(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) premarket notification for a dental casting alloy named "Aurecast 4". This document describes the device, its intended use, and compares its technological characteristics to a legally marketed predicate device ("Argen Argenco 9").
However, the document does not describe a study in the context of typical AI/medical device performance evaluation (e.g., clinical trial data, diagnostic accuracy studies). Instead, it relies on a comparison of a material's physical and chemical properties to a predicate device to establish substantial equivalence. Therefore, many of the requested sections regarding AI device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment are not applicable.
Here's how the available information from the document addresses the request:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Predicate Device (Argenco 9) Acceptance Range / Value | New Device (Aurecast 4) Reported Performance |
|---|---|---|
| Composition (weight%) | ||
| Au | 4% | 4% |
| Ag | 45.7% | 45.7% |
| Pd | 30.3% | 30.3% |
| Cu | 18.5% | 17.6% |
| Zn | 1.5% | 2.3% |
| Ir | 0.05% | 0% (x is less than 1%) |
| Ru | 0% | 0.1% (x is less than 1%) |
| Physical/Mechanical Properties | ||
| Melting Point Range (Solid) | 940 °C | 940 °C |
| Melting Point Range (Liquid) | 1020 °C | 1020 °C |
| Hardness (Vickers 5/30) - Soft | 195 | 195 |
| Hardness (Vickers 5/30) - Hard | 265 | 265 |
| Yield Strength (MPa) - Soft | 460 | 460 |
| Yield Strength (MPa) - Hard | 700 | 700 |
| Elongation (%) - Soft | 10% | 10% |
| Elongation (%) - Hard | 3% | 3% |
| Density (g/cm³) | 10.6 | 10.6 |
Acceptance Criteria for Substantial Equivalence: The unspoken acceptance criterion is that the new device's composition and physical/mechanical properties must be "practically identical" or fall within acceptable ranges similar to the legally marketed predicate device (Argenco 9) as demonstrated by the comparison tables provided. The FDA's letter states the device was found "substantially equivalent."
2. Sample size used for the test set and the data provenance
Not applicable. This is not a study assessing diagnostic performance or clinical outcomes on a patient test set. The "test" performed involved material characterization tests (per ANSI/ADA 5 and ISO 8891) on the Aurecast 4 alloy itself, and the results were compared to the established properties of the predicate device. The document does not specify the number of samples of the alloy tested for its properties or the provenance of this test data beyond the general mention of "test methods applied."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no "ground truth" in the clinical sense of expert assessment for a patient-related dataset. The "ground truth" in this context refers to the measured material properties of the alloy and its predicate, established via standardized physical and chemical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 3.
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 device or a diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a material (dental alloy), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the objectively measured physical and chemical properties of the material (Aurecast 4) and its comparison to the established properties of the predicate device (Argenco 9). These properties are determined through standardized test methods (ANSI/ADA 5 and ISO 8891).
8. The sample size for the training set
Not applicable. There is no training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no training set.
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Image /page/0/Picture/0 description: The image shows a logo with a geometric design above the word "AUREX". The geometric design consists of three overlapping triangles, creating a complex shape. The word "AUREX" is written in a bold, sans-serif font, with a horizontal line underlining it.
972937
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 4 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: Argen Argenco 9 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 | Ir | Ru | |
| Legal | Argenco 9 | 4 | 45.7 | 30.3 | 18.5 | 1.5 | 0.05 | 0 |
| New | Aurecast 4 | 4 | 45.7 | 30.3 | 17.6 | 2.3 | 0 | 0.1 |
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 | Argenco 9 | 940 | 1020 | 195 | 265 | 460 | 700 | 10 | 3 | 10.6 |
| New | Aurecast 4 | 940 | 1020 | 195 | 265 | 460 | 700 | 10 | 3 | 10.6 |
Discussion
The two alloys are practically identical.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract image of an eagle.
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
Re : K972937 Aurecast 4 Trade Name: Requlatory Class: II Product Code: EJT Dated: June 13, 1997 June 20, 1997 Received:
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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory 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 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
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ 'evice 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)
Susan Runser
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital,Devices
510(k) Number K922037
Prescription Use er 21 CFR 801.109)
Over-The-Counter Use No
§ 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.