(77 days)
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
Palladium silver based casting alloy
Here's an analysis of the provided text regarding the Palceram 56 dental casting alloy, addressing your request for acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary for a medical device seeking market clearance in the US. For such devices, often the "study" proving acceptance criteria is a comparison to a legally marketed predicate device demonstrating substantial equivalence, rather than a standalone clinical trial in the way a pharmaceutical might have. This document primarily focuses on demonstrating that the new device is as safe and effective as an existing one through comparison of material properties.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" here are implicitly linked to the properties of the legally marketed predicate device, "Aurium Aurolite IK." The new device, "Palceram 56," is considered acceptable if its properties are comparable or within acceptable ranges relative to the predicate. The document doesn't explicitly state numerical acceptance thresholds for each property, but rather presents a side-by-side comparison to demonstrate similarity.
| Property/Test | Acceptance Criteria (Implicitly from Aurium Aurolite IK) | Reported Palceram 56 Performance | Outcome (Comparison) |
|---|---|---|---|
| Composition (weight%) | |||
| Ag | ~30% | 32% | Similar |
| Pd | ~58% | 56.5% | Similar |
| Sn | ~6% | 3.9% | Reasonably similar (minor difference) |
| In | ~4% | 7.3% | Reasonably similar (minor difference) |
| Zn | <1% (x) (present) | 0% | Zn not present, Ru is present. "Same constituents save a minor concentration of Fe vs. Zn." (Considered acceptable difference) |
| Ru | <1% (x) (present) | 0.3% | Ru not present in predicate. |
| Physical and Mechanical Properties | |||
| Melting point range (oC) - Solidus | 1232 | 1200 | Similar |
| Melting point range (oC) - Liquidus | 1282 | 1230 | Similar |
| Hardness (Vickers 5/30) - soft | 260 | 200 | Lower (soft state) |
| Hardness (Vickers 5/30) - hard | N/A (not reported for predicate) | 265 | Higher (hard state) |
| Yield strength (MPa) - soft | 552 | 470 | Lower (soft state) |
| Yield strength (MPa) - hard | N/A (not reported for predicate) | 600 | Higher (hard state) |
| Elongation (%) - soft | 14 | 8 | Lower (soft state) |
| Elongation (%) - hard | N/A (not reported for predicate) | 3 | Lower (hard state) |
| CTE (x10-6/oC) | 14.9 | 14.9 | Identical |
| Density (g/cm3) | 11.3 | 11.1 | Similar |
Discussion: The conclusion states: "Identical main elements and the similarity of their content can result in similar chemical and biological effect." This implies that despite some numerical differences in mechanical properties, the overall "similarity" is deemed sufficient for regulatory acceptance, especially given the "minor concentration of Fe vs. Zn" for trace elements and the fact that the device meets industry standards (ANSI/ADA 5 and ISO 9693). The differences in 'soft' vs 'hard' for some properties are likely related to how the alloy is processed/used in practice.
Study Details (Based on available information)
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. For material testing like this, it would involve a certain number of specimens of the alloy for each test (e.g., tensile strength, hardness, etc.). The document doesn't provide these specific specimen counts.
- Data Provenance: The data comes from the manufacturer, Aurex Precious Metal Industries (PTY) Ltd. of South Africa ("Republic of South Africa" listed as country of origin). The testing seems to be based on adherence to international standards (ANSI/ADA 5 and ISO 9693), which implies standardized laboratory testing. It is retrospective in the sense that the data represents characterization of the material after its development.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of submission (510(k) for material equivalence) typically does not involve experts establishing "ground truth" in the clinical sense (e.g., radiologists interpreting images). Instead, the "truth" is established by the results of standardized material property tests performed according to recognized industry standards (ANSI/ADA 5 and ISO 9693). The experts involved would be materials scientists and engineers who conducted the tests and interpreted the results against those standards and the predicate device's known properties. Their qualifications are implicitly that they are capable of performing and interpreting these technical tests.
4. Adjudication method for the test set:
- Not applicable as this is not a subjective interpretation task requiring adjudication. The "adjudication" is performed by comparing the quantifiable test results to the predicate device and relevant standards.
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 a material science characterization for a dental alloy, not an AI-powered diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. As above, this is not an algorithm or software device.
7. The type of ground truth used:
- Objectively measured material properties obtained through standardized laboratory tests (e.g., melting point, hardness, yield strength, elongation, CTE, density) and elemental composition analysis. The "ground truth" for comparison is the known and characterized properties of a legally marketed predicate device and the requirements of relevant industry standards.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of material characterization unless it refers to samples used for initial development and optimization of the alloy formulation. The document does not provide details on such development.
9. How the ground truth for the training set was established:
- Not applicable. No training set as per the definition of AI/machine learning. The "ground truth" in material science is derived from direct measurement and adherence to established physical and chemical principles and standards.
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SEP 1997
Image /page/0/Picture/1 description: The image shows a logo with a stylized mountain range above the word "AUREX". The mountain range is composed of three overlapping triangles, creating a sense of depth and complexity. The word "AUREX" is written in a bold, sans-serif font, with a horizontal line underlining the text.
P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918
-19-
510 (k) Summary
Trade name: Common name: Classification name: Class ification number: EJT
PALCERAM 56 Dental casting alloy Gold based alloys and precious metal alloys for clinical use
Legally marketed device: Aurium Aurolite IK Description of the device: Palladium silver based 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 | Ag | Pd | Sn | In | Zn | Ru | |
| Legal | Aurolite IK | 30 | 58 | 6 | 4 | x | x |
| New | Palceram 56 | 32 | 56.5 | 3.9 | 7.3 | 0 | 0.3 |
x is less than 1 %
Comparison of physical and mechanical properties
| ALLOY | Melting point range (oC) | Hardness (Vickers 5/30) | Yield strength (MPa) | Elongation (%) | CTE (x10-6/oC) | Density (g/cm3) | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Name | solid. | liquid | soft | hard | soft | hard | soft | hard | |||
| Legal | Aurolite IK | 1232 | 1282 | 260 | 552 | 14 | 14.9 | 11.3 | |||
| New | Palceram 56 | 1200 | 1230 | 200 | 265 | 470 | 600 | 8 | 3 | 14.9 | 11.1 |
Discussion
The same constituents can be found in both alloys save a minor concentration of Fe vs. Zn.
Conclusion
Identical main elements and the similarity of their content can result in similar chemical and biological effect.
Image /page/0/Picture/20 description: The image shows a logo with the text "TUV CERT" stacked on top of each other. The logo is enclosed in a rounded square. The text is in a bold, sans-serif font. The logo is black and white.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 1997
Mr. Jerome D. Davis Managing Director Aurex Precious Metal Industries (PTY) Ltd. P.O. Box 509 Edenvale 1610 Republic of South Africa
K972955 Re : Palceram 56 Trade Name: Regulatory Class: II Product Code: EJT June 13, 1997 Dated: 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 able beated in the enouble 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 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 ma 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
Timot U 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:
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 Simmons
(Division Sion-GM 510
Prescription Use Per 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.