract the comparison data between the new device and the predicate device, which serves as the "performance" demonstrated for this type of submission.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this type of device are intrinsic to demonstrating "substantial equivalence" to a legally marketed predicate device. This means the new device's characteristics should be similar enough to the predicate device that it doesn't raise new questions of safety or effectiveness. The comparison table below effectively acts as the "performance" data against these implicit acceptance criteria of substantial equivalence.
| Characteristic | Acceptance Criteria (Predicate: Jel 96) | Reported Device Performance (Aurelux 77) |
|---|---|---|
| Composition (weight%) | ||
| Au | 78 | 76.6 |
| Ag | 1.2 | 1.2 |
| Pt | 6 | 9.9 |
| Pd | 12 | 9.3 |
| Cu | 4.5 | 0.5 |
| Fe | 1 | 0.2 |
| Sn | x (<1%) | 0.6 |
| In | x (<1%) | 1.5 |
| Ir | x (<1%) | 0 |
| Noble metal content | > 95% (implied by individual components) | > 95% (as stated in discussion) |
| Base metal concentration | Implied by individual components | < 1% difference (as stated in discussion) |
| Physical/Mechanical | ||
| Melting point range (solid.) | 1170 °C | 1150 °C |
| Melting point range (liquid) | 1260 °C | 1230 °C |
| Hardness (Vickers 5/30), soft | N/A | 200 |
| Hardness (Vickers 5/30), hard | 255 | 245 |
| Yield strength (MPa), soft | N/A | 350 |
| Yield strength (MPa), hard | 655 | 650 |
| Elongation (%), soft | N/A | 19 |
| Elongation (%), hard | 4 | 11 |
| CTE (x10-6/°C) | 14.5 | 14.1 |
| Density (g/cm3) | 17.2 | 18.5 |
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 applicable and not provided in the document. The "study" here is a comparison of material properties, not a clinical trial with a test set of patients or images. The "data" are the results of material tests (chemical composition analysis, melting point tests, hardness tests, etc.), which are inherent properties of the alloy. The provenance would be the laboratory where these tests were conducted, which is not specified but would typically be an internal or contracted materials testing lab.
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. "Ground truth" in the context of an AI/CADe device refers to highly accurate clinical diagnoses or annotations. For a material science submission, "ground truth" is established through standardized laboratory testing yielding objective physical and chemical measurements. There are no human experts establishing ground truth in the clinical sense for this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are relevant for human interpretation tasks, especially in AI/CADe studies where there might be disagreement among experts. Here, the "test set" consists of laboratory measurements, not human interpretations.
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. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. This document describes a dental casting alloy, not an AI or diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. Standalone performance refers to the performance of an AI algorithm independent of human intervention. This document describes a physical material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this material device, the "ground truth" (or the reference standard for comparison) is derived from standardized physical and chemical laboratory testing and measurements performed on both the predicate device (Jel 96) and the new device (Aurelux 77) according to recognized test methods (ANSI/ADA 5 and ISO 9693). There is no "pathology" or "outcomes data" in the clinical sense for this type of submission.
8. The sample size for the training set
This is not applicable. "Training set" refers to data used to train an AI algorithm. This document describes a physical material.
9. How the ground truth for the training set was established
This is not applicable. There is no training set or AI algorithm in this submission.
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Image /page/0/Picture/1 description: The image shows a logo with the word "AUREX" in bold, capitalized letters. Above the word is a black geometric shape that resembles two overlapping triangles or mountains. A horizontal line underlines the word "AUREX", emphasizing the brand name.
P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918
510 (k) Summary
AURELUX 77 Trade name: Common name: Dental casting alloy Gold based alloys and precious metal alloys for clinical use Classification name: Class ification number: EJT
Legally marketed device: Jelenko Jel 96 Description of the device: High gold casting alloy Intended use of the device: Type IV restorations 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 | Ag | Pt | Pd | Cu | Fe | Sn | In | Ir | |
| Legal | Jel 96 | 78 | 1.2 | 6 | 12 | 4.5 | 1 | x | x | x |
| New | Aurelux 77 | 76.6 | 1.2 | 9.9 | 9.3 | 0.5 | 0.2 | 0.6 | .1.5 | 0. |
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 Jel 96 | 1170 | 1260 | 255 | 655 | 4 | 14.5 | 17.2 | |||
| New Aurelux 77 | 1150 | 1230 | 200 | 245 | 350 | 650 | 19 | 11 | 14.1 | 18.5 |
Discussion
With the exception of a very small copper content the two alloys have almost identical composition and properties. The noble metal content in both alloys is higher than 95 %. Less than 1 % difference in base metal concentration.
Conclusion
The major constituent (Au) and the noble metal content are similar. Even the residuals are the same elements.
The very high noble metal content suggest an effective biocompatibility
Image /page/0/Picture/22 description: The image shows a logo with the text "TUV CERT" stacked on top of each other. The logo is enclosed in a rectangular box with rounded corners. There are two curved lines above the text, and the text "ISO 9001" is below the text.
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:
DEC 1 9 1997
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jerome D. Davis Managing Director Aurex Precious Metal Industries (Pty) Ltd. P.O. Box 509 Edenvale 1610 Republic of South Africa
K972946 Re : Trade Name: Aurelux 77 Requlatory Class: II Product Code: EJT October 6, 1997 Dated: Received: October 17, 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 reqistration, 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 requlations 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 Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you miqht have under sections 531
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Page 2 - Mr. Davis
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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,
Timothy A. Ulatowski
Timothy A. Ulatowski 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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Image /page/3/Picture/1 description: The image shows a logo with the word "AUREX" in bold, capitalized letters. Above the word is a black geometric shape that resembles two overlapping triangles or mountains. A horizontal line underlines the word "AUREX", emphasizing the brand name.
P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918
510 (k) Summary
AURELUX 77 Trade name: Common name: Dental casting alloy Gold based alloys and precious metal alloys for clinical use Classification name: Class ification number: EJT
Legally marketed device: Jelenko Jel 96 Description of the device: High gold casting alloy Intended use of the device: Type IV restorations 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 | Ag | Pt | Pd | Cu | Fe | Sn | In | Ir | |
| Legal | Jel 96 | 78 | 1.2 | 6 | 12 | 4.5 | 1 | x | x | x |
| New | Aurelux 77 | 76.6 | 1.2 | 9.9 | 9.3 | 0.5 | 0.2 | 0.6 | .1.5 | 0. |
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 Jel 96 | 1170 | 1260 | 255 | 655 | 4 | 14.5 | 17.2 | |||
| New Aurelux 77 | 1150 | 1230 | 200 | 245 | 350 | 650 | 19 | 11 | 14.1 | 18.5 |
Discussion
With the exception of a very small copper content the two alloys have almost identical composition and properties. The noble metal content in both alloys is higher than 95 %. Less than 1 % difference in base metal concentration.
Conclusion
The major constituent (Au) and the noble metal content are similar. Even the residuals are the same elements.
The very high noble metal content suggest an effective biocompatibility
Image /page/3/Picture/22 description: The image shows a logo with the text "TUV CERT" stacked on top of each other. The logo is enclosed in a rectangular box with rounded corners. There are two curved lines above the text, and the text "ISO 9001" is below the text.
-11-
{4}------------------------------------------------
:
DEC 1 9 1997
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jerome D. Davis Managing Director Aurex Precious Metal Industries (Pty) Ltd. P.O. Box 509 Edenvale 1610 Republic of South Africa
K972946 Re : Trade Name: Aurelux 77 Requlatory Class: II Product Code: EJT October 6, 1997 Dated: Received: October 17, 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 reqistration, 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 requlations 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 Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you miqht have under sections 531
{5}------------------------------------------------
Page 2 - Mr. Davis
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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,
Timothy A. Ulatowski
Timothy A. Ulatowski 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: _________________________________________________________________________________________________________________________________________________________________ 77
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)
Susan Runoe
(Division Sign-Off) Division of Den and General H 510(k) Numb
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.