(66 days)
Dental casting alloy for making dental restorations and appliances.
Low gold, silver-palladium based casting alloy
The provided document is a 510(k) summary for a dental casting alloy, Aurecast 10, seeking substantially equivalent status to a predicate device, Aurium Aurolite CB-25. The document does not describe a study or acceptance criteria in the context of device performance as typically applied to AI/ML medical devices, or medical devices requiring extensive clinical trials. Instead, it focuses on demonstrating substantial equivalence based on material composition and physical/mechanical properties.
Therefore, many of the requested elements for describing an acceptance criteria study (e.g., sample size for test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are not applicable to this type of submission.
Here's an interpretation based on the provided document, addressing the relevant points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (New Device: Aurecast 10) |
|---|---|
| Composition (weight%) | Composition (weight%) |
| Au: 10 | Au: 10 |
| Ag: 59.9 | Ag: 59.9 |
| Pd: 20 | Pd: 20 |
| Cu: 9 | Cu: 9 |
| Zn: <1 | Zn: 1.0 |
| Ru: 0 | Ru: 0.1 |
| Ir: <1 | Ir: 0 |
| Physical and Mechanical Properties | Physical and Mechanical Properties |
| Melting point range (solid.): 1000 °C | Melting point range (solid.): 1000 °C |
| Melting point range (liquid): 1030 °C | Melting point range (liquid): 1030 °C |
| Hardness (Vickers 5/30) soft: 160 | Hardness (Vickers 5/30) soft: 160 |
| Hardness (Vickers 5/30) hard: 270 | Hardness (Vickers 5/30) hard: 270 |
| Yield strength (MPa) soft: 410 | Yield strength (MPa) soft: 410 |
| Yield strength (MPa) hard: 560 | Yield strength (MPa) hard: 560 |
| Elongation (%) soft: 10 | Elongation (%) soft: 15 |
| Elongation (%) hard: 3 | Elongation (%) hard: 8 |
| Density (g/cm3): 10.6 | Density (g/cm3): 10.6 |
Discussion from the document regarding meeting criteria: "The major components of the two alloys are identical and their concentration is the same. The only difference is in the small amount of Zn and the grain refiners such as Ru and Ir. These minor differences have negligible effect upon the alloys."
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a "sample size" in terms of a population of patients or cases. Instead, the "test set" consists of comparing the properties of the new alloy (Aurecast 10) against the properties of the predicate alloy (Aurolite CB-25). It implies that samples of both alloys were characterized to obtain the reported values.
- Data Provenance: The document does not state the country of origin for the data. The manufacturer, Aurex Precious Metal Industries, is based in the Republic of South Africa. The testing methods applied are "as in ANSI/ADA 5 and ISO 8891," which are international standards for dental casting alloys. The data would be derived from laboratory characterization of the alloys, not from a retrospective or prospective patient study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. For material science comparisons, "ground truth" is typically established by standardized laboratory measurements and characterization techniques, not by expert consensus on clinical data. The standards (ANSI/ADA 5 and ISO 8891) dictate the methodology.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods like 2+1 or 3+1 are used for human review of clinical data to establish a consensus ground truth. For material properties, the "adjudication" is inherent in the standardized measurement process and the comparison of the measured values.
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 AI-powered diagnostic or assistive devices involving human interpretation of images or other clinical data. This submission pertains to a dental casting alloy, which is a material, not a device with AI interpretation.
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 software device that would have "standalone performance."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission are the measured physical and mechanical properties and chemical composition of the alloys, determined through standardized laboratory tests (ANSI/ADA 5 and ISO 8891).
8. The sample size for the training set:
- This is not applicable. There is no "training set" as this is not an AI/ML device or a device requiring a clinical study with training data.
9. How the ground truth for the training set was established:
- This is not applicable, as there is no training set.
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Image /page/0/Picture/0 description: The image shows a logo for AUREX. The logo consists of three overlapping triangles, forming a complex geometric shape. Below the triangles, the word "AUREX" is written in capital letters, with a line underneath it. The logo is black and white.
P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918
AUG 25 1997
510 (k) Summary
AURECAST 10 Trade name: Common name: Dental casting alloy Classification name: Gold based alloys and precious metal alloys for clinical use Class ification number: EJT
Legally marketed device: Aurium Aurolite CB-25 Description of the device: Low gold , silver-palladium based casting alloy Intended use of the device: Type IV restorations
Summary of the technological characteristics
Test methods applied: as in ANSI/ADA 5 and ISO 8891
Comparison of composition:
| ALLOY | COMPOSITION (weight%) | |||||||
|---|---|---|---|---|---|---|---|---|
| Name | Au | Ag | Pd | Cu | Zn | Ru | Ir | |
| Legal | AuroliteCB-25 | 10 | 59.9 | 20 | 9 | x | 0 | x |
| New | Aurecast 10 | 10 | 59.9 | 20 | 9 | 1.0 | 0.1 | 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 (%) | Density (g/cm3) | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| Name | solid. | liquid | soft | hard | soft | hard | soft | hard | ||
| Legal | AuroliteCB-25 | 1000 | 1030 | 160 | 270 | 410 | 560 | 10 | 3 | 10.6 |
| New | Aurecast 10 | 1000 | 1030 | 160 | 270 | 410 | 560 | 15 | 8 | 10.6 |
Discussion
The major components of the two alloys are identical and their concentration is the same. The only difference is in the small amount of Zn and the grain refiners such as Ru and Ir. These minor differences have negligible effect upon the alloys.
Conclusion
The two alloys are practically identical
Image /page/0/Picture/18 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. Below the text, it says "ISO 9001". There are two curved lines above the text.
Aurex Precious Metal Industries (Pty) Limited (Reg. No. 88/04891/07) Manufacturers and Refiners of Precious Metals for Dental, Jewellery and Industrial applications Directors: J.D. Davis (Managing) S. Engelberg D. Wagenheim
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of a bird with its wings spread.
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
Re : K972938 Trade Name: Aurecast 10 Requlatory Class: II Product Code: EJT Dated: June 13, 1997 Received: June 20, 1997
AUG 25 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 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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. Please note: concerning your device in the Federal Reqister. this response to your premarket notification submission does not affect any obligation you might 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 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) 594-4692. 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
Time A 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):_____________________________________________________________________________________________________________________________________________________
AURECAST 10 levice Name:
Indications For Use:
Dental casting alloy for making dental restorations and appliances.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Swan Runner
Division Sign-Off) Division of Dental, Infection Control, and General Hospital I 510(k) Number
-Prescription Use y/2 er 21 CFR 801.109)
OR
Over-The-Counter Use No
(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.