(77 days)
Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration.
Medium gold palladium based casting alloy
The provided text is a 510(k) summary for a dental casting alloy named HIPALLAUR 51. This document describes the device and compares it to a legally marketed predicate device (Jelenko Cameo) based on composition and physical/mechanical properties to demonstrate substantial equivalence. It does not describe an AI/ML device or a study with acceptance criteria and device performance in the way requested in the prompt.
Therefore, many of the requested categories are not applicable to the provided text. I will address the relevant information that can be extracted.
Not Applicable:
- A table of acceptance criteria and the reported device performance: This document is a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific, predefined acceptance criteria for a new AI/ML device performance. The "performance" here is comparison to a predicate.
- Sample size used for the test set and the data provenance: There isn't a "test set" in the context of an AI/ML device. The comparison is based on material properties.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable for a dental alloy.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a dental alloy.
- The type of ground truth used: Not applicable in the AI/ML sense. The "ground truth" for this submission is established chemical composition and physical properties measured by standard methods.
- The sample size for the training set: Not applicable for a dental alloy.
- How the ground truth for the training set was established: Not applicable for a dental alloy.
Applicable Information (based on interpretation of the prompt for a non-AI/ML device):
The "acceptance criteria" for a 510(k) submission like this are implicitly demonstrating substantial equivalence to a legally marketed predicate device. The "device performance" is presented through direct comparison of material properties.
1. Table of Acceptance Criteria and the Reported Device Performance
For this 510(k) submission, the implicit "acceptance criteria" are that the new device (HIPALLAUR 51) has a composition and physical/mechanical properties that are sufficiently similar to the legally marketed predicate device (Jelenko Cameo) to ensure equivalent safety and effectiveness.
Here's a table synthesizing the comparison presented:
| Property | Acceptance Criteria (Predicate: Jelenko Cameo) | Reported Device Performance (HIPALLAUR 51) | Discussion/Outcome (Substantial Equivalence) |
|---|---|---|---|
| Composition (weight%) | |||
| Au | 52.5 | 50.6 | Difference < 5% (52.5 vs 50.6) |
| Ag | 16 | 17.6 | Difference < 5% (16 vs 17.6) |
| Pt | 0 | 0.2 | Minor addition (noble) |
| Pd | 27 | 26.5 | Difference < 5% (27 vs 26.5) |
| Sn | 2 | 2.1 | Difference < 5% (2 vs 2.1) |
| In | 2.5 | 2 | Difference < 5% (2.5 vs 2) |
| Fe | 0 | 0.3 | Minor addition |
| Mn | x (<1%) | 0.5 | Both under 1% |
| Re | x (<1%) | 0.1 | Both under 1% |
| Ir | x (<1%) | 0 | Both under 1% |
| Ru | 0 | 0.1 | Minor addition (noble) |
| Physical/Mechanical Properties | |||
| Melting point range Solid. (°C) | 1200 | 1220 | Similar range |
| Melting point range Liquid (°C) | 1280 | 1240 | Similar range |
| Hardness (Vickers 5/30) Soft | 240 | 250 | Close |
| Hardness (Vickers 5/30) Hard | N/A (not reported for Cameo) | 265 | Data provided for new device |
| Yield strength (MPa) Soft | 448 | 560 | Higher for new device |
| Yield strength (MPa) Hard | N/A (not reported for Cameo) | 630 | Data provided for new device |
| Elongation (%) Soft | 12 | 5 | Lower for new device |
| Elongation (%) Hard | N/A (not reported for Cameo) | 3 | Data provided for new device |
| CTE (x10-6/°C) | 14.9 | 14.5 | Close |
| Density (g/cm3) | 14.1 | 14.1 | Identical |
Summary of the study/comparison:
The study demonstrates that "All the elements above 1 % are the same in both alloys. The difference in concentration for every component is less than 5 %. The elements under 1 % content are either noble ones, or the ones that oxidize and be eliminated during melting. Consequently, they have little effect upon the characteristics of the alloys." The conclusion states, "Up to 99 % both alloy consist of the same elements. This suggests that chemical and biological behaviour should be similar."
2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in the context of a statistical study for device performance. The data provenance is from the manufacturer, Aurex Precious Metal Industries (PTY) LTD., based in the Republic of South Africa. The data appears to be based on laboratory testing of material properties, rather than clinical trials with human subjects. The data is retrospective in the sense that the predicate device's data is existing, and the new device's data is measured for comparison.
6. If a standalone was done:
Yes, the comparison of the HIPALLAUR 51 alloy's composition and physical/mechanical properties, as measured according to ANSVADA 5 and ISO 9693 standards, is a standalone assessment of the device's characteristics against those of the predicate device. There is no human-in-the-loop component for evaluating the performance of a dental alloy.
7. The type of ground truth used:
For the purpose of this 510(k) submission, the "ground truth" is established by:
- Chemical Analysis: Determining the exact elemental composition (weight%) of both the predicate and new alloys.
- Standardized Physical/Mechanical Property Testing: Measurements of properties like melting point, hardness, yield strength, elongation, CTE, and density, conducted according to recognized industry standards (ANSVADA 5 and ISO 9693). These standards define the accepted methods for obtaining these measurements, ensuring consistency and reliability of the "ground truth" data.
{0}------------------------------------------------
SEP - 5 1997
Image /page/0/Picture/1 description: The image shows a logo for AUREX. The logo consists of a geometric shape above the word "AUREX". The geometric shape appears to be made of three overlapping triangles, creating an abstract design. 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
-15-
17295
510 (k) Summary
Trade name: Common name: Classification name: Class ification number: HIPALLAUR 51 Dental casting alloy Gold based alloys and precious metal alloys for clinical use EJT
Legally marketed device: Jelenko Cameo Description of the device: Medium gold palladium based casting alloy Intended use of the device: Type IV restoration with porcelain veneering
Summary of the technological characteristics
Test methods applied: as in ANSVADA 5 and ISO 9693
Comparison of composition:
| ALLOY | COMPOSITION (weight%) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Name | Au | Ag | Pt | Pd | Sn | In | Fe | Mn | Re | Ir | Ru | |
| Legal | Cameo | 52.5 | 16 | 0 | 27 | 2 | 2.5 | 0 | x | x | x | 0 |
| New | Hipallaur 51 | 50.6 | 17.6 | 0.2 | 26.5 | 2.1 | 2 | 0.3 | 0.5 | 0.1 | 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 (%) | CTE (x10-6/°C ) | Density (g/cm3) | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Name | solid. | liquid | soft | hard | soft | hard | soft | hard | |||
| Legal | Cameo | 1200 | 1280 | 240 | 448 | 12 | 14.9 | 14.1 | |||
| New | Hipallaur 51 | 1220 | 1240 | 250 | 265 | 560 | 630 | 5 | 3 | 14.5 | 14.1 |
Discussion
All the elements above 1 % are the same in both alloys. The difference in concentration for every component is less than 5 %. The elements under 1 % content are either noble ones, or the ones that oxidize and be eliminated during melting. Consequently, they have little effect upon the characteristics of the alloys.
Conclusion
Up to 99 % both alloy consist of the same elements. This suggets that chemical and biological behaviour should be similar.
Image /page/0/Picture/21 description: The image shows a logo with the letters "TUV" in bold, black font. Above the letters are two small squares. The logo is enclosed in a rounded rectangular shape with a double border. The logo appears to be a certification mark.
{1}------------------------------------------------
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
Re : K972951 Hipallaur 51 Trade Name: Regulatory 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, 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 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:
{2}------------------------------------------------
Page 2 - Mr. Davis - ----
this response to your premarket notification submission does not affect any obligation you might have under sections 531 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) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note one 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
K. Matust
Timothy A. Ulatowski Diredtor Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
510(k) Number (if known):_
Device Name: HIPALLAUR 51
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)
S. Vanover
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
Prescription Use er 21 CFR 801.109)
OR
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.