(67 days)
Dental casting alloy for making dental restorations and appliances.
High gold casting alloy
The provided document is a 510(k) premarket notification for a dental casting alloy, Aurecast Bio 59PF. It demonstrates substantial equivalence to a predicate device, Jelenko Sturdicast, based on material composition and physical/mechanical properties. However, it does not describe a study involving a medical device with an AI/ML component or a study that typically involves acceptance criteria as would be found for diagnostic or screening devices.
Therefore, most of the information requested in your prompt (e.g., sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set) is not applicable to this type of submission. The document focuses on demonstrating chemical and physical property similarities, which is a different type of evaluation than performance metrics for an AI system.
Here's a breakdown of what can be extracted based on the provided document:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are implicitly defined by the "Comparison of physical and mechanical properties" table, where the new device's properties are compared to the legally marketed predicate device (Jelenko Sturdicast). The aim is to show "little difference" or similar characteristics.
| Property | Predicate Device (Sturdicast) Performance | New Device (Aurecast Bio59PF) Performance | Acceptance Criteria (Implicit) |
|---|---|---|---|
| Composition (weight%) | "The noble metal content of the two alloys differs very little (2%). The (Ag+Cu) content is also very close. Aurecast Bio59PF uses Zn as deoxidizing agent." (The specific acceptance range is not quantified but implies close matching). | ||
| Noble Metal (Au + Pt + Pd) | 60 + 0 + 3.8 = 63.8% | 58.9 + 4.1 + 0 = 63% | Within 2% difference |
| Ag + Cu | 22 + 14 = 36% | 23 + 12.3 = 35.3% | "very close" |
| Melting Point Range (°C) | "Physical and mechanical properties shoe only little difference." (Specific numeric ranges for acceptance are not provided, but the values are observed to be close). | ||
| Solidus | 860 | 858 | Close to predicate |
| Liquidus | 905 | 884 | Close to predicate |
| Hardness (Vickers 5/30) | "Physical and mechanical properties shoe only little difference." | ||
| Soft | 175 | 205 | Close to predicate |
| Hard | 270 | 270 | Close to predicate |
| Yield Strength (MPa) | "Physical and mechanical properties shoe only little difference." | ||
| Soft | 352 | 345 | Close to predicate |
| Hard | 703 | 520 | This shows a larger difference for 'hard' (703 vs 520), but the conclusion states "physical and mechanical properties show only little difference" and addresses it by stating "With the exception of a very small amount of Zn and In the two alloys have similar constitution and mechanical characteristics." The acceptance is therefore that these differences are not considered substantial enough to warrant a different regulatory conclusion. |
| Elongation (%) | "Physical and mechanical properties shoe only little difference." | ||
| Soft | 40 | 19 | Close to predicate |
| Hard | 8 | 6 | Close to predicate |
| Density (g/cm3) | 14.1 | 14.2 | Close to predicate |
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 typically involves multiple samples for reproducibility, but the exact number isn't mentioned in this summary.
- Data Provenance: The tests were performed as per ANSI/ADA 5 and ISO 8891 standards (international standards). The manufacturer is Aurex Precious Metal Industries (PTY) LTD, Republic of South Africa. The testing would have been conducted to support this submission. It is generally considered prospective for the specific purpose of the 510(k).
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)
- Not Applicable. This is a material science characterization, not a diagnostic or AI-driven medical device evaluation. Ground truth, in this context, refers to the measured physical and chemical properties of the alloys, which are objectively determined through standardized laboratory tests, not through expert interpretation of images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3. Measurement of material properties doesn't involve adjudication as understood in clinical studies.
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
- No. This is not an AI/ML or diagnostic imaging device.
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 (expert consensus, pathology, outcomes data, etc)
- The "ground truth" (or reference standard) is the measured chemical composition and physical/mechanical properties of the alloys, determined through established and standardized laboratory test methods (ANSI/ADA 5 and ISO 8891).
8. The sample size for the training set
- Not Applicable. There is no AI/ML component, thus no "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
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AUG 2 S
Image /page/0/Picture/2 description: The image shows a logo for AUREX. The logo consists of two overlapping triangles, with the word "AUREX" written below them. There is a line underneath the word AUREX. The triangles and text are black, and the background is white.
P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918
-5-
510 (k) Summary
| Trade name: | AURECAST BIO 59 PF |
|---|---|
| Common name: | Dental casting alloy |
| Classification name: | Gold based alloys and precious metal alloys for clinical use |
| Class ification number:EJT |
Legally marketed device: Jelenko Sturdicast Description of the device: High gold 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 | Pt | Pd | Cu | Zn | In | Ir | |
| Legal | Sturdicast | 60 | 22 | 0 | 3.8 | 14 | 0 | x | x |
| New | AurecastBio59PF | 58.9 | 23 | 4.1 | 0 | 12.3 | 1.5 | 0 | 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 (%) | Density (g/cm3) | ||||
|---|---|---|---|---|---|---|---|---|---|
| Name | solid. | liquid | soft | hard | soft | hard | soft | hard | |
| Legal Sturdicast | 860 | 905 | 175 | 270 | 352 | 703 | 40 | 8 | 14.1 |
| New Aurecast | 858 | 884 | 205 | 270 | 345 | 520 | 19 | 6 | 14.2 |
| Bio59PF |
Discussion
The noble metal content of the two alloys differs very little (2%). The (Ag+Cu) content is also very close. Aurecast Bio59PF uses Zn as deoxidizing agent. Physical and mechanical properties shoe only little difference.
Conclusion
With the exception of a very small amount of Zn and In the two alloys have similar constitution and mechanical characteristics. It may be assumed that the corrosion and tamish resistance and the biological effect do not differ substantially.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 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 entwined around it. Above the caduceus, the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular fashion. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 26 1997
Mr. Jerome D. Davis Managing Director Aurex Precious Metal Industries (PTY) LTD P.O. Box 509 Edenvale 1610 Republic of South Africa
Re: K972939 Aurecast Bio 59PF Trade Name: Requlatory Class: II Product Code: EJT 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, qood 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. ಕ್ಕೆ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as sec 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 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 diaqnostic 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 qeneral 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.ffla.gov/cdrh/dsmamain.html".
Sincerely yours,
Alidatist
Timo 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):_____________________________________________________________________________________________________________________________________________________
'evice Name: AURECAST BIO 59PF
Indications For Use:
Dental casting alloy for making dental restorations and appliances.
SE WITH DENTAL PORCELAINS NI (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruma
(Division Sign-Off Division of Dental, it and General Hos 510(k) Number
escription Use
(21 CFR 801.109)
Over-The-Counter Use
§ 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.